Developers looking to bring their products to the European Union are often unaware of the different pathways open to them to get regulatory support. The European Medicines Agency (EMA) offers several initiatives to support innovators. However, there is some nuance to understanding which of these might be right for a developer, and at what stage […]
In the field of rare disease innovation, there has been a tendency to put off planning for the EU, perhaps due to concerns over the requirements or uncertainty as to how to navigate its complex, multi-national landscape. This has, unfortunately, led many sponsors to see “Europe as a problem for later” (or “a problem for […]
Innovators from markets outside the EU often have many questions about what to expect with the European Medicines Agency (EMA). For US sponsors with rare disease products, both significant and subtle differences can be a minefield when seeking EMA approval. 1. Navigating 27 markets and standards of care First and foremost, while there have been […]
Meeting requirements for Chemistry, Manufacturing and Control (CMC) is complex for any drug developer, but is even more so in the rare disease space. These challenges are further compounded for non-EU sponsors seeking to initiate clinical trials in Europe where the differences in requirements and expectations from their home market are often not well-understood. Manoeuvring […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]