To date there has only been one GMP guideline that has been harmonised in
the US, Europe, and Japan: ICH Q7A "Good Manufacturing Practice Guide
for Active Pharmaceutical Ingredients." Now, ICH is getting further
"Q" Guidelines under way. We have reported about the background
for this initiative in our GMP News of 6 August
2003. Due to its reforming "cGMP for the 21st Century"
initiative, the US-American FDA had put the introduction of a risk-based GMP
approach as well as the harmonisation of GMP requirements on the agenda. The
International Conference on Harmonisation, which consists of representatives
of the triad's authorities (i.e. FDA in the US, EMEA in the EU, and MHLW in
Japan) and pharmaceutical associations (PhRMA, EFPIA, and JPMA), has now
reacted to the initiative. Apart from these members, Canada, the World
Health Organisation (WHO), and the European Free Trade Area (EFTA,
represented by Dr Spang of the Swiss authority Swissmedic) participate in
ICH as observers.
On the occasion of the ICH6 Conference in Osaka on 15 November, it has now
been decided to develop the guidelines:
- ICH Q8 Pharmaceutical Development -
Quality by Design
- ICH Q9 Risk Management
to harmonise them and to implement them in
the regions USA, Europe, and Japan. Establishing an ICH standard in the
triad requires the following steps:
| Step
1 |
Consensus
Building |
| Step
2 |
Start
of Regulatory Actions |
| Step
3 |
Regulatory
Consultation
At this point the document is
already published: in Europe as a Draft CPMP Guideline by EMEA, in the
US as a Draft Guidance in the Federal Register by FDA, and in Japan as
a Draft Guidance by MHLW. |
| Step
4 |
Adoption
of a Tripartite Harmonised Text |
| Step
5 |
Implementation |
Owing to the planned publication, it is
probable that in the future ICH will not only provide for the worldwide
harmonisation of requirements regarding the marketing authorisation (like
the Common Technical Document), but also of quality- and GMP-relevant
documents.
In order to do justice to the importance of
these topics, ECA has been focussing its attention on them for some time
now.
|
