Recently, the Crovalimab Injection (trade name: 派圣凯/Piasky) of Roche Pharma (Schweiz) AG was approved for marketing by China NMPA through the priority review ...
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Reagents for Detection of Influenza A Viruses Approved by China NMPA · Rules for Labels of Prepared Slices of Chinese Crude Drugs Issued by China NMPA · ad1.jpg ...
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Chinese Vaccine Manufacturers · 2.jpg List of Approved Domestic Vaccine Products in China · 3.jpg Certificate of a Pharmaceutical Product · About NMPA.
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Our Responsibilities · To supervise the safety of drugs (including traditional Chinese medicines (TCMs) and ethno-medicines, the same below), medical devices and ...
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People also ask
How to get a drug approved in China?
The NMPA reviews the NDA, following which it conducts an on-site inspection of the applicant's manufacturing facilities. The NMPA may also request additional clinical data or other relevant information from the applicant. If the NMPA is satisfied with the NDA, it will approve the drug for sale in China.
How to register a medical device in China?
The Chinese NMPA medical device approval process explained
Appoint an agent located in China to manage your device registration and interact with the NMPA on your behalf. Demonstrate proof of home country approval using documentation such as a Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG).
What is China FDA called?
Drugs and medical devices are overseen by the former China Food and Drug Administration (CFDA) now the National Medical Products Administration (NMPA), which reports to the State Administration of Market Regulation (SAMR).
What is the regulatory agency for drugs in China?
China's Health Authority:
In China, Pharmaceuticals are regulated by The National Medical Products Administration (NMPA) is the Chinese agency for regulating drugs and medical devices (formerly known as the China Food and Drug Administration or CFDA).
Jun 30, 2020 · The registration classification of chemical drugs covers innovative drugs, modified new drugs, generic drugs and chemical drugs marketed ...
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Jul 19, 2019 · Main responsibilities. (1) Be responsible for the acceptance and technical review of applications for drug clinical trials and drug ...
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Jul 25, 2019 · The Provisions are formulated for the purposes of ensuring the safety, efficacy and quality of drugs and regulating drug registration in ...
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Jul 19, 2019 · Organize the sampling and testing, and quality analysis of drugs, medical devices and cosmetics. Be responsible for relevant re-evaluation and ...
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Provisions for Supervision and Administration of Online Drug Sales. 2022-12-29.
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Jul 25, 2019 · Article 16: The manufacturer should establish a management structure and have an organization chart. The quality management department should be ...
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