Working in regulatory affairs means supporting medicines developers in various ways, but the common theme is to ensure that medicinal products can be approved for human use either in a clinical trial or under a commercial licence. This approval is given by regulatory agencies based on medicinal products meeting the legislative requirements of quality, safety and efficacy.
Although medicinal product legislation does not change frequently, the guidelines that are used to implement it are continually evolving, and regulatory agencies (e.g. EMA in Europe, FDA in the US) also continue to develop new and improved procedures for enabling medicinal products to be approved for use in patients more quickly and efficiently. A key role of the regulatory professional is therefore to maintain an awareness of the evolving regulatory landscape and support medicines developers in understanding and implementing the changes.
At the Cell and Gene Therapy Catapult, the regulatory affairs team plays a key role in communicating regulatory developments to developers of cell and gene based therapies (particularly Advanced Therapy Medicinal Products, or ATMPs, as such therapies are termed in Europe) through the Regulatory News section of the Cell and Gene Therapy Catapult website (https://ct.catapult.org.uk/regulatory-news). In this section of the website, you will find up to date information on new regulatory guidance, new schemes being implemented by regulatory agencies, outcomes of regulatory agency meetings, publications that impact on ATMPs, and any other news considered important to ATMP developers. This web page (https://ct.catapult.org.uk/regulatory-news) also enables us to promote news or events from various organisations we work with. As well as the website, the latest news is also be tweeted by us using the Twitter hashtag #RegulatoryNews @CTCatapult (https://twitter.com/CTCatapult), and is published on LinkedIn (https://www.linkedin.com/company/cell-therapy-catapult?trk=company_logo).