28/29 September 2021
GMP News No. 417
5 May 2004
EU Publishes the New EUDirective 2004/27 -
We had already announced the long-awaited Directive in our GMP News of 31 March 2004. At that time, the Directive had not yet beenpublished officially. This has now been done on 3 May (together withseveral translated versions). As we had said, the Directive is maderetrospective to 31 March 2004. In the following we will repeat the mostimportant changes for the GMP-regulated environment:
The suggestions for change mainly concern finished medicinal products(the topics are marketing authorisation, clinical trials,pharmacovigilance). However, some of the amendments are also relevant toAPI manufacturers and can be summarised like this:
Even though this Directive requires API manufacturers to comply withthe GMP principles, the supervisory authorities do not have to conductinspections, as in the case of medicinal products. (The English originalsays: "Thecompetent authority may carry out inspections..." and not "...must...")So there is no legal basis for a national operation ordinance for APImanufacturers either.
On the other hand, there is increasing pressure on the APImanufacturers to follow the GMP principles because the pharmaceuticalcompanies will have to enforce this requirement against their APIsuppliers.
Pharmaceutical API companies will thus be forced to comply with theprinciples of Annex 18 to the EU GMP Guide (ICH Q7A "GoodManufacturing Practice Guide for Active Pharmaceutical Ingredients")in the manufacture of their APIs if they want to stay in business.