Therapeutic biopharmaceuticals such as therapeutic monoclonal antibodies are subject to strict regulations, which must be complied with by the producers in order to obtain approval. In Europe, the European Medicines Agency (EMA) is responsible for the evaluation of medicinal products. Their US-American counterpart is the Food and Drug Administration (FDA), a federal agency of the United States Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of, vaccines, allergenics, cell and tissue-based products, and gene therapy products. In both cases an extensive premarket approval process for new biologics is required.
The approval process
Although authorities try to strip down and simplify the approval for biopharmaceuticals, it remains a long and costly process. Even if the drug is already on the market, post-market safefty monitoring is required and may not only differ between currency unions but the countries itself. Further information to their respective guidelines required for approval down below.
Additional Guidelines
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) supports discourse between the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration.
Good Clinical Practice (GCP) is an international ethical and scientific standard, by ICH for the planning, conduct, documentation and reporting of clinical trials in humans. Compliance with this standard creates public confidence that the rights, safety and welfare of trial subjects are protected in accordance with the Helsinki Declaration and that the data collected in clinical trials are credible.
The World Health Organization’s (WHO) operational role includes leading and coordinating the health response in support of countries, undertaking risk assessments, identifying priorities and setting strategies, providing critical technical guidance, supplies and financial resources as well as monitoring the health situation. The WHO put together some general guidelines in the evaluation of similar Biotherapeutic Products.