ABPI news: December '05 - January '06

It's that time of the year again. The time to look back and take stock as to what we achieved last year and what we are going to do this.

This time last year we were looking forward to the implementation of the new medicines legislation set out in Directive 2004/27/EC with provisions relating, among others, to the application of Braille, the need for GMP for APIs, and the application of GMP for some excipients. A year on and into the third month of the application of the legislation we still have significant questions surrounding the exact requirements of the Directive and the variety of nuances of its implementation in different member states. In the case of excipients we are still waiting for the secondary legislation that will implement the provisions of the Directive relating to such substances.

There obviously remains much to be done in 2006 in clarifying these requirements, and most importantly in seeking harmonisation of requirements throughout the 25 member states. As with the clinical trials Directive, one of the major frustrations of manufacturers is this apparent lack of consistency of application across the Community. In an increasingly international market this causes major problems and would seem to be contrary to the prime intention of any Directive: harmonisation within the single market.

On the chemicals side, it seemed likely at the time of writing that a final political agreement would be achieved on the REACH Regulation by Christmas with final drafting and adoption in the New Year. No doubt a large part of next year and the following years will be spent looking at the practical application of the new Regulation and the day-to-day implications of it for pharmaceutical manufacture.

A busy year gone and no doubt an equally busy, if not busier, one to come.

In the meantime, I hope you have had a happy and peaceful festive season and have suitably recharged the batteries ready for the challenges of the New Year.