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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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REGULATION
China to Tighten Regulation on Drug Marketing Authorization Holders (MAHs) That Outsource Manufacture
On May 24, China NMPA issued the draft Notice of Enhancing the Supervision of Drug Marketing Authorization Holders (MAHs) That Outsource Manufacture. The Notice came with an appendix: Guidance for On-site Inspection of Drug MAHs That Outsource Manufacture. The draft is open to public advice until June 23 this year.
Jun 02, 2023
INDUSTRY
Top 10 CROs Using China's Human Genetic Resources in International Clinical Trials
From Jan. to Oct. 2022, among the 3,632 international clinical trials approved by China to use the its human genetic resources outside China, about 52% are conducted by contract research organizations (CROs) and about 48% by the applicants themselves.
Nov 23, 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
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