SRINIVASA INSTITUTE OF PHARMACEUTICAL SCIENCES
(Recoginsed by A.I.C.T.E and P.C.I. New Delhi, Affiliated to J.N.T.U.A- Anantapur)
AN ISO 9001 - 2008 Ceritified Institution
Department of Pharmaceutics - Drug Regulatory Affairs
The pharmaceutical research and development process of bringing a new drug to the market takes many years; it is therefore essential that the process be managed effectively from beginning to end in order to meet the Canadian regulatory requirements and permit a favorable evaluation of efficacy and safety in the shortest possible time. The drug regulatory affairs (DRA) professional plays an important role in every phase of this process, from developing regulatory strategies following the discovery of a new chemical entity to planning post-marketing activities.
The main responsibility of the DRA professional within a pharmaceutical company is to secure approval of drug submissions from Health Canada's Therapeutic Products Programme (TPP) and to ensure regulatory compliance of marketed and investigational drugs with the Food and Drug Act and Regulations and TPP Guidelines/Policies. In this position, the DRA professional must possess a proficient scientific background (B.Sc, M.Sc., Ph.D., M.D. or Pharm.D.) and have acquired a thorough knowledge of Canadian regulations as well as international regulations. Because the regulatory environment is evolving rapidly toward global harmonization (several ICH guidelines have now been adopted by TPP) and mutual recognition between different health authorities across the world, it is a major challenge for the DRA professional to keep abreast of policy changes and determine how these changes affect the approval process. Consequently, the importance of DRA in the development and approval of new drugs has increased significantly over the last decade.
Whether a submission is filed to the TPP for the conduct of a clinical trial (Investigational New Drug Submission, or IND), for the approval to market a new drug (New Drug Submission, or NDS), for a new indication or dosage form for a marketed drug (Supplemental NDS, or S/NDS), or for the maintenance of a marketed drug's regulatory status, the submission's preparation entails the close collaboration of a multidisciplinary team. The DRA professional must actively participate in discussions and coordinate team activities to obtain all the necessary documentation as per the current TPP policies and then assess it for completeness and accuracy. Therefore, the effective DRA professional must exhibit the organizational and interpersonal skills of a "team player" and also be thorough and detail-oriented.
The scope of responsibilities is wide and may vary significantly according to the organizational structure of the pharmaceutical company. The responsibilities of some DRA professionals may focus exclusively on pharmacovigilance activities or on the electronic representation of information (electronic submissions).
Other responsibilities may include provincial formulary submissions, review of advertising materials, product launch activities, and quality assurance, to name a few. The common point, however, is that the DRA professional is the primary liaison between the sponsor and the TPP. In this capacity, the individual must possess excellent writing and communication skills and be an effective negotiator. This is to ensure that the requests or comments generated during the submissions review process are promptly and satisfactorily answered and to negotiate the most favorable labeling (Product Monograph) consistent with the sponsor's business objectives.
In line with today's growing technological developments, knowledge of several computer applications is essential to effectively fulfill the job requirements.
DRA is a dynamic, rewarding field that embraces both scientific and legal aspects of drug development. DRA professionals are dedicated individuals who take pride in their contribution to improving the health and quality of life of Canadians. Unfortunately, until recently, few university programs included formal training in the field of drug regulatory affairs.