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

73,000 Scientists collaborate over new COVID-19 Da…

More than 73,000 users collaborate on new online platform set up by the European Open Science Cloud Initiative, where scientists share COVID-19 data and accelerate our un...

Antiviral used to treat cat coronavirus also works…

Researchers at the University of Alberta are preparing to launch clinical trials of a drug used to cure a deadly disease caused by a coronavirus in cats that they expect ...

Roche and Regeneron collaborate to significantly i…

Roche (SIX: RO, ROG; OTCQX: RHHBY) and Regeneron (NASDAQ: REGN) announced are joining forces in the fight against COVID-19 to develop, manufacture and distribute REGN-COV...

Search for COVID-19 drugs boosted by SARS discover…

An extensive search and testing of current drugs and drug-like compounds has revealed compounds previously developed to fight SARS might also work against COVID-19. Us...

Pfizer and BioNTech share positive early data on l…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) shared additional Phase 1 safety and immunogenicity data from their ongoing U.S. study of the BNT162 mRNA-based vac...

Phase I clinical trial initiated for monoclonal an…

The first participants have been dosed in a Phase I trial of AZD7442, a combination of two monoclonal antibodies (mAbs) in development for the prevention and treatment of...

Europe's largest initiative launches to accelerate…

CARE (Corona Accelerated R&D in Europe) a new consortium supported by the Innovative Medicines Initiative (IMI) public-private partnership announced its launch to acceler...

Vitamin D deficiency may raise risk of getting COV…

In a retrospective study of patients tested for COVID-19, researchers at the University of Chicago Medicine found an association between vitamin D deficiency and the like...

Blocking cellular communication stops SARS-CoV-2

In the transmission of signals within the cell which, for example, stimulate cell growth or trigger metabolic processes, phosphate groups play an important biochemical ro...

Improving FDA's COVID-19 vaccine authorization and…

On March 28, the Food and Drug Administration (FDA) exercised its Emergency Use Authorization (EUA) authority to allow the use of hydroxychloroquine for the treatment of ...

Steroid found to improve survival of critically il…

A new international study published today has shown that treating critically ill patients with COVID-19 with the steroid hydrocortisone improves their chances of recovery...

Bayer and Informed Data Systems Inc. (One Drop) jo…

Bayer and Informed Data Systems Inc. (One Drop), a US-based digital health company, today announced that they have entered into an agreement to jointly develop digital he...