ICH Q8 and ICH Q9 Coming Soon!

GMP News No. 369

GMP News
10 December 2003

ICH Q8 and ICH Q9Coming Soon!

To date there has only been one GMP guideline that has been harmonised inthe US, Europe, and Japan: ICH Q7A "Good Manufacturing Practice Guidefor Active Pharmaceutical Ingredients." Now, ICH is getting further"Q" Guidelines under way. We have reported about the backgroundfor this initiative in our GMP News of 6 August2003. Due to its reforming "cGMP for the 21st Century"initiative, the US-American FDA had put the introduction of a risk-based GMPapproach as well as the harmonisation of GMP requirements on the agenda. TheInternational Conference on Harmonisation, which consists of representativesof the triad's authorities (i.e. FDA in the US, EMEA in the EU, and MHLW inJapan) and pharmaceutical associations (PhRMA, EFPIA, and JPMA), has nowreacted to the initiative. Apart from these members, Canada, the WorldHealth Organisation (WHO), and the European Free Trade Area (EFTA,represented by Dr Spang of the Swiss authority Swissmedic) participate inICH as observers.
On the occasion of the ICH6 Conference in Osaka on 15 November, it has nowbeen decided to develop the guidelines:
  • ICH Q8 Pharmaceutical Development -Quality by Design
  • ICH Q9 Risk Management

to harmonise them and to implement them inthe regions USA, Europe, and Japan. Establishing an ICH standard in thetriad requires the following steps:

Step2Startof Regulatory Actions
At this point the document isalready published: in Europe as a Draft CPMP Guideline by EMEA, in theUS as a Draft Guidance in the Federal Register by FDA, and in Japan asa Draft Guidance by MHLW.
Step4Adoptionof a Tripartite Harmonised Text

Owing to the planned publication, it isprobable that in the future ICH will not only provide for the worldwideharmonisation of requirements regarding the marketing authorisation (likethe Common Technical Document), but also of quality- and GMP-relevantdocuments.

In order to do justice to the importance ofthese topics, ECA has been focussing its attention on them for some timenow.

Source: PressRelease on ICH6 in Osaka

Oliver Schmidt


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