Drug Regulatory Affairs

Directorate General of Health Services,Ministry of Health & Family Welfare,Government of India is the National Regulatory Authority (NRA) of India.

Drug Regulatory Affairs establish common principles and responsibilities that provide a strong scientific database, efficient organizational arrangements, and procedures to underpin decision making for nutraceutical preparations.

The drug regulatory affairs 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 Drug Regulatory Affairs 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 Drug Regulatory Affairs 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 Drug Regulatory Affairs 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 Drug Regulatory Affairs also contributes to designing of the development programme. The Drug Regulatory Affairs 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 Drug Regulatory Affairs department.

An important proactive task of the Drug Regulatory Affairs is to provide input when legislative changes are being discussed and proposed. In the ICH environment there is a greater possibility to exert influence at an early stage. As a discipline, Drug Regulatory Affairs covers 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 Drug 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 postmarketing 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 Drug 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 Drug 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.
On the consumer side, people in drug regulatory affairs help keep the other two groups honest, and they provide the stimulus for Congress to enact the laws that regulate how government and industry treat products.

Drug Regulatory Affairs liaisons manage the process of working with project teams and interacting with the regulatory health agencies, such as the Food and Drug Administration (FDA) or the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).