EMEA and FDA Intensify Their Co-operation

 
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 post-authorisation
• 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 2004!

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 the FDA.

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.

Author:
Oliver Schmidt
CONCEPT HEIDELBERG