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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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Monthly Recap: China Pharmaceutical Regulatory Updates | May 2022
Check out the May updates on pharma regulations in China: NMPA publishes MedDRA Coding Guidance for ADR Reports...
Jun 08, 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
INDUSTRY
MAH
Marketing Approval
Priority Review and Approval
Innovative Drug
Generic Drug
Biological Product
Cancer
Drug Registration
New Drug
Monthly Report: New Drug Approvals in China | April 2022
In April 2022, China NMPA approved 23 new drugs, including 20 chemical drugs and 3 biological products.
May 12, 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
CDE Guideline
Reference Listed Drug (RLD)
MAH
GMP
Marketing Approval
Post-market
Generic Drug
Vaccine
GCP
COVID-19
Monthly Recap: China Pharmaceutical Regulatory Updates | March 2022
Check out the pharmaceutical regulatory updates in China: NMPA releases the 52th list of reference listed drugs; China NMPA consults on drug MAH's inspection regulation...
Apr 08, 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
REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | November 2021
1. China Insulin VBP Tender Result;
2. NMPA Launches Drug Supply Information Submission System;
3. NMPAs Requires Documentation for Import/Export Permit of Analgesics and Antipsychotics;
4. NMPA Announces One Rx-to-OTC Switch;
5. The 48th Batch of Reference Listed Drugs;
6. NMPA Approves 110 Medical Devices;
7. NHC Releases Administrative Measures for National Essential Medicine List (Revised Draft);
8. NMPA Releases Administrative Measures for Quality Supervision in Drug Supply, Distribution and Use (Consultation Draft)...
Dec 16, 2021
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
Most Popular
- China Releases MedDRA Coding Guidance for Adverse Drug Reaction (ADR) Reports
- Generic Drug Application (ANDA) in China
- Monthly Report: New Drug Approvals in China | April 2022
- China Encourages Innovative Drug R&D in Revised Draft of Regulations for Implementing the Drug Administration Law
- Monthly Recap: China Pharmaceutical Regulatory Updates | May 2022
