European Medicines Agency and U.S. Food and Drug Administration extend confidentiality arrangements

The European Medicines AgencyThe European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have extended their confidentiality arrangements related to medicinal products for human and veterinary use, following the positive experience gained since the initial arrangements were signed in September 2003. This cooperation will now continue indefinitely without the need for further renewal.

The confidentiality arrangements allow both Agencies to exchange confidential information as part of their regulatory and scientific processes. Their aim is to promote public and animal health and to protect European and U.S. patients. The types of information covered by the arrangements relate to scientific advice, orphan drug designation, paediatric development, good manufacturing practice (GMP) and good clinical practice (GCP) inspection planning and reports, marketing authorisation procedures and subsequent changes to the marketing authorisations together with post-marketing surveillance.

The confidentiality arrangements cover medicines that are subject to evaluation or authorised under the centralised procedure as well as medicines that are authorised at national level by the EU Member States and that are subject to official European Community arbitrations and referrals.

These new commitments are based on the achievements of the previous arrangements between the EMA, the European Commission and the FDA.

The current implementation plan remains in force.

Most Popular Now

Regorafenib to be tested in brain cancer patients …

Bayer announced that the regorafenib arm of the platform trial "GBM AGILE" (Glioblastoma Adaptive Global Innovative Learning Environment) opened for enrollment in the US ...

Sanofi and Google to develop new healthcare Innova…

Sanofi and Google will establish a new virtual Innovation Lab with the ambition to radically transform how future medicines and health services are delivered by tapping i...

Bristol-Myers Squibb provides update on pending me…

Bristol-Myers Squibb Company (NYSE: BMY) today provided an update on the approval process and timeline for the Company’s pending merger with Celgene Corporation (NASDAQ: ...

Artificial DNA can control release of active ingre…

A drug with three active ingredients that are released in sequence at specific times: Thanks to the work of a team at the Technical University of Munich (TUM), what was o...

LEO Pharma completes the acquisition of Bayer’s pr…

LEO Pharma and Bayer announced today the achievement of the relevant closing conditions to allow the transfer of Bayer’s global prescription dermatology business to LEO P...

Pathogen engineered to self-destruct underlies can…

A team of investigators has developed a cancer vaccine technology using live, attenuated pathogens as vectors. A feature of the vaccine causes these bacteria to self-dest...

Novartis successfully completes acquisition of Xii…

Novartis today announced that it has completed its acquisition of Xiidra® (lifitegrast ophthalmic solution) 5%, the first and only prescription treatment approved to trea...

How gastric stem cells fight bacteria

Stem cells are not only key players in tissue regeneration, they are also capable of taking direct action against bacteria. This is the finding of a study conducted by re...

New study showing drug prolongs life for patients …

Women with ovarian cancer who have undergone four or more rounds of chemotherapy typically haven't had much hope that another treatment option will lengthen their lives i...

Pfizer completes acquisition of Therachon

Pfizer Inc. (NYSE: PFE) announced the successful completion of its acquisition of the privately held clinical-stage biotechnology company Therachon Holding AG. Under the ...

Sports playbook helps doctors predict cancer patie…

In this season of global soccer competitions and hotly contested political primaries, bookies and pundits are scouring every evolving scrap of information and sifting thr...

FDA seeks public feedback on new drug approval tra…

Today the U.S. Food and Drug Administration issued a Federal Register notice, New Drugs Regulatory Program Modernization: Improving Approval Package Documentation, to ope...