National drug authorities require registration of any drug before making them available to patients. The drug sponsor files a marketing authorisation application which demonstrates that the drug is of sufficient quality and is safe and effective when used according to product labelling. Review of the marketing authorisation application usually takes at least 1 year and the sponsor may amend the application during this process. 

In Europe, an applicant can choose between different registration procedures that involve just some or all of the EU countries, depending on the type and scope of the product. For new chemical entities, authorisation is granted by the European Commission and it is valid in all EU countries if a positive assessment has been made by the European Medicines Agency (EMEA).

Active interaction with the authorities

During drug development, collaboration with the authorities is usually initiated well before compilation of the marketing authorisation application. National authorities will evaluate all clinical study plans in each participating country. During development there is almost always a need to consult the authorities about developmental challenges in particular, if published regulatory authority guidance is not available.  In Europe this authority consultation discussion is called scientific advice. It might be important to agree with the authorities on the appropriateness of a clinical end point or patient groups studied for an intended indication. Scientific advice makes it easier for a sponsor to maximize the amount of information from clinical studies. Moreover, this helps get medicines more quickly and efficiently into the hands of the physicians and patients that need these products.

All changes reported

Regulatory experts are involved throughout drug development including the post-approval period when the drug is placed on the market. After the registration phase, the marketing authorisation holder is obligated to report any change which could affect the quality, safety or efficacy of the drug. Regulatory affairs also co-ordinates additional changes to a marketing authorization during the maintenance and life cycle management of a product (e.g. new product strengths, formulations or indications).