Medicines Regulators on Both Sides of the Atlantic Confirm Commitment to Cooperation on Medicines
The European Commission (EC), the European Medicines Agency (EMEA) and the United States Food and Drug Administration (FDA) have affirmed their commitment to regulatory cooperation and to intensifying their interactions in several new areas.
Medicines Regulators on Both Sides of the Atlantic Confirm Commitment to Cooperation on Medicines
The European Commission (EC), the European Medicines Agency (EMEA) and the United States Food and Drug Administration (FDA) have affirmed their commitment to regulatory cooperation and to intensifying their interactions in several new areas.
Meeting in London on 30 September and 1 October 2008 for the annual review of cooperative activities undertaken under the scope of their
confidentiality arrangements, the European Union and United States authorities agreed to expand cooperation in the areas of advanced-therapy medicines and nanotechnology-derived medicinal products, as well as on the exchange of pharmacovigilance information. This builds on achievements made previously in areas such as oncology, vaccines, orphan medicines and paediatric medicines.
Notable progress has been made on implementing the Transatlantic Administrative Simplification initiative since its launch in November
2007, particularly in the areas of inspections, qualification of biomarkers, paediatrics and advanced-therapy medicines.
The EU–US confidentiality arrangements on medicines for human use were first signed in September 2003 and extended for a further five years in
September 2005. Similar arrangements covering veterinary medicines, which allow the EC/EMEA and the FDA to exchange confidential information as part of their regulatory processes relating to the veterinary sector, were signed in May 2008.
Having been in place for five years, both sides concur that the transatlantic cooperation activities continue to be successful in protecting and promoting global human and animal health, reducing the regulatory burden and costs so that innovative medicines can be brought
to patients in a timely manner, while also allowing critical safety information about medicines to be shared between the US and EU regulatory authorities.
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
FDA-Approved Gene Therapy Beqvez Shows Sustained Efficacy, Safety in Long-Term Hemophilia B Trial
April 17th 2025Beqvez (fidanacogene elaparvovec), an FDA-approved one-time gene therapy for hemophilia B, demonstrated sustained factor IX expression, low bleeding rates, and a favorable safety profile over long-term follow-up.
