Regulatory Guidelines

Listed below are some regulatory landmarks for safety pharmacologists, introducing a uniform strategy for safety assessment in core battery systems.

ICH Guidelines: The International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use is a unique project that brings together the regulatory authorities of Europe, Japan, and the United States and experts from the pharmaceutical industry to discuss scientific and technical aspects of product registration. S7A & S7B Guidelines.

FDA/EMEA: The Food & Drug Administration (FDA), Health Canada, the Japanese Ministry of Health and Welfare (MoHW) and the European Medicines Agency (EMEA) subscribe fully to the ICH gudielines as pertains to safety pharmacology studies.

Good Laboratory Practices (GLP): ICH guidelines S7A & S7B require that safety pharmacology studies be conducted in compliance with current Good Labratory Practices (GLP) whenever possible. The S7 guidelines include a provision which recognizes the “unique design and practical considerations” associated with some pahracology studies, and underline the importance of assuring data quality and intergrity, even in the absence of strict adherence to the GLPs.

Electronic Data Management: FDA documents 21 CFR Part 11, entitled “Electronic records; electronic signatures; final rule” is an American FDA guideline intended to permit the widest possible use of electronic technology in drug development, compatible with the FDA’s responsibility to promote and protect human health.