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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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 of 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
POLICY
Laws & Regulations 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
Laws & Regulations
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
INDUSTRY
Laws & Regulations Marketing approval Innovative Drugs
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
POLICY
Laws & Regulations Centralized 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
Laws & Regulations CDE Guidance Marketing approval CMC Generic Drugs APIs
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
REGULATION
Laws & Regulations Marketing approval Clinical Trials Priority Review and Approval
China CDE to Disclose New Drugs' Technical Review Reports China's Center of Drug Evaluation (CDE) recently announced that it would disclose the technical review reports and package inserts of all new drugs approved since Sept. 1, 2016. The disclosure would also extend to generic drugs and other applications in the future.
Feb 24, 2021
REGULATION
Laws & Regulations MAH Pharmacovigilance Post-market
China Requires Drug Market Authorization Holders to Submit Annual Report On Dec. 10, 2020, the National Medical Products Administration (NMPA) published the drafts of Administrative Provisions of Annual Drug Reports and Template for the Annual Drug Report, asking for public consultation before Dec. 22, 2020.
Dec 11, 2020
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