Role of Regulatory Affairs in Pharmaceuticals
Regulatory
affairs in pharmaceuticals are like vehicle inspectors in the automotive
industry. They assess and perform quality checks to ensure that the medicinal
drugs, veterinary drugs, and nutritional supplements rolled out by the
pharmaceutical industry are safe and effective for the consumers to use. In
other words, regulatory affairs are in place to protect public health by
evaluating the processes of drug discovery, production, and promotion of
pharmaceutical products.
Regulatory
affairs in the pharmaceutical industry comprise of a variety of functions. One
of these functions includes staying abreast of 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 the manufacturing and marketing practices of the
pharmaceutical companies.
In addition,
regulatory affairs are deeply involved in the collecting, collating, 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 it 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, or the Food and Drug
Administration 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 the compilation of the substantive
scientific data and medical issues obtained from the clinical research and
experimental trials conducted on the pharmaceutical drug takes 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 at 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 paramount in protecting the pharmaceutical company from any
liabilities of negligence or oversight, by ensuring the companies keep
thoroughly meticulous 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, so as 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.