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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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 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 MAH Pharmacovigilance Post-market
Drug Recall in China: MAHs Shall Shoulder the Main Responsibility China NMPA's new Administrative Measures for Drug Recall will take effect on Nov. 1, 2022. Different from the previous 2007 version, the new Measures designates drug marketing authorization holders (MAHs), instead of manufacturers, as the main responsible entity for drug recall.
Oct 31, 2022
REGULATION
Pharmacovigilance UK
UK Changes SUSAR Reporting for IMPs The eSUSAR website used for the submission of SUSAR reports to the MHRA will be decommissioned at the end of September and only SUSARs via the ICSR Submissions portal will then be accepted.
Aug 16, 2022
REGULATION
Law & Regulation Pharmacovigilance Post-market
China Releases MedDRA Coding Guidance for Adverse Drug Reaction (ADR) Reports MedDRA is a standardized medical terminology developed by the ICH. China's Guidance is for MAHs to use MedDRA coded terms in post-marketing adverse reaction reports.
May 18, 2022
REGULATION
Law & Regulation MAH Pharmacovigilance Marketing Approval Priority Review Health Insurance Innovative Drug Generic Drug Rare Disease Drug Registration New Drug
China Encourages Innovative Drug R&D in Revised Draft of Regulations for Implementing the Drug Administration Law Find out the highlights in revised draft of the Regulations for Implementation of the Drug Administration Law: pharmaceutical innovation, acceptance of foreign clinical data, support the development of pediatric and rare disease drugs...
May 13, 2022
REGULATION
Law & Regulation Guideline Reference Listed Drug (RLD) MAH Pharmacovigilance Marketing Approval CMC Bioequivalence (BE) Post-market Generic Drug Biosimilar Cancer New Drug
Monthly Recap: China Pharmaceutical Regulatory Updates | April 2022 Check out China's pharmaceutical regulation updates April 2022: China NMPA releases Pharmacovigilance Inspection Guidelines...
May 05, 2022
REGULATION
Law & Regulation Pharmacovigilance Post-market
Key Points for China Pharmacovigilance Inspections Marketing authorization holders that entrust the manufacturing of drugs to a third party will receive special attention from drug regulators in pharmacovigilance inspections.
Apr 21, 2022
REGULATION
Law & Regulation Pharmacopoeia MAH Pharmacovigilance Marketing Approval Priority Review Volume-based Procurement
Top 10 BaiPharm Stories of China's Pharmaceutical Regulations | 2021 Recep ChemLinked BaiPharm Portal has been delivering and decoding China's pharmaceutical regulations to help international drug makers access the Chinese market. Here are the 10 regulatory topics that our readers are most concerned about in 2021.
Jan 07, 2022
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