EMEA finalises EU pharma guideline procedure
designed to make the process for the development, consultation,
finalisation and implementation of pharmaceutical guidelines
clearer.
The response by Europe's main pharmaceutical regulatory body, aims to tighten up and clarify new guidelines, keeping in line with the European Union's harmonisation activities with Japan, US and other international partners through the international conferences on harmonisation for human and veterinary medicines (ICH and VICH).
The procedure was drawn up in an attempt to give guidance to applicants and/or sponsors planning the overall pharmaceutical product development. In addition, they were intended to facilitate the preparation of applications for marketing authorisations by the pharmaceutical industry.
Pharmaceutical guidelines provide essential information to be taken into account in the research and development of new medicines. Based on the most up-to-date scientific knowledge they are a part of the Agency's work within the European Union pharmaceutical regulatory system.
Indeed, with the recent issues concerning clinical trial procedures and safety concerns involving blockbuster drugs, the procedures could well have been devised as a response to these events.
The EMEA also said that the procedure was important in assessing the impact for interested parties and competent authorities. In addition, the new procedure related to how decisions were taken on whether new guidance was needed.
The improvements to the current guideline procedures are part of the Agency's response to the transparency consultation exercise carried out in 2003. A draft version was released for consultation in September 2004.
The draft: "Procedure for European Union guidelines and related documents within the pharmaceutical legislative framework," is available on the EMEA website.
