EMA

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

2004：VICH GL37： Safety of veterinary drugs in human food repeat-dose (Chronic) toxicity testing - Step 7

2026-06-13

2004：VICH GL31： Safety studies for veterinary drug residues in human food： Repeat-dose (90) toxicity testing - Step 7

2026-06-09

2004：VICH GL23： Safety studies for veterinary drug residues in human food： Genotoxicity studies - Step 7

2026-06-09

2004：Note for guidance on the evaluation of the pharmacokinetics of medical products in patients with impaired renal function

2026-06-09

2004：First cases of bovine spongiform encephalopathy in the United States (USA) and Canada： Risk assessment of ruminant materials originating from the USA and Canada

2026-06-09

2004：Concept paper on the development of a guideline on viral safety evaluation of biotechnological products to be used in clinical trials

2026-06-09

2004：CHMP SWP conclusions and recommendations on the use of genetically modified animal models for carcinogenicity assessment - Revision 1

2026-06-09