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European Directive 2001/83/EC relating to medicinal products for human use was revised by Directive 2004/27/EC (published in April 2004). This revision foresees the implementation by 1 November 2005 at the latest of Good Manufacturing Practices according to ICH Q7A (International Conference on Harmonisation) for all the Active Pharmaceutical Ingredients.
Directive 2004/27/EC also foresees the publication of another Directive containing a positive list of risk excipients that will have to follow similar GMPs. For the time being, the list is under discussion between the European Commission and industrial associations. In the meantime, the GMP reference system for those excipients remains undecided.
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