Given the rapidly changing environments, roles and responsibilities recently, we take a minute to just remind ourselves and reset the definition of the role of regulatory affairs.
Professionals in this space are the bridge between the conflicting spheres of industry, government agencies, and patients — helping to ensure that marketed products are of a defined quality, safe and effective when used correctly.
In fact, regulatory affairs does not just apply in a healthcare setting, but across a range of industries including food, agriculture, banking, and energy, among others. It is the responsibility of regulatory affairs specialists to protect the rights, health, and safety of consumers and is therefore essential to the functioning of societies and economies.
What is a regulatory body?
To understand regulatory affairs, one must understand what a regulatory body is; a public or government agency that is created to oversee specific industry practices, providing and enforcing health and safety standards based on legal mandates or legislation.
Examples of regulatory bodies in relation to drugs and medical devices include:
- United States Food and Drug Administration (FDA)
- European Medicines Agency (EMA)
- Medicines and Health products Regulatory Agency (MHRA — UK)
- Pharmaceutical and Medical Devices Agency (PMDA – Japan)
- National Medical Products Administration (NMPA — China)
What does a regulatory affairs (RA) professional do?
A regulatory affairs professional may work either in-house where the product being developed is manufactured, within a government agency, or within a third-party consultancy.
One of the responsibilities of RA departments is to assist in obtaining and monitoring government approval of products from regulated industries — helping companies in these sectors to adhere to the appropriate licensing, marketing, and legal compliance standards.
A person working in this role will be involved in all stages of the project, including manufacturing, analytical testing, preliminary safety and efficacy testing, clinical trials, and post-marketing follow up. A lot of the process includes project management, negotiating issues and conflict resolution.
Typically, their responsibilities include:
- Keeping abreast of ever-changing and ever-evolving legislation, and feeding back to the product development team
- Collect, collate, understand and analyse data from a range of sources
- Ensure all documents are clear, concise, and explicit — and review all from a regulatory standpoint
- Advise on the legal and scientific requirements related to products and projects
- Create and present registration documentation to the relevant regulatory bodies, including carrying out negotiations to obtain Marketing Authorisations (MA) for the product in question
- Submit applications (including for clinical trials and marketing authorisations)
- Submit applications for changes to existing products
- Maintain records to the highest degree of accuracy
- Give input on the development of products and their marketing concepts, including the design of the development programme
Why are they necessary?
The regulatory affairs person or team is the conduit between the regulatory agency and the company. They will negotiate with the agency on behalf of the company, and provide strategic advice and recommendations at the highest level within the business.
Without this bridge, the process would be unmanageable and extremely difficult to navigate.
At Woodley BioReg, we have a team of regulatory affairs consultants on hand to assist at any stage of product development or maintenance.
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