Current regulatory framework for drug approval Sample Clauses

Current regulatory framework for drug approval. ‌ Regulation of the development and dissemination of medical drugs involves competing interests: ensuring that agents are both safe and effective, while facilitating the movement of innovative therapies as rapidly as possible through the investigative process to public use. Balancing these goals is globally in large measure a task of the Federal Food and Drug Administration (FDA) in the United States, and of regional and centralized regulatory bodies in the European Union (EU)(Xxx Xxxxxx 2016). In the drug development process, safety and efficacy testing is an important phase before the drug is tested in human subjects (clinical phase). The guidelines for safety testing of new drugs are harmonised between Europe, Japan and the USA by the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The safety guidelines include guidelines for carcinogenicity studies (S1A-S1C), genotoxicity studies (S2), toxicokinetics and pharmacokinetics (S3A-S3B), toxicity testing (S4), reproductive toxicology (S5), biotechnological products (S6), pharmacology studies (S7A-S7B), immunotoxicology studies (S8), nonclinical evaluation for anticancer pharmaceuticals (S9), photosafety evaluation (S10) and nonclinical paediatric safety (S11)1. Both the FDA and the European Medicines Agency (EMA) are implementing efforts to execute the so- called 3R’s principle in regulatory research, product review practices and policy. The principles of the 3R’s were first defined by Xxxxxxx and Xxxxx (1959). Meanwhile, these principles have been further expanded and now encompass(Xxxxxxx 1995): • Replacement: testing approaches that avoid or replace the use of live animals in an experiment where they would have otherwise been used. Replacement could include the use of established animal and human cell lines, or primary cells and tissues or mathematical and computer models or physicochemical methods. • Reduction: approaches that minimise the number of animals used per experiment or study, either by enabling researchers to obtain comparable levels of information from fewer animals, or to obtain more information from the same number of animals, thereby avoiding further animal use. Examples include improved experimental design and statistical analysis, combination of studies, international harmonisation of testing requirements (e.g. (V)ICH) to avoid duplicate testing and the use of technologies, such as imaging, to enable longitudinal s...