Regulatory affairs is the function within our industry that ensures companies comply with the regulations and laws that apply to the pharmaceutical industry.
Regulatory affairs is a broad speciality that often starts early in drug development. It is involved in manufacturing and clinical trials; is key to obtaining a marketing authorisation (MA) and continues throughout the lifetime of a medicine, with involvement in advertising, labelling and the monitoring of safety.
There is a large amount of legislation in place in the UK and Europe to ensure that a new medicine is as effective and safe to use as possible. Regulatory affairs professionals keep track of changes in legislation and ensure that the appropriate clinical trials have been performed prior to the submission of a MA application.
Once a medicine has completed the clinical trials necessary to prove safety, efficacy and quality; a submission is made to the UK or European regulatory authority to gain a marketing authorisation or licence for the product to be launched. For a prescription medicine, this means the medicine will be available for a doctor to write a prescription in normal clinical practice.
Once on the market, there is a large amount of UK and EU legislation also in place to ensure that the risk benefit balance of a medicine is continuously monitored, that labelling and packaging is kept up to date and that manufacturing quality standards are maintained. Regulatory affairs professionals are involved in all these activities as well.
Working with our member companies
We work with our member companies to represent the pharmaceutical industry in the UK on regulatory matters by instilling good practice and innovative approaches to this discipline. We also keep ABPI members informed of regulatory, policy and legislative developments.
UK and European organisations regularly publish consultation documents which include questions or policy statements which affect the regulatory affairs function of the pharmaceutical industry. Here at the ABPI, we work with our members, including our network of regulatory affairs experts (the ABPI Regulatory Expert Network) to share best practice, drive innovation and contribute their specialist knowledge to respond to these consultations.