Nmpa cfda


The Catalog of Federal Domestic Assistance (CFDA) is a compendium of assistance programs offered by various U. CFDA issued draft guidelines in mid-March that would allow multinational pharma companies to run Phase I trials in China for the first time. Die wiederum löste die China Food and Drug Administration (CFDA) ab. 11. korea. The UDI shall be composed of product identifier and manufacturing identifier. New York, NY CDE stands for Centre of Drug Evaluation (Drug Administration Law of SFDA of China). The manufacturers of APIs, excipients and packaging materials do not need to conduct sample testings any more in China. Main Responsibilities-- Registration & Market 国家食品药品监督管理总局(cfda)则不再保留。 上述通知的发布意味着,机构改革后,国家药品监督管理局的英文名称正式确定为NMPA。 结合国家药品监督管理局的中文名称分析,NMPA的全称为国家药品监督管理局National Medical Products Administration。 It was previously known as the China Food and Drug Administration (CFDA). Patients with NSCLC carrying EGFR activating mutations, such as exon 19 deletions, L858R mutation, or T790M mutation, are candidates for the EGFR-targeted therapy with EGFR-TKIs. China’s National Medical Products Administration (NMPA) published overseas inspection results in late January, highlighting 17 overseas medical device and IVD manufacturers that were cited, including BD and Boston Scientific. These cDMF filings allow global pharmaceutical companies to manufacture and sell pharmaceutical products in China, utilizing many of JRS PHARMA’s excipients. In the document, it says that the English name of China FDA has been changed to “National Medical Products Administration “NMPA”, so applicants who submit the materials beginning in September should use the new application letter with the new name on it. State Intellectual Property Office. 2018 wurde die neue offizielle Website von NMPA (National Medical Products Administration) vormals CFDA (China Food and Drug  The NMPA (National Medical Products Administration, former CFDA) is responsible for the registration of all imported drugs, medical devices and cosmetics in  23 Sep 2019 From November 1, 2019, these CFDA-designated laboratories will not on the NMPA system to finish cosmetics registration, record-filing, and  13 Mar 2019 "[Because] the reorganisation of the CFDA has not yet been The National Medical Products Administration (NMPA) has taken over all  The China Food and Drug Administration (CFDA) recently published. The National Medical Products Administration (NMPA, former CFDA) is the Chinese agency tasked to draft laws and regulations for drugs and medical devices in China. 因报盘软件中所涉及"cfda"英文简称变更为"nmpa",自2018年9月1日起,请药品注册申报单位及时下载药品注册新版报盘程序进行填报。 各申请单位使用时如有问题,请拨打电话010-XXXXXXXX反馈意见,并随时关注更新情况,每次更新会标注具体更新日期。 The Chinese market for drugs and medical devices is increasing fast – and the CFDA (currently, National Medical Products Administration, NMPA) must ensure that any foreign company exporting medicinal products to China complies with the CFDA drug and medical device regulations and standards! National Medical Product Administration(NMPA) National Development and Reform Commission in respect of price supervision and anti -trust law enforcement. Until now, China only approved drugs that had been tested on people in China. Non-small cell lung cancer (NSCLC) is one of the most common types of the disease and accounts for approximately 85% of diagnoses. The draft exemption list is open for feedback and comments from health industries, manufacturers, and users until June 20, 2017. nmpa. Joining ICH . 1. 18, 2018 Outline: To fulfill the clinical need of public for medical devices, improve the innovation of medical device technology, this guideline is made according to the “Opinions on reforming the review and approval system to encourage the innovation of drugs and medical devices” by the General Office of the Central Committee of the CPC In China, the most important cosmetic legislation is Regulations Concerning the Hygiene Supervision over Cosmetics, which is currently being revised. CHINA: CFDA Officially Changed the English Name to NMPA – September, 2018 September 17, 2018 On August 29, a new notice from the department of drug registration has revealed that CFDA has changed to its official English name to ‘National Medical Product Administration (NMPA)’ which was also adopted by the medical device registration system. 182 and it is a . The drug regulatory authority of China, the National Medical Product Administration (NMPA, formerly CFDA) has set aggressive timelines for drug manufacturers to comply with electronic standards for safety report submissions. Office of Anti-Trust Committee, State Council. Fast and furious reform at the CFDA/NMPA It’s fair to say that the reform initiated in late 2015 by the CFDA, now under NMPA, has been broader, deeper, and has moved faster than anyone could have anticipated. J. In March 2018, China restructured the medical device authority from China Food and Drug Administration (Known as CFDA) to National Medical Products Administration (Known as NMPA), it is administered by the State Administration for Market Regulation (Known as SAMR). Medical Device and IVD Registration in China. *China NMPA (formerly CFDA) clarified Cell Therapy Regulations in December 2017 (the "Regulation") whereby all cell therapies are being treated as drug NDA/IND. nmpa. Having registered thousands of cosmetic products with a 97% success rate, see how we can simplify the process. 4/1 Rev. CFDA (now NMPA) Solicitation of Public Opinions on Rules of Medical Device Unique Identifier (UDI) (Draft for Comments, 1 st version) State Administration for Market Regulation *China NMPA (formerly CFDA) clarified Cell Therapy Regulations in December 2017 (the "Regulation") whereby all cell therapies are being treated as drug NDA/IND. QCAC INTERNATIONAL CONSULTINGone-stop brand services, brand IP right protection, corporate business security risk control, CFDA cosmetics registration, cultural brand communication & derivation, and exchanges between Chinese and foreign enterprises. Since 1-Sep, 2018, CFDA (China Food and Drug Administration) has changed its name to NMPA (National Medical Product Administration). China Food and Drug Administration ( CFDA) recently issued the latest Technical Guideline for Clinical Evaluation of Medical Devices. New guidelines to make China a more drug-friendly market. CFDA carried out on-site inspection of overseas production of imported medical instruments and found out that the Leica Biosystems Newcastle Ltd, UK had changed its suppliers for mouse IgG and hydrogen peroxide in the HER-2 Kit (immunohistochemistry). medical device companies to accelerate their  20. UBP1211 was approved by the NMPA (formerly CFDA) to conduct clinical trials, being one of the first Humira biosimilars developed by PRC companies. The Center for Medical Device Evaluation (CMDE) is responsible for conducting the dossier review during the medical device registration process. No. gov. In an effort to reduce repetitive clinical trials and to accelerate the process of medical device certification, data requirements are no longer limited to pre- or post-market clinical data. nmpa(旧cfda)の仕組み 取得の流れについて、 取得のための必要書類、 注意点 などを図を交えてお伝えしていきます。 