Medicine regulatory agencies in the EU, US and Australia have been successfully collaborating for some time now with regards
to GMP inspections of API manufacturers, but now they are seeking to further expand this international effort by looking to
include additional partners. The initial pilot scheme ran from 2008 to 2010 and involved the sharing of inspection plans,
reports and information concerning API manufacturers, as well as several joint inspections. The project was so successful
that cooperation in these areas has continued.
The current partners have agreed that clear criteria need to be established for any new participant to be accepted, as well
as to maintain ongoing participation. To this end, the EMA has published a document entitled Programme to rationalise international GMP inspections of active pharmaceutical ingredients/active substances manufacturers
that outlines the terms of reference and procedures for authorities to participate in the programme. Some of the points mentioned
are that the reference GMP standard for inspections will be ICH Q7 and that participants will be responsible for ensuring
that the appropriate confidentiality arrangements are in place. In addition, if an inspection results in regulatory action
or license suspension, this decision will be shared with the other authorities.
However, if a potential new partner does not meet the criteria listed in the document, they may still be accepted into the
programme for the benefit of global health. In addition, nonparticipating authorities may still request access to inspections
information. In this case, information sharing will be facilitated in a way that does not compromise any confidential information.
The WHO has already agreed to become a new partner in the collaboration through its Prequalification of Medicines Programmes,
which aims to make quality priority medicines available to those who need them and includes evaluation, inspection and quality
Who will be next to take part?