How does IMCD support our partners when new regulations are announced?
Anne-Claire: Having a broad network within IMCD, our country teams can support and keep up with local regulations. We provide our customers with technical and regulatory support for APIs both prior to registration and in the post-approval stage. We support them in getting the required documentation from manufacturers, but also assist our manufacturers when they need it, as regulations are different in every country. Some manufacturers may be very aware of the regulations in big regions like the US or the European Union, but sometimes they need more assistance in countries with less experience in international dealings. In these cases, we thoroughly explain the registration needs or even support with document improvements as per specific requirements. Of course, we are monitoring the evolution of regulations, so that when there is something new coming, we are ready to answer any questions that may arise.
This has been the case with the new Certificate(s) of Suitability (CEP 2.0), for which the transition period started on June 1st, 2023. The EDQM (European Directorate for Quality of Medicine & Healthcare) already disclosed the changes and gave examples. This will have an enormous impact on all our customers in Europe and all countries where CEP is recognised, as well as on most of our API suppliers worldwide. As such, we are closely following the situation and we are ready to support our partners, especially during the transition period and beyond.