まずは、nmpa(旧cfda)の全体像を掴み、 あなたの商品が中国市場で販売できるように準備を進めていきましょう。 Merck’s Keytruda (pembrolizumab) + Chemotherapy Receive NMPA’s (CFDA) Approval for 1L Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC April 2, 2019 June 14, 2019 Shiwani Sharma Shots: We can provide you with the NMPA (CFDA) registration service of medical products in mainland China, and help you sell your products legally in mainland China. com) 提示:国家药品监督管理局网站(www. org. CFDA Announcement No. The China Food and Drug Administration (CFDA) (now NMPA) is the administrative body responsible for the regulation of medical devices and pharmaceuticals on the Chinese mainland. , Kenilworth N. org has ranked N/A in N/A and 790,979 on the world. Hengrui, who owns the China rights to rivoceranib, received the approval from China National Medical Products Administration (NMPA, formerly known as CFDA) in 2014 to market the drug under the brand name Aitan ® in China for advanced gastric cancer. 42-2017. do TEL : 1588-9610 Regulations for the Supervision and Administration of Medical Devices. , Inc. The original name China FDA has been used since 2008. 2018 Am 04. com - China NMPA FDA,SFDA,CFDA,MOH,MOA,AQSIQ,CNCA,CIQ registration approval license for cosmetics,health food supplement,medical device,IVD,drug,infant milk According to the requirements of the Regulation of the People's Republic of China on the Disclosure of Government Information and the Implementation Plan for Disclosure of Administrative Affairs of NMPA in 2018 and adhered to the purpose of improving services, enhanced the network and information security, further strengthened the institution construction, completed the active disclosure catalogue, highlighted the disclosure of information in key areas, and made efforts to ensure the Provided by Alexa ranking, nmpa. Crucially the China Food and Drug Administration (“CFDA”) is seeking public comment on several lists of health food raw materials and auxiliary materials. NMPA was created in April 2018. ,Ltd is specialized inregistration and consultancy services for NMPA(CFDA). qcac-そのビジネスフィールドは、中国国家政府や各省政府の人脈を活かし、知的財産保護、ビジネスセキュリティ、及び日中投資総合コンサルティング業務まで幅広く展開しています。 The National Medical Products Administration (NMPA, former CFDA) is the Chinese agency tasked to draft laws and regulations for drugs and medical devices in China. The NMPA grants permission for clinical trials to be conducted in China in accordance with the provisions of the DAL, the RegImplemDAL, the SC-Opinions-No44, NMPA-No50, and the NMPA-No230. The management and supervision for medical devices in China is steadily becoming standardized and stringent. It was previously known as the China Food and Drug Administration (CFDA). The China NMPA (formerly CFDA) accepted the Company's IND application for a Phase II trial for AlloJoin®, CBMG's "Off-the-Shelf" allogenic haMPC therapy for the treatment of Knee Osteoarthritis Biogen’s Spinraza (nusinersen) Receives NMPA (CFDA) Approval for Spinal Muscular Atrophy (SMA) Aged 6wks. The new regulation replaced the excipient itself registration system. Dez. cfda행정사항접수서비스센터가 18년8월29일자에 발표한 문서에 따르면, 기존 중국식약총국 "cfda"명칭이 "nmpa"로 변경되었다고 합니다. domain. There are approximately 781,000 new cases of lung cancer diagnosed in China each year, equaling approximately 15 new cases every 10 minutes. Sfdachina. ChinaMed Device compiled the data and made four charts to  4 Jan 2019 On December 28th, 2018, National Medical Products Administration (NMPA) issued 'Administrative Regulations of Drug and Medical Device  6 Sep 2018 Executive Summary. The Basics of the Catalog of Federal QCAC INTERNATIONAL CONSULTINGone-stop brand services, brand IP right protection, corporate business security risk control, CFDA cosmetics registration, cultural brand communication & derivation, and exchanges between Chinese and foreign enterprises. CFDA was born in 2013 to emphasize its growing independence as an industry regulator. NMPA consists of 9 subordinate departments, including a “Cosmetic Safety Supervision Department”(化妆品监督管理司), which will undertake cosmetics registration and filing, drafting and supervising the implementation of cosmetic standards, classification rules, technical guidelines and censorship, as well as conducting on-site and sampling inspection, penalizing illegal activities and monitoring adverse reactions. The restructuring reflects the agency’s honed focus on pharmaceuticals and medical devices, versus both food and drugs under the CFDA. 2 *International Federation of Pharmaceutical Manufacturers and Associations, Facts & Figures 2017 As China’s National Medical Products Administration (NMPA) moves closer to finalizing its 2018 draft Amendments to the Regulations on the Supervision and Administration of Medical Devices, medical device companies should be aware of the significant impact these changes will have on the global medical device market. Applicants who want to appoint a Chinese distributor as NMPA Legal Agent should be aware of the risks involved. Updated in January 2015. 21世纪经济报道21财经 APP 卢杉北京报道. These lists will have a direct impact on filing and registration of products by international supplement companies in China. NMPA (CFDA) issued the Technical Guideline on AI-Aided Software on June 28, 2019. The format and arrangement of content stipulated are now part of the regulatory requirements to file for NMPA submission. CCC強制認証を管轄していた国家質量監督検験検疫総局(AQSIQ)がなくなり、 国家市場監督管理総局という組織になっていると聞きましたが、組織改編の状況を教え て  2019年5月20日 继前CFDA(现NMPA)在2017年6月正式成为ICH全球第8个监管机构成员 In June 2017, CFDA joined ICH as the 8th regulatory member globally  Embed Tweet. According to the decision of the Central Committee of the CCP on March 17th, 2018, the CFDA was replaced by the NMPA (National Medical Products Administration). The NMPA (National Medical Products Administration, former CFDA) is responsible for the registration of all imported drugs, medical devices and cosmetics in China. “Applicants can directly apply for drug listing registration after the completion of the international multicenter drug clinical trials,” the China Food & Drug Administration (CFDA) disclosed in a statement. Retired Cadres Bureau (离退休干部局) Responsible for the work of retired cadres. The CFDA, like its foreign counterparts, plans to exercise its jurisdiction over foreign legal manufacturers and may arrange overseas GMP inspections in the future. 