News
Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
Hot topic
INDUSTRY
Law & Regulation
Reference Listed Drug (RLD)
Marketing Approval
Bioequivalence (BE)
Drug Registration
CPhI & BaiPharm Event: Generic Drug Application Procedures in China
On June 22, BaiPharm is going to co-organize a webinar with CPhI China on the topic of Generic Drug Application Procedures in China.
Jun 21, 2022
REGULATION
Law & Regulation
Guideline
Pharmacopoeia
Reference Listed Drug (RLD)
MAH
Marketing Approval
CMC
Clinical Trial
Generic Drug
Cell Therapy
Gene Therapy
Drug Registration
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
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
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
INDUSTRY
Marketing Approval
Priority Review
Innovative Drug
Generic Drug
Biological Product
Cancer
Cardiovascular Disease
Rare Disease
Drug Registration
New Drug
Monthly Report: New Drug Approvals in China | March 2022
In March 2022, China NMPA approved 23 new drugs, including 15 chemical drugs and 8 biological products.
Apr 07, 2022
Most Popular
- Monthly Report: New Drug Approvals in China | February 2024
- Monthly Recap: China Pharmaceutical Regulatory Updates | February 2024
- Monthly Report: New Drug Approvals in China | March 2024
- Monthly Recap: China Pharmaceutical Regulatory Updates | March 2024
- China Consults on Self-Evaluation Report Guidance for Generic Drug Registration