Regulatory Environment
The EU's medicines marketing authorisation system ensures that the medicines approved for use in the EU meet stringent criteria of safety, efficacy and quality. However, while ensuring that these criteria are safeguarded, it is also important to make sure that the process is as streamlined and easy-to-use as possible.
Under the EU's new pharmaceutical legislation, all biotech derived medicines and all "orphan" drugs are obliged to use the Centralised approval procedure (the European Medicines Agency).
Via the Regulatory & Technical Affairs Committee, EBE contributes to the development of new regulatory frameworks, guidelines and standards of relevance to biopharmaceutical companies operating in Europe and promotes the exchange of good practices fostering the development of safe, efficacious and high-quality medicines.
Regulatory hurdles fall particularly hard on smaller companies, and many of the biopharmaceutical companies in Europe are Small & Medium-sized Enterprises (SMEs). Therefore, EBE works together with the authorities to ensure that the system is as easy to use and as supportive of SMEs as possible.
The EBE Regulatory & Technical Affairs Committee is currently working on projects such as:
- Regulatory Intelligence on draft Guidelines/Regulations
- Technical discussions around Biosimilars and Advanced Therapies (gene therapy, somatic cell therapy, tissue-engineered products)
- Implementation of the Clinical Trials Directive
- Implementation of the New Pharmaceutical Legislation
- Implementation of the Regulation for Medicines for Paediatric Use
- Review of the Variations Regulations
- Organisation of Technical & Regulatory Workshops and Training sessions