The importance of regulatory affairs
Developing a new drug, from laboratory to clinic, is a complex journey that may require many years. Throughout this process, and even after a new drug reaches the market, a large volume of legislation is in place to ensure safety and efficacy of the new treatment.
In the 90s, as a consequence of incidents caused by inadequately assessed pharmaceutical products, new laws and guidelines were introduced to improve quality, safety and efficacy of the products. This has also resulted in stricter norms for Marketing Authorization (MA) and Good Manufacturing Practices (GMPs).
In Italy, in order to put a new drug on the market, the manufacturer must have obtained the release of the “Marketing Authorization”(Autorizzazione all’ Immissione in Commercio – AIC), issued by AIFA or by the European Commission. The AIC is released only after a careful scientific evaluation, to check the new drug satisfies quality, safety and efficacy requirements. The person requesting the AIC must submit an application, which contains the characteristics regarding the chemical-pharmaceutical, together with preclinical and clinical aspects.
Regulatory affairs encompass the bulk of all regulatory protocols surrounding the development of a new drug and ensure adherence to them at each stage of development. Regulatory affairs play an important role throughout a product’s life cycle, to lead pre-market strategy, to draft regulatory submissions and to ensure post-market compliance. Regulatory Affairs also ensure the maintenance of the marketing license and guide life-cycle extension activities, including broadening the indication of the drug or changes in formulation or dosage.
Regulatory Affairs have therefore a fundamental role for healthcare industries (pharmaceuticals, medical devices, biologics and functional foods), participating during drug development, manufacturing, marketing and clinical research, with a final goal of protecting human health. Most companies, whether they are major multinational pharmaceutical corporations or small and innovative biotechnology enterprises, have a department of Regulatory Affairs composed by specialists. These professionals act as the interface between pharmaceutical industries and government authorities, ensuring safety, efficacy, and quality of drugs, as well as appropriateness and accuracy of product information. Due to the changing resources necessary to fulfill the regulatory requirements, some companies also choose to outsource or out task regulatory affairs to external service providers.
In today’s competitive environment, the reduction of the time taken to reach the market is critical to a product and hence to the company’s success. The proper implementation of regulatory guidelines and laws will safeguard both the company growth and people safety.
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