22 October 2020
ICH Q11 - A New Guideline for the Development of APIsIs Being Created
Which issues are meant to be harmonised and regulated throughICH Q11?
The requirements on the information about the manufacturingprocess of active pharmaceutical ingredients to be included in the dossier for amarketing authorisation differ from one region to another and confront the drugmanufacturer with the problem of having to create several versions of the CTDsections S 2.2 - S 2.6 when applying for a marketing authorisation. The answerto the question which data on API production a registration authority expects and in how much detail they should be described inthe dossier is either not clear or differs between countries. In addition, divergentrequirements on APIs manufactured by chemical synthesis and biotechnologicalmethods are the cause for further unnecessary complexity. This leads to aharmonisation gap, which is intended to be filled by means of ICH Q11.
The description of and grounds for the development of an activeingredient and its manufacture must be oriented towards the principles of ICHQ8, Q9 and Q10. The authors of the concept paper consider the following aspectsof the development of APIs to be particularly in need of harmonisation:
This guideline is meant to reduce efforts not only on the partof the pharmaceutical and API industries; the harmonisation of the requirementsin connection with the authorisation process should also bring benefits to theassessors from the registration authorities.
ICH Q11 is currently in "Step 1", called the consensus-buildingphase. The intermediate steps in the harmonisation schedule of this guidelineleading to "Step 2" are as follows:
It will be interesting to get to know the detailed requirementsof the guideline; however, a consensus guideline can hardly be expected beforethe beginning of 2010.
The Q11 Guideline can be found here.