EU Publishes the New EU Directive 2004/27 - Consequences for the GMP-regulated Environment

GMP News No. 417

5 May 2004

EU Publishes the New EUDirective 2004/27 -
Consequences for the GMP-regulated

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:

  • Manufacturers of medicinal products may only use APIs that have beenmanufactured according to the GMP principles
  • The competent supervisory authority can conduct inspections at thepremises of API manufacturers if there is reason to doubt their GMPcompliance
  • The European Pharmacopoeia Commission may ask the EU Commission orthe European authority EMEA to request an inspection if the startingmaterial is the subject of an API monograph
  • In case an inspection at the premises of an API manufacturer leadsto the detection of non-compliance, the information is recorded in a Communitydatabase

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.

Dr Gerhard Becker



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