News
Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
Hot topic
REGULATION
Understanding China's Good Laboratory Practice (GLP) Certification Regulation Draft
On Oct. 21, 2022, China NMPA issued the draft of Administrative Measures for Good Laboratory Practice (GLP) Certification for public comments. GLP certification means NMPA inspects and evaluates if research institutes comply with GLP during non-clinical safety evaluation for pharmaceuticals.
Oct 25, 2022
REGULATION
China Provisionally Extends Deadlines for Submitting Drug Registration Applications' Supplemental Documents
On Oct. 14, 2022, China National Medical Products Administration (NMPA) announced it would temporarily extend the deadlines for drug registration applicants to submit supplemental documents. If finding applications deficient, NMPA will issue deficiency letters that require relevant applicants to submit supplemental documents.
Oct 19, 2022
REGULATION
Law & Regulation
Guideline
Pharmacopoeia
Reference Listed Drug (RLD)
GMP
Clinical Trial
NRDL
Health Insurance
Generic Drug
OTC Drug
Cancer
Monthly Recap: China Pharmaceutical Regulatory Updates | September 2022
Find out the latest pharmaceutical regulatory updates in China: 1. China SAMR to Permit Online Sales of Prescription Drugs Nationwide; 2. China NMPA Grants One Rx-to-OTC Switch; 3. China NMPA Releases 183 RLDs; 4. China CFDI Consults on Inspection Guidance for Blood Products; 5. China NHSA Announces 343 Drugs Passing the Format Review for NRDL; 6. China CDE Releases Pharmaceutical Guidelines; 7. Chinese Pharmacopoeia Commission Consults on Drafts of Drug Standards and Guideline
Oct 03, 2022
REGULATION
Law & Regulation
Guideline
Pharmacopoeia
Reference Listed Drug (RLD)
Clinical Trial
Bioequivalence (BE)
Generic Drug
New Drug
COVID-19
Monthly Recap: China Pharmaceutical Regulatory Updates | August 2022
Check out China's pharmaceutical regulatory updates in August: NMPA granted OTC status to Omeprazole Enteric-coated Tablets; NMPA released the 57th List of Reference Listed Drugs (RLDs); NHC Adds Azvudine to COVID-19 Diagnosis and Treatment Protocol; NMPA to Adopt ICH E8 (R1) and E14 Guidelines...
Sep 09, 2022
REGULATION
CMC: FDA Publishes Guideline With Questions on Post-approval Modification of Single-use Materials
With the publication of a question and answer guideline, the FDA is responding to the challenges of the shortage of disposable materials in manufacturing and the requirements for the use of alternative materials in the area of chemistry, manufacturing and controls (CMC).
Aug 19, 2022
REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | July 2022
Check out the pharma regulatory updates in China: The 7th National Volume-based Procurement (VBP) Includes 327 Drug Products; China CDE Consults on Procedures for Starting For-cause Inspections; China CDE Releases Q&A on Immediate Report of Adverse Drug Reactions in Clinical Trials...
Aug 05, 2022
REGULATION