The structure and format of applications to be submitted to regulatory authorities in the USA, Europe, and Japan has been defined within the International Conference o
Most health authorities promote the development of orphan drugs, by offering a series of incentives to companies developing treatments or diagnostics for rare diseases.
Regulators’ review of a Clinical Trial Application (CTA) is, for a part, based on information about the investigational medicinal product(s) (IMP) provided by
The conduct of clinical trials is subject to prior authorization from health authorities, to ensure the protection of clinical trial subjects.
Whilst marketing approval is granted for a given product, the company applying for marketing license may also be subject to certification by regulatory authorities.
The marketing of medicinal products is conditioned by regulators’ approval, in order to ensure that therapeutic benefits outweigh risks.