ABPI news: March 2006

We all recognise that the pace of activity in the field of pharmaceutical legislation and guidance is increasing and it is always valuable to have an indication of the potential future activities that the regulators foresee.

In this respect the proposed activities of the Working Parties of the CHMP always make interesting reading. This year's programme for the CHMP Quality Working Party was published at the beginning of the year (available here) and sets out that body's aspirations for this year.

It promises to be a busy year for all concerned.

As may be expected, there will be a lot of activity related to developing or updating quality guidelines and particular reference is made to the possible need to review various CHMP quality guidelines in the light of ICH guideline Q8 (Pharmaceutical Development) and Q9 (Quality Risk Management).

In tandem with this will be co-operation with GMP inspectors to facilitate the introduction of new approaches to manufacturing and control methodologies (Process Analytical Technology (PAT)) through the EU PAT team (see the EMEA PAT webpage).

In addition, there will be ongoing development of Guidelines that have already been the subject of consultation, such as those on the Pharmaceutical Quality of Inhalation and Nasal Products and on the Requirements to the Quality Part of a Request for Authorisation of a Clinical Trial.

Keeping abreast of these developments and making sure that there is a full and valuable input into them will be a priority for the industry. As things develop in these and other areas in the work of the Quality Working Party, we will return to them in this column.