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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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 and Approval Medical 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 CDE 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
China NMPA Announces Key Points for 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 and Approval 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
INDUSTRY
Law & Regulation Pharmacopoeia MAH Pharmacovigilance Marketing Approval Innovative Drug Drug Registration New Drug
CRAC-HCF 2021 | Embracing China's Pharma Market With Regulatory Compliance and Industry Insights Five experts from drug regulation authorities, pharmaceutical companies, and consulting firms decoded drug regulations and analyzed industry dynamics for international pharma companies to develop businesses in the Chinese market.
Nov 17, 2021
INDUSTRY
Law & Regulation Pharmacopoeia MAH Pharmacovigilance Marketing Approval Innovative Drug Drug Registration New Drug
Online Conference | China Drug Regulation and Pharmaceutical Market BaiPharm will hold a virtual conference on Nov. 12, as part of the CRAC-HCF 2021 event. We will have five speeches elaborating on China drug regulations and pharmaceutical market. The specific topics include China market entry strategy, Chinese Pharmacopoeia, GVP, MAH, and innovative drug research.
Oct 21, 2021
REGULATION
Law & Regulation Pharmacovigilance
China to Implement Good Pharmacovigilance Practices 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
Law & Regulation 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.
Mar 08, 2021
REGULATION
MAH Pharmacovigilance Post-market
China Consults on the Draft of Good Pharmacovigilance Practices On Dec. 1, 2020, the National Medical Products Administration (NMPA) issued the draft of Good Pharmacovigilance Practices (GVP) for public comments. Stakeholders could submit feedback to NMPA before Dec. 18, 2020.
Mar 08, 2021
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