AGES Experts as Rapporteurs for Revision of ICH Guideline on Reproductive Toxicology
AGES MEA experts are continuously working on the third revision of the international guideline ICH S5(R2) "Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility", which has now been made available for public comment for the first time (CPMP/ICH/386/95).
For a long time, as a result of the bitter experience with thalidomide, the examination of embryofetal developmental toxicity in the context of preclinical studies has usually had to be carried out by studies in rats and rabbits. More than 20 years ago, a harmonized guideline was created for this purpose within the framework of the ICH ("International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use") in the form of ICH S5.
Since then, numerous experiences with established, but also new, "alternative" (e.g. in vitro or ex vivo) test methods have been gained. A significant cornerstone of the draft revision of the ICH S5 guideline is the specification for the first time of a framework for qualifying alternative test methods for regulatory purposes. As finalized ICH guidelines are implemented in the world's largest pharmaceutical markets, this is expected to have a stronger long-term positive impact on animal welfare than regionally restricted measures. The document, which was previously limited to chemically manufactured pharmaceuticals, is now also applicable, for example, to biotechnologically manufactured products and certain vaccines. Furthermore, updates were made to details of the already established test methods.
The ICH working group is currently composed of more than 34 representatives of authorities and industry from 15 different countries (Australia, Brazil, EU, Singapore, USA, Japan, Canada, Switzerland,...).
The main responsibility of the AGES Medical Market Authority for this comprehensive revision of a guideline underlines the confidence in the competence and expertise of the AGES MEA experts, which goes beyond Europe. In addition, this demonstrates the importance of the collaboration of national experts in the further development of guidelines in order to be perceived internationally as an expert organization in an increasingly global drug development.