205. CFDA in China (now named NMPA) for Medical Device and Pharmaceutical Regulations The China Food and Drug Administration (CFDA) (now NMPA) is the administrative body responsible for the … Read More The China FDA (CFDA) released a Notice on Matters Related to Medical Device Re-registration on December 9, 2013. LSKB, which holds the global rights (ex-China), has completed enrollment of a global (12 countries including US, Japan, Korea, Italy, Germany, and Russia) phase 3 clinical trial of rivoceranib in advanced or metastatic gastric cancer patients. However, related regulations and personnel responsibilities are expected to remain unchanged. New CFDA Requirements and its Implementation Yi Yang, Senior Principal Programmer Sep 4, 2018 PharmaSUG Single Day Event Tokyo, Japan And because we understand the specifics of the region, we can help guide you to becoming a Market Authorization Holder in China and keep everything NMPA-compliant along the way. org reaches roughly 360 users per day and delivers about 10,801 users each month. In China, the regulatory body for the approval of medicines, including biologicals, is the National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA: simplified Chinese: 国家食品药品监督管理局). The session will cover key China market access updates: NMPA (CFDA) Major regulatory and clinical affairs updates, IP reform, Reimbursement and their implications on overseas manufacturers. caiqtest. 因報盤軟件中所涉及"cfda"英文簡稱變更為"nmpa",自2018年9月1日起,請藥品註冊申報單位及時下載藥品註冊新版報盤程序進行填報。 各申請單位使用時如有問題,請撥打電話010-88330526反饋意見,並隨時關注更新情況,每次更新會標註具體更新日期。 Understanding NMPA is CRUCIAL for medical device companies planning to expand to the Chinese market. The National Medical Products Administration (NMPA) (formerly the China Food and Drug Administration or CFDA) has released new guidelines on preparing clinical trial data generated overseas. cn)因技术维护需要,将从2019年 10月7日起暂停访问,预计于2019年10月14日前恢复,给您带来的不便敬请谅解! 国家食药监总局英文简称改为“NMPA” “CFDA”成为历史. Q. 9 Classification of medical devices MEDDEV 2. A. In the latest in a series of regulatory changes in China, the national drugs regulator has apparently been renamed the National Medical Products Administration (NMPA), while the country's essential drugs list has been expanded to include more oncology and pediatric drugs, which will be fully reimbursed. The fees vary for domestic and imported products, generic drugs and medical devices. com - China NMPA FDA,SFDA,CFDA,MOH,MOA,AQSIQ,CNCA,CIQ registration approval license for cosmetics,health food supplement,medical device,IVD,drug,infant milk Provided by Alexa ranking, nmpa. So, all CFDA and SFDA on this website default mean NMPA. Parexel has a deep bench of former CFDA/NMPA Regulators on statff who shaped and implemented regulations in China. The new regulations are applicable to medical devices in Class II and Class III. nmpa ,前身为cfda)药品审评中心(cde)正在对替雷 利珠单抗用于治疗r/r ch患者l (被纳入优先审评)和治疗先前接受过治疗的局部晚 期或转移性尿路上皮癌患者的新药上市申请(nda)进行审评。百济神州与新基公司达 To make the Chinese market more accessible to the international market in terms of regulatory procedures and product approvals, the National Medical Products Administration (NMPA) of China, formerly known as the Chinese Food and Drug Administration (CFDA), took a step forward and changed several guidelines and frameworks. China NMPA (FDA) Pharmaceuticals Drug Administration or CFDA) during the China NMPA Executive Leadership Engage senior officials from the NMPA NMPA (previously known as CFDA) recently published its replies to some common questions regarding the cosmetics supervision and management in an  4 Sep 2018 National Medical Product Administration(NMPA) standards. CFDA(특수) & NMPA(비특수) 비 특수화장품의 NMPA 제도변경 후 많은 업체 들의 고민은 당연 “경내책임자”입니다, 이에 코스모스코리아는 신금정과 협업하여 이  In 2015, the China Food and Drug Administration (CFDA) (now NMPA, National Medical Product Administration) issued technical guidance on the development  2019年4月29日 长桑技术通过采集脉搏容积波信号的方式计算人体血压等参数的模型。 2018年10月9日 Grace Fu Palma – US CEO. Medical Products -NMPA (CFDA) Registration Service In Mainland China Beijing Hengxin Boen Medical Technology Co. Despite the appointments of key leadership positions at the SMRA, Decree of the State Council of the People’s Republic of China. The National Medical Products Administration (NMPA), previously the China Food and Drug Administration (CFDA), is the institution responsible for pharmaceuticals and medical devices regulations in China. 14. § Major NMPA (CFDA) Updates in 2018 (Hainan policy, new classification rules, legal agent, registration holder system, overseas clinical data etc. For drug manufacturers, it is mandatory to submit SUSARs in ICH E2B R3 format from 01 May 2019. In China, Medical Devices (MDD) and In Vitro Diagnostic (IVD) reagents are regulated by following laws: The Regulations for the Supervision and Administration of Medical Devices (Decree No. Field visits and interview: over 50 field visits and interview. The CFDA doesn’t charge a registration fee. Our NMPA (CFDA) regulatory services include: RA, regulatory strategy, regulatory submissions, clinical evaluation reports (CER), clinical trials, QA, GMP and post-market compliance. and Merck & Co. , Ltd. org has ranked N/A in N/A and 8,551,543 on the world. 18 Sep 2018 China Food and Drug Administration (CFDA), recently changed its English name to the National Medical Products Administration (NMPA). Exporters should appoint a Chinese legal entity for the pre-market application. ” NMPA is an organization under the "State Administration for Market Regulation" (SAMR) that was found in March 2018 integrating the former: State Administration for industry and commerce of the PRC (SAIC) General Administration of Quality Supervision, Inspection and Quarantine of the PRC (AQSIQ) China Food and Drug Administration (CFDA) The Rules for Unique Device Identification System in China is issued by the NMPA/CFDA on August 23rd, 2019 and effective from October 1 st, 2019. (Innovent) (HKEX: 1801), a world-class China-based biopharmaceutical company that develops and commercializes high quality drugs, announced today that National Medical Products Administration (NMPA, successor to CFDA) has accepted its new drug application (NDA) for adalimumab biosimilar candidate (IBI303). Overseas inspection is the global common way for medical device inspection and one of the important steps for Chinese medical device inspection to be internationalized. LSKB, which holds the global rights (ex-China), has completed enrollment of a global (12 Between September 10 and October 31, 2019, cosmetics enterprises can either select a laboratory that has been published on the NMPA system to finish cosmetics registration, record-filing, and inspection online or follow the original procedures, offline, through a CFDA-designated institution. 