ABPI News: August 2005

For some years concern has been expressed by industry as to the somewhat opaque procedure by which EMEA guidelines and associated documents were derived. Aware of this, the Agency published a consultation document last year that set out proposals for making the process more transparent and inviting the views of industry.

While welcoming the EMEA initiative in moving towards greater transparency, industry was disappointed that the proposals did not go further in encouraging industry input at an earlier stage in the guideline derivation process. The final guideline derivation procedure was published on EMEA's website (www.emea.eu.int/pdfs/human/regaffair/ 2414304en.pdf ) in June of this year, and formally comes into force in September.

The new procedure describes the various different types of guideline that form part of the European pharmaceutical legislative system and describes their respective status. Other non-guideline documents are also discussed.

It also sets out the various stages of the derivation process for guidelines. Essentially this covers determination of need for a guideline; appointment of a rapporteur; concept paper; first drafting; consultation; final drafting and adoption and implementation.

Unfortunately, the new procedure still does not formalise a mechanism for industry input into the content of the guideline over and above the consultation procedure, although there is now a requirement for EMEA to report on the nature of comments received and to explain why they have or have not been accepted. Indeed, it has done so in respect of the consultation on the procedure (available on the EMEA website at: www.emea.eu.int/pdfs/human/regaffair/12581704en.pdf). However, it is welcomed that EMEA can call meetings with relevant parties on specific draft guidelines if it deems it appropriate.

It will be interesting to monitor the success of the new formalised procedure and review its effectiveness some time in the future.