Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
China Releases Guidance for Declaration of Chemical Drug Changes On Feb. 10, 2021, China Center for Drug Evaluation issued and started implementing the Guidance for Acceptance and Review of Chemical Drug Changes (Trial). The document addresses supplemental applications that entail the reviews of state-level drug regulatory authorities, including those submitted during clinical trials.
Mar 19, 2021
China Requires Drug Market Authorization Holders to Submit Annual Report On Dec. 10, 2020, the National Medical Products Administration (NMPA) published the drafts of Administrative Provisions of Annual Drug Reports and Template for the Annual Drug Report, asking for public consultation before Dec. 22, 2020.
Dec 11, 2020
China Consults on the Draft of Good Pharmacovigilance Practices On Dec. 1, 2020, the National Medical Products Administration (NMPA) issued the draft of Good Pharmacovigilance Practices (GVP) for public comments. Stakeholders could submit feedback to NMPA before Dec. 18, 2020.
Dec 02, 2020
- Monthly Recap: China Pharmaceutical Regulatory Updates | July 2021
- China Drug Evaluation Report 2020-Reform of Drug Review & Approval System
- Monthly Report: New Drug Approvals in China | Aug. 2021
- Monthly Recap: China Pharmaceutical Regulatory Updates | Aug. 2021
- China to Exempt Eligible Medical Devices and IVD Reagents from Clinical Evaluation or Trials