Importance of Regulatory Affairs in Pharmaceuticals

Regulatory affairs play an important role in pharmaceuticals. It plays an important role from the discovery of new molecules to the commercialization of pharmaceutical products. It has various roles in the manufacturing of pharmaceutical products.

Regulatory affairs evaluate and perform quality checks to ensure that the pharmaceutical products, cosmetics and nutritional supplements rolled out by the pharmaceutical industry are safe and effective for consumer use. In other words, regulatory affairs are in place to protect public health by assessing the processes of drug discovery, manufacturing, and promotion of pharmaceutical products.

Regulatory affairs in the pharmaceutical industry comprise a variety of functions. One of these functions includes staying up-to-date on the changes in the legislation of pharmaceutical drug research, manufacture, and marketing. This is a critical task as keeping updated on the rules and regulations of the pharmaceutical industry will govern manufacturing and marketing practices of pharmaceutical companies.

In addition, regulatory affairs are deeply involved in the collecting, reviewing, and compiling of scientific data for assessment in search of discrepancies or compromises in quality. This is often accomplished by gathering the numerous registration documents, which are organized into sections called Common Technical Documents, and consolidating them to form a dossier for each pharmaceutical product of a specific dosage and strength.

The consolidated dossier by regulatory affairs professionals will be submitted for review by regulatory agencies such as the FDA, EMEA, or any other agencies before authorization can be granted for the manufacture, marketing, and sale of the pharmaceutical product.

This aspect of regulatory affairs is undeniably the most important element of the job, as determines whether the pharmaceutical product will ever be released into the market. The collection, consolidation, and compilation of the substantive scientific data and medical issues obtained from the clinical research and experimental trials conducted on pharmaceutical drugs take up the lion's share of regulatory affairs.

Hence, it is quite evident that regulatory affairs are crucial in navigating the course of product development and product launches in the mammoth industry that is the pharmaceutical sector. Perched in a position where regulatory affairs can deliver vital strategic guidance and technical advisory to pharmaceutical multinational corporations, its work is integral for the scientific and commercial success of a pharmaceutical product, right from the conception of the idea at the stage of research and development, throughout the rigorous process of clinical trials, and finally onto marketing and branding before it sees the light of day.

Regulatory affairs are also essential in protecting the pharmaceutical company from any liabilities of negligence or oversight, by ensuring the companies keep thoroughly accurate documentation of clinical findings, scientific data, and accurate demonstrations of feedback on the efficacy and side effects of the drugs tested.

In addition, regulatory affairs extend its influence onto coordinating with various other regulatory agencies and departments to facilitate the submissions of proper and precise information for evaluation, to secure a swift and successful approval for the pharmaceutical products to penetrate and perform in the market. Hence, regulatory affairs are the language that the international drug regulatory ecosystem speaks and allows the communication between teams of multi-disciplinary individuals to facilitate the life cycle of pharmaceutical products.

Major Regulatory Agencies World Wide