13, 2018 /PRNewswire/ -- Innovent Biologics, Inc. cn; Li Yijie Principal Staff Member Need to obtain CFDA Approval for your Medical Devices as European Manufacturer? CCG can provide you a full custom service for CFDA certification . CFDA: CFDA Issues Technical Guideline for Clinical Evaluation of Medical Devices. The main authority for cosmetics is National Medical Products Administration (NMPA), previous called CFDA. NEEQ). The NMPA has initiated a series of reform documents, it’s purpose is pushing Chinese pharmaceutical and medical device industries to innovate It was replaced by the Drug Master Files (DMF) filing policy. completed the merger by absorption of Shanghai Union Biopharm (previously listed on the NEEQ, stock code: 430598. Eisai Co. The NMPA (CFDA) changes will offer both opportunities and challenges to many foreign companies targeting the Chinese market. CAIQTEST KOREA : http://www. While the two parties have adopted guidelines and outlined their goals for the continued talks, the specifics of how the UK and EU will interface on drug and device regulation post-Brexit are still being worked out. AREYOUOK. The NMPA has strict regulatory requirements, especially for foreign manufacturers who want to import their products to China. The predecessor to the NMPA was initially founded in 1998 to oversee drugs and medical devices. CFDA. , U. The National Medical Products Administration (NMPA), the new Chinese agency for regulating drugs and medical devices (formerly the China Food and Drug Administration or CFDA), will organise a training programme on "Regulatory Procedures for APIs and Formulations in China on 21st June 2019 at Shanghai in China. The main regulatory body is the National Medical Products Administration, also known as the NMPA (formerly the China Food and Drug Administration)[1] The Regulations Concerning the Hygiene Supervision over Cosmetics[2] Provides definitions of cosmetics and general rules on supervision of cosmetics Since end of 2017, the NMPA (formerly CFDA) launched the DMF system for APIs, excipients and pharmaceutical packaging materials. For medical devices under item (3) above, the CFDA will listen to opinions extensively and organize experts review to determine the approval. BeiGene, a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced that the China National Medical Products Administration (NMPA, formerly known as the CFDA) has granted priority review status to the supplemental new drug application (sNDA) for tislelizumab, an investigational Fc-engineered anti-PD-1 antibody, for patients with previously treated locally It is the first companion diagnostic kit approved by CFDA for the detection of the epidermal growth factor receptor (EGFR) gene mutations in circulating tumor DNA (ctDNA) derived from plasma. S. China's regulatory authority, the China Food and Drug Administration (CFDA) is now the National Medical Products Administration or NMPA. Early in the year 2018, the institutional reorganization launched by the State Council of China replaced the former CFDA (China Food and Drug Administration) by the NMPA (National Medical Product Administration), with a broader scope of actions: safety supervision, quality inspection, registration, certification HLX02 is a biosimilar developed by Henlius with independent intellectual property for the treatment of HER2 positive metastatic breastcancer (BC) and metastatic gastric cancer (GC). Similarly to the FDA in the United States, the NMPA classifies medical devices into three classes (from I to III) depending on their potential risk. Grace, a seasoned medtech executive, specializes in helping U. 7 hours ago · The China NMPA (formerly CFDA) accepted the Company's IND application for a Phase II trial for AlloJoin®, CBMG's "Off-the-Shelf" allogeneic haMPC therapy for the treatment of Knee Osteoarthritis Announcement of China NMPA on the Result of Medical Device Review and Sampling Inspection (2019, No. Shanghai Junshi Biosciences Co. Frequently raised questions and other practical major concerns regarding the requirements and procedures of the new online notification system were covered in the replies. cn)因技术维护需要,将从2019年10月7日起暂停访问,预计于2019年10月14日前恢复,给您带来的不便敬请谅解! NMPA, the successor to CFDA, is the single regulatory body responsible for registering medical devices including in vitro diagnostics, pharmaceuticals, and cosmetics in China. Cosmetics must be tested in NMPA-designated testing Institutions in China. Finally, last month, the NMPA published two of those documents in final form, “Implemented on April 19, 2019”. This marks CBMG's second clinical 1. Ministry of Commerce in respect of antitrust law enforcement. So, all CFDA and SFDA on this website default mean NMPA . Then last summer, a new government agency, the National Medical Products Administration (NMPA), posted three draft guidance documents for review and comments (see “China Posts New Draft Pharma Serialization Guidelines”). In the latest in a series of regulatory changes in China, the national drugs regulator has apparently been renamed the  The Chinese market for drugs and medical devices is increasing fast – and the CFDA (currently, National Medical Products Administration, NMPA) must ensure   提示:国家药品监督管理局网站(www. On December 28 th, 2018, National Medical Products Administration (NMPA) issued ‘ Administrative Regulations of Drug and Medical Device Overseas Inspection ’ (NMPA order No. 2018 wurde die neue offizielle Website von NMPA (National Medical Products Administration) vormals CFDA (China Food and Drug  7 Jan 2019 These recent scandals from July have further pushed the NMPA to accept overseas Tags: CFDA china drug life sciences NMPA vaccine  5 Dec 2018 China's NMPA(CFDA) has approved at least two AI diagnostic products and has just updated its medical device catalogue as of August 2018. Testing. Our experience in the Chinese generics market includes: China’s National Medical Products Administration (NMPA) officially announced that the registration of first-imported non-specials cosmetics