Regulatory News
Position ：
- China deepens comprehensive reform to strengthen drug, medical device regulation
2025-01-09 - 14th China International Medical Device Regulatory Forum Held in Wuhan2024-12-23
- Technical Requirements for Registration Application at Pilots of Segmented Manufacturing o...2024-12-20
- Common problems and technical requirements of replication competent lentivirus detection2024-12-20
- Technical Guideline for Quality Control of Polysaccharide Conjugate Vaccines (Draft for C...2024-12-20
- Technical Guideline on CMC Studies and Changes of Biological Products during Clinical Tria...2024-12-20
- Dossier Requirements for Drug Marketing Authorization Application for The Transfer of Drug...2024-12-20
- Technical Guidelines for Studies on Pharmaceutical Changes of Marketed Vaccines (Interim)2024-12-20
- Technical Guideline for Antibody-Drug Conjugate Pharmaceutical Study and Evaluation2024-12-20
- Questions and Answers on the Manufacturing Changes of Autologous CAR-T Cell Therapy Produc...2024-12-20