ICH Q11 - A New Guideline for the Development of APIs Is Being Created
Which issues are meant to be harmonised and regulated through ICH Q11?
The requirements on the information about the manufacturing
process of active pharmaceutical ingredients to be included in the dossier for a
marketing authorisation differ from one region to another and confront the drug
manufacturer with the problem of having to create several versions of the CTD
sections S 2.2 - S 2.6 when applying for a marketing authorisation. The answer
to the question which data on API production a registration authority expects and in how much detail they should be described in
the dossier is either not clear or differs between countries. In addition, divergent
requirements on APIs manufactured by chemical synthesis and biotechnological
methods are the cause for further unnecessary complexity. This leads to a
harmonisation gap, which is intended to be filled by means of ICH Q11.
The description of and grounds for the development of an active ingredient and its manufacture must be oriented towards the principles of ICH Q8, Q9 and Q10. The authors of the concept paper consider the following aspects of the development of APIs to be particularly in need of harmonisation:
This guideline is meant to reduce efforts not only on the part of the pharmaceutical and API industries; the harmonisation of the requirements in connection with the authorisation process should also bring benefits to the assessors from the registration authorities.
ICH Q11 is currently in "Step 1", called the consensus-building phase. The intermediate steps in the harmonisation schedule of this guideline leading to "Step 2" are as follows:
It will be interesting to get to know the detailed requirements of the guideline; however, a consensus guideline can hardly be expected before the beginning of 2010.
The Q11 concept paper can be found here: