Why an experienced SME regulatory consultant is key for non-EU companies

For any non-EU small and medium-sized pharmaceutical company, having a gateway to the European market is crucial. Those companies seeking to take advantage of the European Medicines Agency’s (EMA) SME status will need to work through an EU registered third party, ideally an experienced SME regulatory consultancy. The benefit of having a consultancy for the […]

What is SME Status and how does it benefit innovators?

The European Medicines Agency offers a significant and unique benefit to Small and Medium-Sized Enterprises developing medicines for human or veterinary use. The purpose of SME Status is to promote innovation and the development of new medicines. The SME Regulation, which was established in 2005, led to the creation of the SME office which “provides […]

Data transparency: Why it’s important to post trial results on EudraCT or CTIS

While there is much focus on transparency in the Clinical Trial Regulation, it’s important that sponsors understand their data transparency obligations for trials that were conducted in the EU and that will be wrapped up under the Clinical Trial Directive. Sponsors are expected to ensure results from those studies that do not need to transition […]

Allowing time for the legal rep evaluation in the move to CTR

The Clinical Trials Regulation (CTR) has added some complexities for non-EU sponsors, including with regard to the role of the legal representative. Sponsors who are not based in the EU must appoint a representative within the EU to act as a legal representative. While this has always been a requirement, under the CTR the legal […]

Understanding what’s required to work in CTIS

Before making a submission to the CTIS, sponsors transitioning clinical trials previously approved under the EU Clinical Trials Directive must take several preparatory steps. These can be time consuming and are not always well-understood so it’s important that you take time to prepare yourself before making the transition. To get started, you will need to […]

The multiple steps involved in the transition to CTR

There is a lot for sponsors to think about before they can even start transitioning their clinical trials to the Clinical Trial Regulation (CTR) and accessing the various portals. First, there are practicalities of how they will manage their ongoing studies to ensure they are suitable to transition to CTR. While this is something most […]