Understanding the Role of Regulatory Affairs in Product Development

Every stage of pharmaceutical product development- all the way to commercialization- relies heavily on regulatory affairs to help ensure that all processes involved during development are compliant with the regulations of the relevant authority, internal policies, and guidelines associated with safety, labeling, etc. The profession was developed to address the government’s requirements in protecting human health by controlling and monitoring the safety and efficacy of pharmaceutical and allied products. Furthermore, the need to oversee the activities and processes of pharmaceutical companies in terms of drug discovery, drug/substance testing, manufacturing, and marketing was priority in order to make sure that the products were safe to use and of high quality.

What are the roles and responsibilities of a regulatory affairs professional?

Regulatory affairs professionals help facilitate the necessary processes by staying updated with the latest version and updates of legislations and requirements for all countries in which the pharmaceutical organization aims to market and/or distribute its products. They are expected to provide guidance and advice on the legal and scientific requirements while also collecting and collating relevant scientific data. Regulatory affairs professionals must also present product registration documents to the relevant agencies and act as the communication point between the pharmaceutical company and the agency. Finally, regulatory affairs professionals must also take part in developing the regulatory strategies required for obtaining product market approval while maintaining regulatory compliance. This is crucial as robust regulatory strategy determines the product’s lifecycle.

Regulatory affairs in the USA

Indeed, regulatory affairs professionals work in accordance with regulatory agencies and their requirements for a particular market that the pharmaceutical company wishes to obtain product approval in. For example, in the USA, the Food and Drug Administration (FDA) is the regulatory body that governs all regulatory activities and operations related to pharmaceutical, food, and allied products. Hence, regulatory affairs professionals must ensure that they are aware of the changes in regulations and recent updates, and provide regulatory services in USA accordingly.

The US FDA is responsible for safeguarding public health by controlling and monitoring food, tobacco, caffeine, dietary, prescription, OTC, vaccines, biopharmaceuticals, blood transfusions, medical devices, vet products, and so on. It is considered to be a stringent regulatory authority (SRA) which means that the regulations and standards are stringent for safety, efficacy, and quality processes. Many agencies around the world refer to US FDA guidelines for their product development.

Outsourcing regulatory affairs

Companies are gradually making the shift from conducting in-house regulatory affairs operations to outsourcing them for reasons pertaining to cost-savings, optimization of resources, among others. Therefore, regulatory consulting organizations that specialize in these functions are desired by pharmaceutical organizations so that they can alleviate the burden of their in house departments and focus on other business adding processes.

Conclusion

Regulatory affairs is crucial for product development. While in-house teams have the knowledge and capability to do so, outsourcing such functions is the new normal from a perspective of cost and resource-saving point of view.