EMEA reviews its guidelines procedures

Published: 7-Oct-2004

The European Medicines Agency (EMEA) is revamping how it frames detailed guidelines for the pharmaceutical industry, such as those on good manufacturing practice and residue limits, and wants companies to comment on its proposed transparent procedures.


The European Medicines Agency (EMEA) is revamping how it frames detailed guidelines for the pharmaceutical industry, such as those on good manufacturing practice and residue limits, and wants companies to comment on its proposed transparent procedures.

EMEA especially intends to check in future whether it should issue guidelines at all before writing detailed rules. It said: 'A consistent and transparent approach is proposed that will include an assessment of the impact on interested parties and competent authorities.'

As befits developing a consultative system, EMEA has published a draft system (see http://www.emea.eu.int/pdfs/human/regaffair/2414304en.pdf). Comments should be sent to guidelinesconsultation@emea.eu.int by 8 December. A final document should be issued early next year.

  

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