22/23 April 2021
GMP News No. 552
10 May 2005
EMEA and FDA Intensify Their Co-operation
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:
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:
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.