The Regulatory Affairs department is charged with upholding a medicine’s compliance – throughout its life cycle – with regulatory standards laid down by national and supranational health authorities.
For a medicinal product to be placed on the market, it must first be granted a Marketing Authorization (MA) issued by national or supranational competent authorities. The product is then subject to regulatory monitoring throughout its life cycle.
Regulatory Affairs are therefore vital to the development of a new medicine. They work closely with R&D and Industry teams to provide support with dossier registration procedures. They are the preferred go-to contacts of the health authorities, especially when it comes to arranging scientific advisory services with local agencies.
Once on the market, a medicinal product remains under strict surveillance. Consequently, its benefit-risk ratio is continually assessed to take account of any known or newly identified adverse reactions and to update information provided to healthcare professionals and patients.
Regulatory Affairs also play an important role in the validation of promotional items, ensuring that marketing promotions and campaigns comply with the regulations in force in different countries. Additionally, they must ensure proper compliance with regulations and procedures relating to pharmaceutical responsibility as defined by the Chief Pharmacist.