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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
POLICY
NRDL Cancer Rare Disease
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
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
GMP Marketing Approval CMC Clinical Trial Post-market Generic Drug GCP Drug Registration
China CFDI 2021 Drug Inspection Overview In 2021, China CFDI completed 1,368 drug inspections, including 1,214 drug registration inspections, 101 drug supervision inspections, 6 overseas inspections, and 47 license inspections.
Jun 30, 2022
POLICY
Volume-Based Procurement
China Kicks off the 7th Round of Volume-based Procurement (VBP) of Drugs On June 20, China National Joint Drug Procurement Office announced the start of the 7th round of volume-based procurement (VBP), covering 59 drugs with different active pharmaceutical ingredients.
Jun 24, 2022
REGULATION
Law & Regulation Clinical Trial
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
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
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
INDUSTRY
MAH Marketing Approval Innovative Drug Drug Registration New Drug
Monthly Report: New Drug Approvals in China | May 2022 In May 2022, China NMPA approved 12 new drugs, including 10 chemical drugs and 2 biological products.
Jun 07, 2022
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