has been replaced entirely by filing management nationwide. Companies that plan to introduce their devices to China are recommended to carefully review the New GMP and the GSP rules and timely address any potential discrepancy in their operations. BioPharma’s experienced scientific team includes members of Chinese origin with extensive in-country networks allowing for close communication with the NMPA – National Medical Products Administration (formerly CFDA – China Food and Drug Administration) and other key individuals in the Chinese market. org uses a Commercial suffix and it's server(s) are located in N/A with the IP number 67. Printer friendly On February 6, 2018, the China Food and Drug Administration (CFDA) and its Center for Medical Device Evaluation (CMDE) issued a draft guidance entitled “Guidance on the Review of Medical Devices for Preventing and Treating Rare Diseases. The domain nmpa. Our FDA QSR, NMPA (formerly CFDA), and ISO 13485 compliance, along with our well-maintained Class 7 & 8 Cleanrooms, and vertically integrated manufacturing capabilities, enable us to work lock-step with our customers to ensure production is flexible, scalable, and yields high performance results. cn)因技术维护需要,将从2019年10月7日起暂停访问,预计于2019年10月14日前恢复,给您带来的不便敬请谅解! CHINA: NMPA (formerly CFDA) has Released a List of Amended Medical Device Industry Standard in FY 2018 - September, 2018 September 17, 2018 The National Medical Product Administration (hereinafter referred to as NMPA) has released a list of medical device industry standards covering the new and amended standards from August 7 th . The China NMPA (formerly CFDA) accepted the Company's IND application for a Phase II trial for AlloJoin®, CBMG's "Off-the-Shelf" allogeneic haMPC therapy for the treatment of Knee Osteoarthritis (KOA), and has accepted the Company's IND application for a Phase II trial for ReJoin® autologous haMPC therapy for the treatment of KOA. 2、nmpaの方針と規制をすばやく把握でき、リスクを回避するための安全で効率的な申請ルートを提案する。 3、国内外の化粧品関連協会や公的機関と密接する。 4、中国語、日本語、英語の多言語対応。 三、nmpa申請フロー: 四、nmpa申請ルート: 2018年には中国cfda(現nmpa)が主催する『日本のgmp査察システムに関する検討会』にメンバーとして参加。 その他レギュレーション関連の関連記事 PMDA/承認申請時の電子データ関連の通知(2019年9月27日付) NMPA (previously known as CFDA) recently published its replies to some common questions regarding the cosmetics supervision and management in an update on its official website. CFDA)의 진행하는 어려움을 해결 해드리는 CAIQTEST 입니다. Deepening. As such, this article refers to the administration as “NMPA” throughout, regardless of whether the reference is to past, present, or future activities. CFDA (China-FDA) und NMPA (National Medical Product Administration) Im März 2018 wurde die staatliche Behörde für Marktzulassung ins Leben gerufen. com - China NMPA FDA,SFDA,CFDA,MOH,MOA,AQSIQ,CNCA,CIQ registration approval license for cosmetics,health food supplement,medical device,IVD,drug,infant milk According to the relevant provisions of the Regulation of the People's Republic of China on the Disclosure of Government Information, this annual report is prepared based on the actual information disclosure situation of the Center for Food and Drug Inspection of NMPA in 2018. The Council of Fashion Designers of America, Inc. CFDA of China is now, NMPA On August 29, 2018 the State Food and Drug Administration of China has released a notice stating that it’s official English name - China Food and Drug Administration (CFDA) has been changed to National Medical Product Administration (NMPA). More Information. 12, 2018 /PRNewswire/ -- Innovent Biologics, Inc. CDE is defined as Centre of Drug Evaluation (Drug Administration Law of SFDA of China) very rarely. The legal entity could be your importer, subsidiary, or a third party. 28 Aug 2019 The Rules for Unique Device Identification System in China is issued by the NMPA/CFDA on August 23rd, 2019 and effective from October 1st,  2018年9月3日 29日下午,原国家食品药品监督管理总局网站发布的消息显示,药品注册报盘软件中 所涉及“CFDA”英文简称变更为“NMPA”,其全称不出意外的话便  Get an overview of the CFDA application process for medical devices and the 17th, 2018, the CFDA was replaced by the NMPA (National Medical Products  2018年9月3日 醫藥網9月3日訊一則“藥品註冊申請表新版程序2018年9月1日啟用”的通知,揭示了 國家藥品監督管理局英文簡稱由"CFDA"變為"NMPA"。 Kick off meeting: Sept 2016, participated by PSM member associations and CFDA (now NMPA). (CFDA) is a not-for-profit trade association of America’s foremost fashion and accessory designers. Our GMP API and drug product manufacturing facility is qualified for manufacturing GMP API and drug product to support clinical trials worldwide. With ISO 13485 certified facilities that are also FDA and NMPA (formerly CFDA) registered, we are well equipped to manufacture Class I & II mechanical and electro-mechanical medical devices in our Class 7 and Class 8 Cleanrooms. Source: CFDA and China Medical Science and Technology Network Note: Content may be edited for style and length On 14th December 2017, The Chinese State Food and Drug Administration (CFDA) issued 2 announcements and has decided to suspend imports of HER-2 detection kits (immunohistochemistry) produced by Leica Biosystems Newcastle Ltd, UK and calcium sulphate and… The approval of the IND by the Center For Drug Evaluation of the China National Medical Products Administration (“NMPA”, formerly the CFDA) of the oral insulin paves the way for the start of clinical trials in China. Regulatory Reform. > CFDA issues the Announcement of Banning the > China adopts tough law to ensure vaccine safety 2019-07-18 > Center for Food and Drug Inspection of NMPA 20 提示:国家药品监督管理局网站(www. Currently, a company can only run a Phase I trial in China for a product that has already been tested in humans in other countries. MHRA, CFDA Sign MoU on Drug, Device Regulation. In July 2015 and January 2016, HLX02 was approved by the CFDA (now China NMPA ) for IND in patients with BC and GC successively. Doc. CFDA’s current plan is to inspect 300 to 400 pharmaceutical manufacturers every year in China, and 40 to 60 imported drug manufacturers outside China. In 2015, China’s regulatory body began its reformation process which has led to its name change (from CFDA to NMPA) as well as other changes involving registration, review, communication, and many others. government agencies to the American public. Article 1 These Regulations are hereby formulated with a view to strengthening the supervision and administration of medical devices, ensuring their safety and effectiveness and protecting human health and life safety. com - China NMPA FDA,SFDA,CFDA,MOH,MOA,AQSIQ,CNCA,CIQ registration approval license for cosmetics,health food supplement,medical device,IVD,drug,infant milk 재중책임회사는 cfda제출서류에 대한 책임만 지면 되었지만 (돌려말해 누구나 돈만 주면 선임이 가능했습니다) 경내 책임자로 제도가 변경되면서 경내책임자는 China’s New State Market Regulatory Administration: What to Know and What to Expect. HLX02 is a biosimilar developed by Henlius with independent intellectual property for the treatment of HER2 positive metastatic breastcancer (BC) and metastatic gastric cancer (GC). Updated fee structure. 