The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted 2 annexes to the guidelines of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
The regulator’s decision came after 2.5 years of public consultations. Thus, 2 documents are scheduled to come into force in July 2020:
- annex ICH E9 (R1) to the manual on statistical principles for clinical trials on sensitivity assessment and analysis;
- guidelines ICH S5 (R3) on reproductive toxicology: determining the reproductive toxicity of pharmaceuticals for human use (3rd edition).
The updated version of the document describes the principles of studying the reproductive toxicity of vaccines, some biopharmaceuticals, except for drugs of cell and gene therapy, tissue engineering. The guidelines discuss dose selection and risk assessment.
CHMP EMA has also adopted the ICH M9 guidelines for biopharmaceutical classification system based on biowaivers. It will come into force simultaneously with ICH E9 (R1) and ICH S5 (R3).