The role of regulatory affairs in enabling innovation 26 Jan 2021
The role of regulatory affairs is paramount in enabling the delivery of new medicines to patients. From keeping track of legislation, managing documents and registrations for marketing authorisations with regulatory authorities, and providing strategic and technical advice on development programmes, the function underpins the pharmaceutical industry’s vital work. Unsurprisingly, regulatory affairs teams faced significant disruption in 2020 with the pandemic creating additional volatility and pressure. Yet, with a common goal of tackling COVID-19, the global pharmaceutical industry has responded with unparalleled speed and agility. In turn, regulatory agencies and regulatory affairs groups have been thrust into the limelight, steering a challenging course to swiftly approve therapies and vaccines while ensuring appropriate rigour and robust processes.
So, as we move into 2021, regulatory affairs’ role is likely to be more instrumental than ever- but what are the key trends we can expect to see? At our upcoming virtual breakfast briefing on February 10th, we will welcome Zubair Hussain, Chairman of LE4D Global Regulatory and a PharmaMedic partner to discuss how regulatory affairs is poised to enable innovation in 2021.
The first area he will tackle is the 2019 recommendation paper from Clinical Trials Facilitation Group (CTFG) on complex clinical trial designs. Use of complex and innovative trials is on the rise, especially in oncology and rare diseases where data is scarce, and patient enrolment is challenging. Innovative approaches like platform designs or synthetic controls are fast and efficient but analytically and operationally challenging. The recommendation paper from CTFG reflects a growing regulatory interest and support for methods that can help to overcome innovation barriers and address areas of unmet medical need. Indeed, the FDA recently finalised its Complex and Innovative Trial Design guidance in December 2020.
The second issue that continues to dominate regulatory discussions in the UK and the EU is how the newly inked Brexit deal will translate into regulatory guidance and the extent to which the MHRA will remain aligned with the European agencies or forge a new path. The Brexit preparatory work for regulatory affairs professionals was intensive, and the transitional work will undoubtedly be more so.
Meanwhile, regulatory affairs professionals working in the medical device field will be tackling the implications of regulatory changes that mean an increased expectation for the clinical evidence required to register and approve a medical device.
One thing is certain, we are likely to face another period of rapid change and evolution in the coming months. In the words of Walt Disney “Times and conditions change so rapidly that we must keep our aim constantly focused on the future.”
To learn more on these topics as well as insights on the medical affairs environment in 2021, click here to register for our upcoming webinar.