新名新气象? 8月29日,国家食品药品监督   Medical devices are regulated by the National Medical Product Administration ( NMPA), formerly the China Food and Drug Administration or CFDA. NMPA(구. In 2016, CFDA published new regulation of pharmaceutical excipients based on China DMF filing, and final product associated approval system. Chapter I General Provisions. The clinical trial application review and approval or filing process is determined by the drug category in which an applicant chooses to register. •. This marks CBMG's second clinical CFDA MEDICAL & PERSONAL CARE. Cfdachina. The National Medical Products Administration (NMPA) is the Chinese agency for regulating drugs and medical devices (formerly the China Food and Drug Administration or CFDA). COM is a media platform dedicated to providing the hottest news, data service and analysis on the latest health tech disruptions of Asian markets. NMPA now falls under the State Administration for Market Regulation (SAMR), a newly established agency at the ministry level, and no longer reports directly to the State Council. , known as MSD outside of the United States and Canada, announced that the China National Medical Products Administration (NMPA) approved the kinase inhibitor LENVIMA (lenvatinib) as a single agent for the treatment of patients with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy. 13 in 2018, Issued on Jan. Ein Teil derer ist die NMPA (National Medical Product Administration). Pharmaron’s quality system has passed numerous quality audits from big pharma and biotech companies and is in compliance with regulatory requirements. SUZHOU, China, Nov. The National Medical Products Administration (NMPA) (the Chinese name translates as “State Drug Administration”) is the regulatory authority responsible for clinical trial oversight, approval, and inspections for drugs to be registered in China. , known as MSD outside of the United States and Canada, announced that the China National Medical Products Administration (NMPA According to NMPA regulations, foreign manufacturers of pharmaceutical packaging and ingredients shall appoint a NMPA Legal Agent for product registration. CFDA Name Change China Food and Drug Administration (CFDA) has officially changed its English name to National Medical Product Administration (NMPA). ) China NMPA ( former CFDA ) recently announced that the implementation of Electronic Regulated Product Submission system (e-RPS) will come into effect on June 24, 2019. China National Medical Products Administration (NMPA) Email: wangsc@nmpa. (CFDA) / National Medical Products Administration (NMPA) present opportunities in China like never before. For medical device under item (1) and (2) above, the applicant would have to submit the application for priority examination and approval to the CFDA. The NMPA grants permission for clinical trials to be conducted in China in  9 Jan 2019 The National Medical Products Administration (NMPA), previously the China Food and Drug Administration (CFDA), is the institution  1 Sep 2018 Bye Bye CFDA - Welcome NMPA. “restricted” and “promoted” categories of generic drugs, which signals a move toward more  7 Jul 2019 today announced that the China National Medical Products Administration ( NMPA, formerly known as the CFDA) has granted priority review  National Medical Products Administration (NMPA) (formerly CFDA) and Centre for Medical Device Evaluation (CMDE) is responsible for the review of the  2018年9月3日 一则“药品注册申请表新版程序2018年9月1日启用”的通知,揭示了国家药品监督 管理局英文简称由"CFDA"变为"NMPA"。 最新简称“NMPA”的全称  2019年4月29日 长桑技术通过采集脉搏容积波信号的方式计算人体血压等参数的模型。 7 Jul 2019 today announced that the China National Medical Products Administration ( NMPA, formerly known as the CFDA) has granted priority review  15 Mar 2019 Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA: simplified Chinese: 国家食品药品监督管理局). IBI303 is a recombinant human anti-TNF-α monoclonal antibody independently developed by Innovent for the treatment of China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), announced on 22 February 2019 that it had approved Hanlikon, a rituximab copy biological. It lists four main considerations for the registration of AI-Aided Software, Needs analysis, Data collection, Algorithm design and verification and validation. - Expert of China NMPA FDA,SFDA,CFDA,MOH,MOA, AQSIQ,CNCA,CIQ registration approval license for cosmetics,health food  21 Jun 2019 NMPA (CFDA) published 2018 Medical Device Registration Report on May 31. This marks CBMG's second clinical NMPA - National Motorsports Press Association 206 were donated in July This month, we are on track to donate 208 home recent additions webmaster page banners feed a child The latest Tweets from CFDA (@CFDA). China Post Market Compliance and the mandatory reporting. As of September 1st 2018 the new name of the organization responsible for Medical devices in China is  NMPA Releases Draft Good Manufacturing Practice Appendix on Standalone CFDA Issues Groundbreaking Proposals for Medical Device Regulatory Reform. China NMPA (CFDA): Recent Developments in China Medical and IVD Devices: MAH/Legal Agents and the Implications in local manufacturing and product registration. The China Food & Drug Administration (CFDA) is responsible for medical devices, drugs, and healthcare services. Our commercialization services include: market assessment research, reimbursement, partnership strategies, and distribution qualification. Both domestic and imported cosmetic products require pre-market approval or notification before they can be placed on Chinese market. Note: The national drug administration of China, formerly known as the China Food and Drug Administration (CFDA), recently changed its English name to the National Medical Products Administration (NMPA). In China, Medical Devices (MDD) and In Vitro Diagnostic (IVD) reagents are regulated by following laws: Any Medical Device or In Vitro Diagnostic reagents manufacturer seeking to market their product in China must apply for and acquire the Medical Device Registration Certificate from China Food and Drug Administration (CFDA). 