Addressing regulatory issues is an integral part of bio medicinal development, and their importance will only continue to increase for the foreseeable future. The EATRIS regulatory service and support centre is available to help guide you through this complex world, especially for complex and hybrid products for which clear regulatory guidance may not be available. Early assessment of the potential requirements may prevent unnecessary project delays, reduce extra costs and most importantly prevent penalties resulting from non-adherence to legal requirements.
EU Regulatory Framework and Current Challenges in Bio Medicine
The regulatory environment in the EU is very complex, is in continual development and despite all recent efforts, still fragmented. Pan-EU projects need to be prepared to identify different national needs not only for medicinal products but for medical devices, blood derivatives, tissues and cells, including their utilization in clinical trials. Highly sophisticated products including ATMPs, nanotechnologies, emerging technologies or m-health are creating new entities not fitting the current regulatory concept. Therefore, the need for better knowledge as well as standardization is continuously increasing.
How can we help you?
Through a combination of in-house and external partnerships with a range of regulatory experts and groups, EATRIS can provide regulatory support for most types of product. Our range of services include:
- Expert opinion
- Orphan Drug Designation and Scientific Advice application at the EMA
- Pre-clinical and clinical plan development
- Informal scientific advice with selected national competent authorities, for highly complex projects
- Access to EATRIS Regulatory Database (free of charge) that contains information about the regulatory requirements, guidelines and legislations from 27 EU countries (as well as Norway, Switzerland, Turkey and Israel) regarding drug and medical device development derived from the application of European legislation.
Don’t hesitate to get in touch for any further information on how EATRIS can support you through the regulatory maze. Use the form below or go to our Contacts page.