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.
European Medicines Agency (EMA) illustrated brochure explaining how the European regulatory system for medicines operatesThis EMA brochure describes how medicines are authorised and monitored in the European Union (EU) and how the European medicines regulatory network – a partnership between the European Commission, the 50 medicines regulatory authorities in the EU and the European Economic Area (EEA), and the EMA – works to ensure that patients in the EU have access to safe and effective medicines.
There is a need to develop and license medicines more efficiently, to respond to both patient demand and the rapid pace of scientific change. These are the drivers for regulatory innovation.
Adaptive licensing is a promising new approach to gaining a marketing authorisation (or license), compared to conventional single approval after a clinical development programme. In this, a medicine is first licensed in a targeted group of patients, then, via flexible evidence gathering, the license is expanded or restricted as data is generated. This is balanced with more controlled access and closer safety monitoring while the benefit: risk balance of the medicine is further characterised (see drug safety section).
Adaptive licensing has the potential to make medicine development more efficient, and speed patients' access to medicines where there is high medical need. The key to success is involving all stakeholders: industry, academia, regulators, payers/providers and the healthcare system. ABPI is engaging nationally and internationally on this topic. Based on the initial experience gained from EMA’s adaptive licensing pilot project, frequently asked questions from companies have been produced to clarify the terms of engagement and expected outputs for prospective applicants. The FAQ document clarifies the criteria used by the EMA to select suitable candidates for the pilot project; the concrete steps involved in the process and expected outcomes; and the context and aim of the exploratory discussions between the EMA and selected candidates.
The Early Access scheme is a UK scheme where MHRA will provide a scientific opinion on the benefits and risks for selected medicines prior to formal marketing authorisation, where there is high unmet medical need and where appropriate data has been generated. As a result, it is anticipated that these medicines could be made available to the NHS up to 6 to 12 months earlier. The scheme launched in April 2014.
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.