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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
REGULATION
Law & Regulation Reference Listed Drug (RLD) Bioequivalence (BE) Generic Drug
China May Delist Ineligible Reference Listed Drugs (RLDs) of Chemical Generic Drugs On Mar. 24, 2023, China NMPA released the Procedures for Adjusting Reference Listed Drugs (RLDs) of Chemical Generic Drugs (Trial) with immediate effect. RLDs are reference drugs to which generic drugs should be equivalent in safety and efficacy. NMPA finds that some listed RLDs no longer meet the Chinese Pharmacopoeia standards or the current technological requirements. That’s why NMPA formulates and implements the RLD Adjustment Procedures.
Mar 28, 2023
REGULATION
Law & Regulation Guideline Marketing Approval Priority Review NRDL Health Insurance Rare Disease Drug Registration Real World Data
The 16th Rare Disease Day: China's Efforts to Make Orphan Drugs Available and Affordable This year’s Feb. 28 marks the 16th International Rare Disease Day. In China, there are around 20 million rare disease patients, with more than 200,000 additional patients each year. China has shown a supportive attitude towards rare disease drug development in a series of official documents. The regulations and policies introduced in this article are significant in terms of the drugs’ marketing authorization review timeline and pricing.
Mar 10, 2023
REGULATION
Law & Regulation Guideline Pharmacopoeia
BaiPharm Regulatory Database Is Online: A Useful Tool to Search for China’s Pharma Guidelines, Regulations, and Standards ChemLinked BaiPharm Regulatory Database is a useful tool for ChemLinked users, especially overseas pharmaceutical companies that aim for China market, to search for China’s official guidelines, regulations, and Chinese Pharmacopoeia standards.
Feb 16, 2023
REGULATION
Law & Regulation Guideline Pharmacopoeia Reference Listed Drug (RLD) Marketing Approval NRDL Drug Registration COVID-19 GLP
Monthly Recap: China Pharmaceutical Regulatory Updates | January 2023 Check out the regulatory updates in Jan. 2023: 1. China Issues the 2022 National Reimbursement Drug List; 2. China Approves Two Homegrown Drugs for COVID-19; 3. China Releases Two Lists of RLDs; 4. China Issues GLP Certification Regulation; 5. China Rolls Out Pharmaceutical Guidelines; 6. Chinese Pharmacopoeia Commission Issues Drafts of Standards
Feb 06, 2023
REGULATION
Law & Regulation Pharmacovigilance Marketing Approval Volume-based Procurement Generic Drug Drug Registration E-commerce
2022 Recap: Top 10 BaiPharm Stories on China Pharmaceutical Regulations ChemLinked BaiPharm Portal has been tracking and interpreting China’s pharmaceutical regulations during the year of 2022. Here are the top 10 stories we selected for you to grasp China’s regulatory dynamics.
Jan 13, 2023
REGULATION
Law & Regulation Guideline Pharmacopoeia MAH Pharmacovigilance Clinical Trial Drug Registration
Monthly Recap: China Pharmaceutical Regulatory Updates | December 2022 Check out China's pharmaceutical regulatory updates in December 2022: 1. China NMPA Adds OTC Status to a Former Prescription Drug; 2. China NMPA Releases the 62nd List of RLDs; 3. China NMPA Issues Regulation on Supervising MAH as the Main Responsible Entity for Drug Safety; 4. China NMPA Requires Licenses for Importing and Exporting Anesthetics and Psychoactive Drugs; 5. China CDE Specifies Requirements for Electronic Submission of Drug Applications...
Jan 09, 2023
REGULATION
Law & Regulation Post-market E-commerce GSP
China's GSP Permits Drug Retailers to Entrust Delivery to Third Party from Jan. 1, 2023 It is the first time that China has clearly permitted online retailers to entrust drug delivery services to a third party.
Jan 01, 2023
REGULATION
Law & Regulation Drug Registration
China Requires Electronic Submission of All Drug Registration Application Documents from Jan. 1, 2023 China NMPA requires that all documents for drug registration applications, as well as supplemental documents sent during the review, shall be submitted electronically in compact disks with no paper required, from Jan. 1, 2023.
Jan 01, 2023
REGULATION
Law & Regulation MAH GMP Pharmacovigilance Clinical Trial Post-market Drug Registration GSP
China Issues Draft Regulation on MAH as Main Responsibility Entity for Drug Quality Drug marketing authorization holders (MAH) in China are required to establish drug quality management system and be responsible for the safety, effectiveness, and quality controllability during drug development, manufacture, supply, and use according to the Drug Administration Law, Good Manufacturing Practices (GMP), Good Supply Practices (GSP), Good Pharmacovigilance Practices (GVP), and relevant regulations.
Dec 16, 2022
REGULATION
Law & Regulation E-commerce
China Requires Online Drug Sellers and E-commerce Platforms to File Necessary Information On Nov. 31, 2022, China National Medical Products Administration specified the requirements for online drug sellers and online drug transaction platforms to file necessary information to local regulators.
Dec 14, 2022
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