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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
REGULATION
Laws & Regulations
New Rules for Medical Device Registration and Filing in China On Aug. 26, China State Administration for Market Regulation released Administrative Measures for Medical Device Registration and Filing, which is set to take effect on Oct. 1, 2021.
Sep 18, 2021
REGULATION
Laws & Regulations CDE Guidance
Monthly Recap: China Pharmaceutical Regulatory Updates | July 2021 1. NMPA releases the 43rd batch of reference listed drugs; 2. NMPA announces nine Rx-to-OTC switches; 3. NMPA and CNIPA rolls out measures for resolving drug patent disputes...
Aug 24, 2021
REGULATION
Laws & Regulations Marketing Approval Innovative Drugs Generic Drugs
China Rolls Out Measures to Establish Drug Patent Linkage System China tries to balance the patent protection of innovative drugs and the development of generics. MAHs of innovative drugs can bring a lawsuit or apply for an administrative ruling to protect patents. The first generics that successfully challenge the registered innovative drugs can enjoy 12-month marketing exclusivity.
Jul 23, 2021
REGULATION
Laws & Regulations CDE Guidance Biological Products
Monthly Recap: China Pharmaceutical Regulatory Updates | June 2021 The monthly recap is intended to bring you the dynamics of recent major laws and regulations issued by China drug regulators, including National Medical Products Administration (NMPA) and the Center for Drug Evaluation (CDE).
Jul 20, 2021
REGULATION
Laws & Regulations
Monthly Recap: China Pharmaceutical Regulatory Updates | May 2021 The monthly recap is intended to bring you recent major laws and regulations issued by China drug regulators.
Jun 18, 2021
REGULATION
Laws & Regulations GMP
China Takes New Measures for GMP & GSP Inspection China has cancelled the GMP and GSP certification since it implemented Drug Administration Law in 2019. Now, the drug manufacturing and supply activities in the country will be inspected according to Administrative Measures on Drug Inspection (Trial).
Jun 15, 2021
REGULATION
Laws & Regulations Pharmacovigilance
China Implements the Newly Released Good Pharmacovigilance Practice The Chinese GVP applies to Marketing Authorization Holders’s pharmacovigilance activities about medicinal products and drug registration applicants with authorization to carry out clinical trials.
May 28, 2021
REGULATION
Laws & Regulations CDE Guidance
Monthly Recap: China Pharmaceutical Regulatory Updates | April 2021 In Apr. 2021, China National Medical Products Administration (NMPA) and its subordinate body Center for Drug Evaluations (CDE) published a series of regulations on medical products, including pediatric medicine and biosimilars.
May 12, 2021
REGULATION
Laws & Regulations CDE Guidance Reference Listed Drug (RLD) CMC Clinical Trials Generic Drugs APIs
Monthly Recap: China Pharmaceutical Regulatory Updates | March 2021 In Mar. 2021, the Center for Drug Evaluation released a total of seven announcements including contents such as technical requirements for drug research & evaluation. ChemLinked BaiPharm team collected the documents and summarized their keynotes.
Apr 08, 2021
INDUSTRY
Laws & Regulations Post-market
Adverse Drug Reaction in China: Important Numbers from 2020 Report In 2020, China's National Monitoring System of Adverse Drug Reaction (ADR) received a total number of 1.676 million reports of ADR events.
Mar 31, 2021
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