Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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
China Rejects Medical Device Registration Applications with Data Authenticity Issues On Jan. 15, 2021, China National Medical Products Administration rejected a company’s medical device registration application because of the data authenticity issue in the clinical trial.
Mar 24, 2021
- China Releases MedDRA Coding Guidance for Adverse Drug Reaction (ADR) Reports
- Generic Drug Application (ANDA) in China
- Monthly Report: New Drug Approvals in China | April 2022
- China Encourages Innovative Drug R&D in Revised Draft of Regulations for Implementing the Drug Administration Law
- Monthly Recap: China Pharmaceutical Regulatory Updates | May 2022