Regulatory Affairs / Marketing Authorization
Once the development of a medicament has been completed, it must be approved to receive market authorization from the international drug regulatory authorities. In Germany, this is a task of the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfarM) in Bonn, formerly these matters were in the hands of the German Health Authority.
BfarM verifies all information on the efficacy and especially the lack of side effects of the respective drug, the production methods, issues on application and applicability and the describing texts (package insert, packaging) as well as other formal data.
Therefore it is necessary to accompany the development of a drug or an agent or combination of agents, if required, to ensure the compliance of the product with regulatory requirements regarding its quality, efficacy and safety and to be able to submit the application at the respective regulatory authority.
Once a drug has been approved, it must be continuously managed to extend its approvals, adapt them to the latest state of scientific knowledge by complementary advices of amendment, expanded indications etc.
During the development of a drug and also after its approval, the multitude of tasks regarding the management of market authorizations can only be handles in close cooperation with other lines of business. Often, positions in drug regulatory affairs serve as interface to lines of business such as production, quality control, quality assurance, toxicology, medicine and drug safety, but also marketing and medical science.
Typical drug regulatory affairs positions include: