技术导则

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

2005：Guideline on the clinical investigation of medicinal products indicated for generalised anxiety disorder

2026-06-13

2005：Guideline on procedural aspects regarding a CHMP scientific opinion in the context of cooperation with the World Health Organization for the evaluation of medicinal products intended exclusively for markets outside the C...

2026-06-13

2005：Environmental risk assessments for medicinal products containing, or consisting of, genetically modified organisms (GMOS) (module 1.6.2)

2026-06-13

2005：Draft guideline on the clinical investigation of the pharmacokinetics of therapeutic proteins

2026-06-13

2005：Draft concept paper on the development of a guideline on the non-clinical__Studies prior to clinical use of gene therapy medicinal products

2026-06-13

2005：Concept paper on guidance on the approach on how to demonstrate whether a substance is capable of pharmacological action or not

2026-06-13

2005：CHMP SWP reflection paper on the assessment of the genotoxic potential of antisense oligodeoxynucleotides

2026-06-13