技术导则

2006：Draft reflection paper on the use of pharmacogenetics in the pharmacokinetic evaluation of medicinal products

2026-06-27

2006：Draft guideline on virus safety evaluation of biotechnological investigational medicinal products

2026-06-27

2006：Draft guideline on the development of new medicinal products for the treatment of ulcerative colitis

2026-06-27

2006：Draft guideline on reporting the results of population pharmacokinetic analyses

2026-06-27

2006：Draft guideline on clinical trials with haemopoietic growth factors for the prophylaxis of infection following myelosuppressive or myeloablative therapy

2026-06-27

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