News
Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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POLICY
China Emphasizes Rare Disease & Pediatric Drugs in Adjusting the 2022 National Reimbursement Drug List (NRDL)
On June 29, 2022, China NHSA issued the Work Plan for Adjusting the 2022 National Reimbursement Drug List (NRDL). NRDL is a list of drugs covered by the basic national insurance for healthcare, employment injury, and maternity.
Jul 04, 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

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
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
CDE 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
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