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- 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
- Technical Guideline for Preventive Vaccines with Aluminum-containing Adjuvants2024-12-20
- Guideline on the Chemistry, Manufacture and Control (CMC) of Prophylactic COVID-19 mRNA Va...2024-12-20
- Technical Guidelines for the Pharmaceutical Study and Evaluation of in Vivo Gene Therapy P...2024-12-20
- Guideline for Chemistry, Manufacturing, and Control (CMC) Studies and Evaluation of Immune...2024-12-20
- Technical Guideline for the Chemistry, Manufacturing, and Control (CMC) Study and Evaluati...2024-12-20