Problems with the Integration of ICH Q9 into the European Regulatory System

Problems with the Integration of ICH Q9 into the European Regulatory System

The European Medicines Agency (EMEA) is currently looking for the best way to include the document into the European regulatory system. In general, there are two common possibilities for the Agency to do this: by publishing it as a Note for Guidance, or as an Annex to the EU-GMP Guide.

Due to the various possibilities to implement ICH Q9 Quality Risk Management, the integration might make further explanatory documents necessary. During the public consultation phase, it became clear e.g. that on the one hand manufacturers are not obliged to implement Quality Risk Management, on the other hand they can get significant advantages out of the implementation. Apart from that, the principles of risk management cannot only be applied to production, but also to development and to the preparation of dossiers for marketing authorisations. Furthermore, the guideline also concerns authorities examining the quality part of dossiers as well as GMP inspections and the handling of possible quality deficiencies.
  

How can Quality Risk Management be implemented in practice? Examples for correct implementation are dealt with at the
ICH Q9 Training Course 
on 31 May to 1 June in Prague.

 
Author:
Wolfgang Heimes
on behalf of ECA

Source: EMEA web page: http://www.emea.eu.int/Inspections/docs/ICHQ9Step4QRM.pdf