Across the globe every country has their own regulatory authority which is responsible for making guidelines to regulate drug development process, manufacturing, packaging, labeling and licensing. Therefore, it is challenging for the companies to develop a single drug which can be simultaneously submitted in all the countries for approval. Regulatory affairs play vital role in outlining the process of getting a drug approved, and emphasizing the importance of interactions with other functions within the company and with the external regulatory authorities. It serves as the interface between the regulatory authorities and the drug discovery team and aiming to ensure that the drug development plan correctly anticipates what the regulatory authority will require before approving the product.
It is the responsibility of regulatory affairs personnel to keep abreast of current legislation, guidelines and other regulatory intelligence. It plays an important role in giving advice to the project team on how best to interpret the rules.e.g. To discuss such issues as divergence from guidelines, the clinical study progmme, and formulation development.
The regulatory affairs department of pharm industry reviews all documentation from a regulatory perspective, ensuring that it is clear, consistent and complete, and that its conclusions are explicit. The department also drafts the core prescribing information that is the basis for global approval, and will later provide the platform for marketing. The documentation includes clinical trials applications, as well as regulatory submissions for new products and for changes to approved products.
In this highly regulated environment, regulatory affairs plays a critical role not only as the interface with health agencies and as a link between different departments in the company but also as the leading department to provide strategic advice on extremely difficult decisions through the life of a drug. I Anushree Raval, faculty member of Nirma University advise that to stay competitive in pharm regulatory areaAuthor Ms. Anushree H. Raval