What is Regulatory Affairs?
Regulatory affairs cover a broad range of specific skills and occupations. Under the best of circumstances, it is composed of a group of people who act as a liaison between the potentially conflicting worlds of government, industry, and consumers to help make sure that marketed products are safe and effective when used as advertised. People who work in regulatory affairs negotiate the interaction between the regulators (the government), the regulated (industry), and the market (consumers) to get good products to the market and to keep them there while preventing bad products from being sold.
The range of products covered is enormous, including foods and agricultural products, veterinary products, surgical equipment and medical devices, in vitro and in vivo diagnostic tools and tests, and drugs (which range from small molecules to proteins). The range of issues addressed is huge, such as manufacturing and analytical testing, preliminary safety and efficacy testing, clinical trials, and post marketing follow-up. Advertising issues, with a healthy dose of data management, document preparation, project management, budgeting, issue negotiation, and conflict resolution, are thrown in the mix.
Over the years, a complicated system of checks and balances has developed to set in place a process to efficiently and effectively regulate the marketing of products. On the industry side, people in regulatory affairs work with research scientists, clinicians, manufacturing groups, and sales and marketing groups to make sure that the government has the information it needs to judge a product. On the government side, people in regulatory affairs work to interpret and implement laws that Congress establishes to help protect the public. To carry out the congressional mandate, the Food and Drug Administration (FDA) requires pharmaceutical companies to generate and provide all the information deemed necessary to evaluate a given drug, biologic, and/or device with respect to safety and efficacy. This information is used by the agency to decide whether the product should be on the market—and if so, how it should be marketed and sold.
The role of the regulatory affairs department
The regulatory affairs (RA) department of a pharmaceutical company is responsible for obtaining approval for new pharmaceutical products and ensuring that approval is maintained for as long as the company wants to keep the product on the market. It serves as the interface between the regulatory authority and the project team, and is the channel of communication with the regulatory authority as the project proceeds, aiming to ensure that the project plan correctly anticipates what the regulatory authority will require before approving the product. It is the responsibility of RA to keep abreast of current legislation, guidelines and other regulatory intelligence. Such rules and guidelines often allow some flexibility, and the regulatory authorities expect companies to take responsibility for deciding how they should be interpreted. The RA department plays an important role in giving advice to the project team on how best to interpret the rules. During the development process sound working relations with authorities are essential, e.g. to discuss such issues as divergence from guidelines, the clinical study programme, and formulation development.
Most companies assess and prioritize new projects based on an intended Target Product Profile (TPP). The RA professional plays a key role in advising on what will be realistic prescribing information (‘label’) for the intended product. As a member of the project team RA also contributes to designing of the development programme. The RA department 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. The latter is a major task and accounts for about half of the work of the RA department.
Regulatory Affairs Profession
The (Healthcare) Regulatory Affairs Profession is still an emergent profession but has two major international professional membership societies: The Regulatory Affairs Professionals Society, RAPS, The Organisation for Professionals in Regulatory Affairs, TOPRA, In Canada, the major professional membership society is: The Canadian Association of Professional Regulatory Affairs, CAPRA,