The co-operation between the EU, represented by EMEA, and the US-American
FDA has again become more intensive. After the Mutual
Recognition Agreement (MRA) had been "put on the back burner",
now both sides make new efforts to harmonise the standards and guidances
and to exchange information on GMP inspections. It had been the aim of the
MRA to recognise the GMP inspections conducted by each other's
authorities. In contrast to other MRAs (e.g. that between the EU and
Canada), this agreement has never got beyond the evaluation phase.
However, in September 2004 confidentiality
arrangements were concluded between the EU (EC and EMEA) and the FDA.
The Confidentiality Arrangements establish a framework for, among other things, the possible exchange of information on advance drafts of legislation and regulatory guidance documents, as well as
non-public information related to ensuring the quality, safety and efficacy of medicinal products for human and veterinary use, including orphan medicinal products, authorised or under review both in the USA and the EU.
They include among others the following regular
exchange of information:
- On a quarterly basis, the routine exchange of a listing of agreed specific information on applications, both pre-and
- On a quarterly basis, the routine exchange of a listing of inspections (GMP, GCP and pharmacovigilance inspections) performed the previous quarter, and inspections likely to be performed during the next quarter, at a select group of manufacturing sites of interest to each party.
- On a quarterly basis, the routine exchange of a listing of the guidelines under development.
This regular exchange already began on 1 October
The consequence of this approach for EU companies is
that e.g. GMP inspections conducted by EMEA regarding medicinal products
with a marketing authorisation under the Centralised System are known to
Recent developments show a trend towards GMP
harmonisation on many levels. Guidances and inspections are more and more
brought in line. By means of the ICH Initiative, after ICH Q7A GMP for the
Manufacture of Active Pharmaceutical Ingredients, two further 'Q' guides
were launched not long ago:
- ICH Q8 "Pharmaceutical Development"
- ICH Q9 "Quality Risk Management"
Therefore, the international GMP harmonisation is
the focus of
The GMP Conference
with 4 ICH Expert Group Members as well as
representatives from FDA, PIC/S, MPA, MHRA, and EMEA. The event offers
the unique opportunity to meet the decision-makers. More information can
be found at www.gmp-conference.org.