SME status in the EU

Are you a small or medium-sized enterprise (SME) established in the European Union (EU)/ European Economic Area (EEA)? If so the European Medicines Agency (EMA) provides incentives and support for SMEs developing medicines for humans. Criteria The criteria are:   Category Head count Annual turnover Or balance-sheet total Medium-sized < 250 ≤ € 50 m […]

Clinical Trials Regulation in the EU

Clinical Trials Regulation in the EU The Clinical Trials Regulation (Regulation (EU) No 536/2014) comes into application on 31 January 2022 and the Clinical Trials Information System (CTIS) is due to go live on this date.  What are the aims of the new Clinical Trials Regulation? To create an environment that is favourable to conducting clinical trials in […]

International Expansion

We welcome Sue Allen, Senior Regulatory Affairs Consultant, to discuss the practical considerations of international expansion and the questions that should be asked during the planning and execution stages of licencing your pharmaceutical products globally. As developed markets continue to stagnate, emerging markets are becoming even more important as a source of revenue growth for […]

Brexit – CAP Renewals

Today we’re looking at renewals submitted for Marketing Authorisations (MAs) granted through the Centrally Authorised Procedure (CAP). For the basics on renewals please see my previous blog. A quick recap on how CAP licences will be handled – also see my previous blog on this subject: All existing MAs authorised through the CAP will automatically be […]

Regulatory Intelligence

Here we introduce a topic that can be seen as somewhat onerous, however it is vital for the compliance of both products and processes within the pharma industry. The Drug Information Association (DIA) defines Regulatory Intelligence (‘Reg Intel’) as; the act of gathering and analysing publicly available regulatory information. Life Science professionals routinely access Regulatory […]