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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
INDUSTRY
Law & Regulation 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
POLICY
Law & Regulation Marketing Approval Priority Review and Approval
Drugs Marketed in Hong Kong Are Expected to Supply Patients Across the Greater Bay Area Soon Patients in the Greater Bay Area can soon have access to the marketed drugs in Hong Kong's public hospitals.
Mar 29, 2021
REGULATION
Law & Regulation
China Launches Medical Device Master File System On Mar. 12, 2021, China National Medical Products Administration (NMPA) announced guidance on filing medical device master files (MAFs), which specified content, format and procedures of this new MAF system. The announcement took effect on the same day.
Mar 26, 2021
POLICY
Priority Review and Approval Generic Drug
China Releases Second Batch of 17 Encouraged Generic Drugs China officially issued the Second Batch of 17 Encouraged Generic Drugs, which could benefit from preferential policy support in terms of priority review and approval, clinical trials and critical generic technology researches in China.
Mar 26, 2021
REGULATION
Clinical Trial CRO GCP
China Rejects Medical Device Registration Applications with Data Authenticity Issues On Jan. 15, 2021, China National Medical Products Administration rejected a company’s medical device registration application because of the data authenticity issue in the clinical trial.
Mar 24, 2021
INDUSTRY
Law & Regulation Marketing Approval Innovative Drug
Ophthalmic Drug Market in China Attracts Increasing Attention In recent years, incidence rates of diseases like myopia, cataract, and dry eye syndrome have been growing year by year for all age groups in China.
Mar 22, 2021
REGULATION
CDE Guideline MAH GMP
China Releases Guidance for Declaration of Chemical Drug Changes On Feb. 10, 2021, China Center for Drug Evaluation issued and started implementing the Guidance for Acceptance and Review of Chemical Drug Changes (Trial). The document addresses supplemental applications that entail the reviews of state-level drug regulatory authorities, including those submitted during clinical trials.
Mar 19, 2021
POLICY
Law & Regulation Volume-Based Procurement Medical Insurance
China's 2021 Two Sessions: What Can We Expect for the Medical and Health Sectors? Chinese Premier Li Keqiang pointed out nine major objectives in the medical and health sectors in 2021 in the Government Work Report on March 5th.
Mar 15, 2021
REGULATION
Law & Regulation CDE Guideline Marketing Approval CMC Generic Drug API
China Announces Technical Requirements for Overseas Approved Chemical Drugs Seeking Domestic Marketing Authorization On Mar. 8, China Center of Drug Evaluation issued the Technical Requirements for CMC Studies and Evaluation of Overseas-approved Chemical Drugs without Domestic Marketing Authorization (Trial).
Mar 09, 2021
POLICY
Volume-Based Procurement Diabetes
China to Carry out National Insulin Procurement China will pilot a nationwide insulin procurement which may refer to the previous pilot insulin procurement scheme in Wuhan. It means the price of insulin products will be significantly reduced, and the market share of relevant pharmaceutical companies in China will be affected.
Mar 08, 2021
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