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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 | 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
Monthly Recap: China Pharmaceutical Regulatory Updates | June 2022
Check out the pharmaceutical regulatory updates in China: 1.CDE Issues the 2021 China Drug Evaluation Report; 2. CDE Publishes the 2021 Clinical Trial Report; 3. CDE Consults on Communication Procedures for Pediatric Drug Applicants...
Jul 06, 2022
REGULATION
China Implements GMP Appendix for Investigational Products Used in Clinical Trials
On July 1, 2022, the Appendix to GMP for Pharmaceuticals: Investigational Products Used in Clinical Trials comes into effect. The Appendix is a supporting document for China's pharmaceutical GMP, which was revised in 2010 and has been effective since 2011.
Jul 01, 2022
REGULATION
European Commission Publishes Draft on Labeling Requirements for IMPs
With the application of the EU Clinical Trials Regulation some labelling requirements for IMPs have changed, in particular regarding the expiry date. Now an initiative eliminates the obligation to include an expiry date on the immediate packaging of IMPs in specific circumstances.
Jun 22, 2022
REGULATION
EMA Issues New Guidance Documents for GCP Inspections
Following the previously published list of documents needed during GCP inspections, the EMA issued a set of updated documents on planning and conducting GCP inspections on its website. The annexes compile specific items that may be verified at the sponsor / CRO / investigator site and clinical laboratories.
Jun 22, 2022