U.S. And E.U. Regulators Co-operate on Assessment of Personalized Medicine
The European Commission, European Medicines Agency and the U.S. Food and Drug Administration issued a joint statement on 31 May, stating that they had agreed to a procedure for joint FDA EMEA briefing meetings with sponsors following voluntary submission of genomic data.
Much of pharmacogenomic data are of an exploratory nature and not required to be submitted to health authorities in most cases. However, voluntary submissions of such data is encouraged as a means to ensure that regulatory authorities are familiar with the issues arising from the integration of pharmacogenomics in drug development and to ensure that industry has an opportunity to hear scientific perspectives from the regulatory authorities. These joint voluntary submissions are important for regulatory agencies to ensure that evolving policies are based on the best science, to help in the development of common approaches to genomics in drug development, and to facilitate the use of pharmacogenomic tests during global drug development.
The procedure has been agreed to within the scope of the confidentiality arrangements between the EC/EMEA and the FDA and is based on prior experience with joint briefings.
Voluntary genomic data submission packages will be reviewed by the FDA’s Interdisciplinary Pharmacogenomic Review Group (IPRG) and the EMEA Pharmacogenetics Working Party (PGWP). The data is subject to guiding principles on processing joint FDA EMEA voluntary genomic data submissions (VGDSs).
The confidentiality arrangements allow the EC/EMEA and the FDA to exchange information as part of their regulatory processes. The types of information covered by the arrangements include legal and regulatory issues, scientific advice, orphan drug designation, inspection reports, marketing authorisation procedures and post-marketing surveillance. The arrangements cover medicinal products that are subject to evaluation or authorised under the centralised procedure as well as medicinal products that are authorised at national level by the EU Member States and that are subject to official European Community arbitrations and referral.
Reuters reported that:
A spokeswoman for Europe’s medicines watchdog said the cooperation agreement with FDA was not focused on any particular disease area but was designed to help the development of coherent policies across the board.
“It’s about giving everybody a chance to get up to speed on this issue,” she said.
I am pleased to see this co-operation between E.U. and U.S. regulators. While I cannot claim any expertise in medicine, personalized or otherwise, it is resonable to assume that this sharing of knowledge across the Atlantic will serve to assist the development of the regulatory process for personalized medicines.
Knowledge shared is knowledge increased; every step along the way is one step closer to the finish.
