ABPI news - a busy winter ahead

With the heady days of summer rapidly fading in the memory and the first winds and rain of autumn setting in, it's time look forward to the forthcoming agenda for the industry over the coming months. A number of topics have been touched on in this column over the year and many, if not all, rumble on through the regulatory process.

On child resistance of strip and blister packaging, we still await the publication of the Medicines Control Agency (MCA) proposals for the application of BS 8404 and discussion continues in the European arena on a possible standard from the European standards body CEN. In the chemicals sector, the first European Commission proposals on legislation emanating from the White Paper on chemicals control are likely to surface over the winter – plenty to talk about there when they become available!

On the clinical trials front the finalised revision of annex 13 to the European Guide to GMP is awaited, as are details of the licensing process for manufacturing sites for clinical trials material. And still to be resolved are the issues raised in the MCA's consultation document on the possibility of pharmacists copying patient information leaflets. ABPI, together with professional organisations, will continue stress to Government and the public the absurdity of the proposals.

With all these issues ongoing it is sure to be a busy time for all involved in the manufacturing fraternity of the pharmaceutical industry, and at ABPI we shall be involved closely with the discussions on all these topics as they evolve – both at UK and European level.