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Consulting of current regulation and policy
NMPA related application for clinical trial and marketing approval
Compliance support from product development to commercialization
Post-market drug safety and risk management
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
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
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
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
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
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