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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
REGULATION
Law & Regulation Pharmacopoeia Excipient
Chinese Pharmacopoeia Commission Seeks Public Advice on Colorant Standards The Chinese Pharmacopoeia Commission is currently asking for public advice on colorant standards. The target colorants include but are not limited to colorants used in pediatric drugs, or widely used in pharmaceuticals, or whose current quality control standards are incomplete, especially for operation, and whose current standards cannot meet the need for medical use.
Jul 18, 2022
REGULATION
Law & Regulation Vaccine
China Publishes Vaccine Manufacture & Distribution Rules with Immediate Effect On July 8, China NMPA released the Administrative Rules on Vaccine Manufacture and Distribution with immediate effect.
Jul 14, 2022
REGULATION
Law & Regulation Guideline Pharmacopoeia MAH Clinical Trial NRDL Drug Registration
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
Law & Regulation GMP Clinical Trial GCP
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
Law & Regulation Clinical Trial EU
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
Law & Regulation Clinical Trial CRO GCP EU
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
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 GMP Packaging
China Consults on GMP for Pharmaceutical Packaging Materials On June 2, China NMPA released the draft of Good Manufacturing Practice (GMP) of Pharmaceutical Packaging Materials for public comments. The Packaging GMP specifies basic requirements for the manufacture management and quality control of pharmaceutical packaging materials.
Jun 09, 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 GMP CMC Clinical Trial
China Specifies GMP Regulations on Investigational Products Used in Clinical Trials On May 27, China NMPA released the Appendix to Good Manufacturing Practice (GMP) for Pharmaceuticals: Investigational Drugs Used in Clinical Trials, which will take effect on July 1, 2022.
Jun 06, 2022
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