技术导则

2006：Draft appendix 1 to the guideline on the evaluation of anticancer medicinal products in man (CHMP／EWP／205／95 rev. 3), methodological considerations for using Progression-Free Survival (PFS) as primary endpoint in confirm...

2026-06-27

FDA（2026）：Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials Guidance for Industry

2026-06-23

2006：Concept paper on the revision of the guideline for the conduct of bioequivalence studies for veterinary medicinal products (EMEA／CVMP／016／00) - Revision 2

2026-06-13

2006：Concept paper on the preparation of a guideline on the clinical development of products for specific immunotherapy for the treatment of allergic diseases

2026-06-13

2006：Concept paper on the development of a guideline on the assessment of genotoxic constituents in herbal substances／preparations

2026-06-13

2006：Concept paper on the development of a CHMP guideline on the non-clinical requirements to support early phase I clinical trials with pharmaceutical compounds

2026-06-13

2006：Concept paper on the development of a CHMP guideline on the non-clinical requirements to support early phase I clinical trials with pharmaceutical compounds

2026-06-13

2006：Concept paper on guideline on immunogenicity assessment of therapeutic proteins - First version

2026-06-13

2006：Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance： Non-clinical and clinical issues - First version

2026-06-13

2005：VICH GL28： Studies to evaluate the safety of veterinary drugs in human： Carcinogenicity testing - Step 7 (after revision on step 9)

2026-06-13

2005：Recommendations on the need for revision of the guideline on clinical investigation of medicinal products for prophylaxis of intra- and post- operative venous thromboembolic risk (CPMP／EWP／707／98)

2026-06-13

2005：Guideline on the evaluation of control samples in nonclinical safety studies：checking for contamination with the test substance

2026-06-13