2013年国家食品药品监督管理总局更名为cfda,前身是sfda The National Medical Products Administration (NMPA) (Chinese: 国家药品监督 管理局) (formerly the China Food and Drug Administration, or CFDA) was founded  The National Medical Products Administration (NMPA) is the Chinese agency and medical devices (formerly the China Food and Drug Administration or CFDA) . NMPA administration and its directly affiliated units in Beijing. 30) 2019-07-08; Admin; 0 Comments; In the effort to strengthen the review quality of medical device and improve the safety and effective use of medical device products, China NMPA carried out the sampling inspection on 877 batches range from 15 product categories: alanine aminotransferase assay Subject: UNIQUE OPPORTUNITY: Training programme on "Regulatory Procedures for APIs and Formulations in China "by National Medical Products Administration (NMPA) on 21 st June 2019 at Shanghai, China Member companies are aware, China is an important market for Indian pharma and recently there were many changes in the regulatory systems of China, primarily transforming from CFDA to NMPA. 12/2 rev2, PMCF (Post market clinical follow-up) studies EN IEC62304 Software lifecycle process for medical devices “After navigating the NMPA’s regulatory changes, recently required product modifications, and product approval process, we look forward to resuming sales of our Alpha products into China. CFDA also changed the name to the National Medical Products Administration (NMPA). cn The National Medical Product Administration (NMPA), a vice-ministerial level body under the State Administration for Market Regulation (SAMR), is responsible for creating and supervising the implementation of policies, plans and standards governing the quality and safety of drugs, cosmetics, and medical devices. BeiGene, a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced that the China National Medical Products Administration (NMPA, formerly known as the CFDA) has granted priority review status to the supplemental new drug application (sNDA) for tislelizumab, an investigational Fc-engineered anti-PD-1 antibody, for patients with previously treated locally CFDA: CFDA Issues Technical Guideline for Clinical Evaluation of Medical Devices. CHINA: NMPA (formerly CFDA) has Released a List of Amended Medical Device Industry Standard in FY 2018 - September, 2018 September 17, 2018 The National Medical Product Administration (hereinafter referred to as NMPA) has released a list of medical device industry standards covering the new and amended standards from August 7 th . The CFDA is separated into various departments that are individually responsible for the registration, tracking, and monitoring of medical devices and drug. (Source: cnzqxx. 650 2014)-main regulation BeiGene, a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced that the China National Medical Products Administration (NMPA, formerly known as the CFDA) has granted priority review status to the supplemental new drug application (sNDA) for tislelizumab, an The China NMPA (formerly CFDA) accepted the Company's IND application for a Phase II trial for AlloJoin®, CBMG's "Off-the-Shelf" allogenic haMPC therapy for the treatment of Knee Osteoarthritis (KOA), and has accepted the Company's IND application for a Phase II trial for ReJoin® autologous haMPC therapy for the treatment of KOA. Provide you with medical device registration, cosmetic registration, industry regulation spreading and training, quality system, project incubation, SMO services, CRO and clinical evaluation services. Similar Topics The National Medical Products Administration (NMPA) is the Chinese agency for regulating drugs and medical devices (formerly the China Food and Drug Administration or CFDA). The new system will accelerate the use of GMP-manufactured excipients in both NDA and ANDA, also in quality and therapeuticaleffects Beijing Alan specializes in obtaining the Sanitary License for a wide range of cosmetic products. Products you may be interested in Synmax Fermentation Services (CRO/OEM/ODM) China NMPA issued the Rules for Unique Device Identification System on August 23rd, 2019 List of Innovative Devices Approved to Enter Green Channel Registration (Continuously updated) List of Prioritized Devices Approved to Enter Green Channel Registration (Continuously updated) 监督管理局(nmpa,前身为cfda)已受理abraxane®注射用紫杉醇(纳米蛋白 颗粒结合型)联合吉西他滨用于治疗一线转移性胰腺癌(mpc)患者的进口药品新适 应症上市申请。abraxane 于2008 年在中国首次获批用于治疗转移性乳腺癌患者。 因报盘软件中所涉及"cfda"英文简称变更为"nmpa",自2018年9月1日起,请药品注册申报单位及时下载药品注册新版报盘程序进行填报。 各申请单位使用时如有问题,请拨打电话010-88330526反馈意见,并随时关注更新情况,每次更新会标注具体更新日期。 he National Medical Products Administration (NMPA) (formerly the CFDA) has clearly focused on quality as its primary objective over the past few years. 2018-08-30 16:00. 监督管理局(nmpa,前身为cfda)已受理abraxane®注射用紫杉醇(纳米蛋白 颗粒结合型)联合吉西他滨用于治疗一线转移性胰腺癌(mpc)患者的进口药品新适 应症上市申请。abraxane 于2008 年在中国首次获批用于治疗转移性乳腺癌患者。 The National Medical Products Administration (NMPA), the new Chinese agency for regulating drugs and medical devices (formerly the China Food and Drug Administration or CFDA), will organise a training programme on "Regulatory Procedures for APIs and Formulations in China on 21st June 2019 at Shanghai in China. The UK's Medicines and Healthcare products Regulatory Agency (MHRA) and the China Food and Drug Administration (CFDA) on Wednesday signed a memorandum of understanding (MoU) to exchange information on new areas of drug and medical device regulation. If so, you need to register your device with China's regulatory authority, the China Food and Drug Administration (CFDA), now the National Medical Products Administration or NMPA. With a view to create awareness on the recent developments on the product registration guidelines and dossier filing with The National Medical Products Administration(NMPA -formerly CFDA) Pharmexcil is organizing a full day workshop in association with M/s. Regulations for the Supervision and Administration of Medical Devices. China RJS MedTech Inc. In addition, blood products and vaccine manufacturers will be inspected every year, according to Wang. The National Medical Products Administration (NMPA) (Chinese: 国家药品监督管理局) (formerly the China Food and Drug Administration, or CFDA) was founded on the basis of the former State Food and Drug Administration (SFDA). The China Food and Drug Administration (CFDA) has detailed the data management standards it expects companies to follow when researching, developing, making, distributing and monitoring the use of medicines. NMPA (CFDA) New Medical Device Classification Catalogue Effective August 1st, 2018 Six changes you must know #China #NMPA  20. CFDA Administration Service Announced CFDA is now NMPA In an notice CFDA administration department issued, it announced CFDA abbreviation is to be changed into MNPA. The original text is translated below as: “Considering the English abbreviation of ‘CFDA’ involved in the offer software has been changed to ‘NMPA’, since September 1, 2018, the drug […] The China Food and Drug Administration (CFDA) (now NMPA) is the administrative body responsible for the regulation of medical devices and pharmaceuticals on the Chinese mainland. Hello, Since CFDA's website upgrade to new NMPA structure, all download links have disappeared. USA FDA, Japan MHLW, China CFDA (NMPA) Medical Device registration and other countries medical device requirements MEDDEV 2. 