Post-genomic research is rapidly elucidating the complex mechanisms underlying human medical conditions, facilitating the equally rapid identification of effective routes for biopharmaceutical intervention. Consequently, a substantial and quickly growing number of potential break-through medicines are under development. Many of these novel medicines are designed by biomedical and biotechnological approaches, but do not necessarily fit within the current definition of biopharmaceuticals – as applied e.g. in the Council Regulation creating the Centralised Procedure (EEC No. 2309/93, as amended) – or within the scope of the current guidances, directives and regulations for clinical testing and approval. The rational and accelerated development and approval of such new, safer, more effective biopharmaceutical drugs can be greatly enhanced and improved by the development of supporting European policies and their timely implementation. In the context of the European Union's LifeSciHealth Priority, the proposed Working Group – composed of key stakeholders and experts across Europe, including participants from industry, regulatory authorities, and academia – will be able to provide effective support action on definitions, regulations and guidelines for novel biopharmaceuticals.

Regulatory Affairs is one of the most important disciplines accompanying drug development from tube to market. Regulations governing research, development and marketing of medicinal products are nowadays developed in close co-operation between authorities and pharmaceutical industry. Methods and technology in pharmaceutical biotechnology are advancing much faster than the respective regulations. In the EU as well as elsewhere – and also at ICH (International Conference on Harmonisation of the technical requirements for drug registrations) – we must take into account, that the development of guidances, directives and regulations takes a long time before they come into force. In the mean biotechnology based companies which develop their new drugs with new technologies, have a regulatory "black box" concerning the design of their development program.

Therefore, the key objectives of this Working Group are to

• develop a regulatory competence to support biotech companies in designing their regulatory strategies and development programs
• identify regulatory issues of biotech products which are not clearly covered by existing legislation and recognise the need for the development of new guidances and laws
• discuss a recognised need in case studies within the group, with other relevant organisations and the authorities - discuss and comment draft regulations ( eg. from ICH step 2)
• establish close relations to the European Union authorities, the ICH and others and exchange experience on a regular base - become acknowledged by these authorities as an "interested party" which will be invited to comment the development of new regulations before they come into force