Drug Approval Process

Most countries have their own regulatory body to control the development and marketing approval of a drug. The largest regulation authorities are the FDA (Food and Drug Administration) in the USA and the EMA (European Medicines Agency) in the EU.

Following the completion of all three phases of clinical trials, the pre-clinical, non-clinical (incl. toxicology), technical/quality (CMC = chemistry, manufacturing and control) and clinical data are compiled and submitted to the regulatory authorities for application of a market authorization. The dossier submitted contains all of the scientific development, efficacy and safety information as well as toxicological, pharmacological and technical/quality that the company has gathered. The regulatory authority assesses the data and information in the document to ensure that the drug has successfully demonstrated no unacceptable toxicological risk, sufficient safety and tolerability, appropriate quality of the medicinal product and efficacy in patients, as well as a positive benefit/risk balance.

Upon approval, a drug may only be marketed for the approved indications in the approved dosage forms and at the approved doses. Following regulatory approval and during the market life of the product, the regulator continues to monitor the marketed drug, its manufacturer and its manufacturing facilities to ensure that it continues to fulfil the applicable standards. Discovery of previously unknown problems with a medicine, device, manufacturer or facility may result in restrictions on the marketing or manufacturing of an approved drug, including costly recalls or withdrawal of the drug from the market.