101 2018) implemented from the date of publication. 2018年8月30日 据CFDA行政事项受理服务中心8月29日发布的最新文件显示,总局英文简称“CFDA” 或已变更为“NMPA”。 China DMF filing for Pharmaceutical Excipients According to the new CFDA regulations, “Announcement of the CFDA on Adjusting Matters Concerning the  2019年1月21日 因报盘软件中所涉及"CFDA"英文简称变更为"NMPA",自2018年9月1日起,请药品 注册申报单位及时下载药品注册新版报盘程序进行填报。各申请  Wang Shucai Deputy director general. The China NMPA (formerly CFDA) accepted the Company's IND application for a Phase II trial for AlloJoin®, CBMG's "Off-the-Shelf" allogenic haMPC therapy for the treatment of Knee Osteoarthritis (KOA), and has accepted the Company's IND application for a Phase II trial for ReJoin® autologous haMPC therapy for the treatment of KOA. com - China NMPA FDA,SFDA,CFDA,MOH,MOA,AQSIQ,CNCA,CIQ registration approval license for cosmetics,health food supplement,medical device,IVD,drug,infant milk The National Medical Product Administration (NMPA), a vice-ministerial level body under the State Administration for Market Regulation (SAMR), is responsible for creating and supervising the implementation of policies, plans and standards governing the quality and safety of drugs, cosmetics, and medical devices. 8月29日,行政事项受理服务大厅发布《药品注册申请表新版报盘程序2018年9月1日启用(2018年8月29日更新)》,文件称"CFDA"英文简称变更为"NMPA(National Medical Products Administration)",揭开了国家药品监督管理局英文名称及缩写的 The National Medical Products Administration (NMPA) (Chinese: 国家药品监督管理局) (formerly the China Food and Drug Administration, or CFDA) was founded on the basis of the former State Food and Drug Administration (SFDA). 650 The Regulations on Supervisory Management of Medical Devices have been revised and approved at the 39th Executive Meeting of the State Council on February 12, 2014. HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today China will accept foreign clinical trial data. com/main. I am searching for the official and latest documents from institutionnal sites: NMPA, CFDA nmpa. China: CFDA releases draft drug data management practices for consultation (Source: RAPS 2017-08-31) The China Food and Drug Administration (CFDA) has detailed the data management standards it expects companies to follow when researching, developing, making, distributing and monitoring the use of medicines. The agreement also comes as the UK and EU prepare to enter the next round of Brexit negotiations. The Notice reduces burdensome requirements in the application process for domestic and foreign manufacturers when renewing or making changes to an existing medical device license in China. The draft amendment is expected to be promulgated later this year. The organization is headquartered in Beijing, with offices in each province. Understanding NMPA is CRUCIAL for medical device companies planning to expand to the Chinese market. org reaches roughly 3,967 users per day and delivers about 119,016 users each month. For this, the NMPA demands comprehensive documentation from all its applicants. For example, to protect data integrity and quality, China launched its self-inspection initiative in July 2015. ince China joined ICH in 2017, the National Medical Products Administration (NMPA, the former CFDA) has gradually aligned local regulatory guidelines and requirement for submission dossiers with global guidelines and requirements, and has urged pharmaceutical companies to correspondingly adjust their document preparation and submission strategies in a timely manner. Novartis’ Cosentyx (secukinumab) Receives NMPA’s (CFDA) Approval for Patients with Plaque Psoriasis in Adults qcac-そのビジネスフィールドは、中国国家政府や各省政府の人脈を活かし、知的財産保護、ビジネスセキュリティ、及び日中投資総合コンサルティング業務まで幅広く展開しています。 因报盘软件中所涉及"cfda"英文简称变更为"nmpa",自2018年9月1日起,请药品注册申报单位及时下载药品注册新版报盘程序进行填报。 各申请单位使用时如有问题,请拨打电话010-88330526反馈意见,并随时关注更新情况,每次更新会标注具体更新日期。 The CFDA has also stated that companies should expect to pay the full cost of the review process, which had until the announcement been effectively resourced by taxpayer revenue. The SDA will be led by Communist Party Secretary Li Li 16 (formerly deputy governor of Jiangxi Province), and Director Hong Jiao 17 (formerly Deputy Director of the CFDA). NMPA is an organization under the "State Administration for Market Regulation" (SAMR) that was found in March 2018 integrating the former: State Administration for industry and commerce of the PRC (SAIC) General Administration of Quality Supervision, Inspection and Quarantine of the PRC (AQSIQ) China Food and Drug Administration (CFDA) The Rules for Unique Device Identification System in China is issued by the NMPA/CFDA on August 23rd, 2019 and effective from October 1 st, 2019. 2018年9月3日 大陸媒體對於新的英文簡稱感受頗多,一路由SDA、CDA、SFDA、CFDA再到現在的 NMPA,似乎也代表著中國食藥監督的不斷演進。雖是不太熟悉的  9 Oct 2018 NMPA will be responsible for: The responsibilities of China Food and Drug Administration (“CFDA”) are split into two new departments: the  It was previously known as the China Food and Drug Administration (CFDA). That means, foreign manufacturers who export products to China do not need to apply for the Imported Pharmaceutical Excipients License (IDEL) any longer, but will need to take different action (see below). NMPA issued the Announcement on Issues Concerning the Further Improvement of Drug-related Associated Review &Approval and Supervision. Its remit may be expanded to include medical-related artificial intelligence. Provide you with medical device registration, cosmetic registration, industry regulation spreading and training, quality system, project incubation, SMO In May 2017, the China Food and Drug Administration (CFDA) published a draft list of Class II & III Medical Devices that are exempt from clinical trial requirements. And now - their expertise is available to you. Read the latest straight from NMPA President & CEO David Israelite on the state of the publishing industry, the difficulties songwriters face and what must be done to help creators survive in the Digital Age. nmpa cfda

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