Change Of Focus For EU Initiatives In 1996

Having spent the last several years focussing its efforts in the area of medicines control on setting up the new European Union-wide marketing authorization system, the feeling now is that the European Commission is looking for developments in other areas where legislation will be considered or proposed over the coming years.

According to the UK Medicines Control Agency, the Commission has circulated a "concept paper" setting out the case for harmonization of aspects of EU members states' arrangements for Good Clinical Practice and the control of clinical trials. The Commission's next step will be to consider comments from the member states, industry and other interested parties and then to produce proposals for legislation, probably in the fall.

The Commission has also issued a paper (doc 5608/95, available from the MCA's EuroDirect Publications Service) for comment on Legislation on Good Manufac-turing Practice and the certification of starting materials. This sets out the Commission's initial thinking, which will be developed in light of responses.