DCAT Lunchtime Forum
Speaker: Hilde Boone, Pharm, MSc, EMA Liaison Official at the U.S. FDA
Presented during DCAT Week ’10 at the Waldorf-Astoria Hotel, NYC on 3/18/10
At the DCAT Lunchtime Forum, the new European Medicines Agency liaison official to the U.S. FDA, Hilde Boone, discussed the EMA’s long term international vision, and the framework for and key areas of collaboration between the FDA and the EMA. This DCAT member-only program provided participants with a unique opportunity to be among the first to hear how this new bilateral exchange agreement will affect the pharma industry.
Ms. Boone explained that the EMA’s long term international vision focuses on creating synergies through communication, collaboration and cooperation with international regulatory partners to support a global approach to authorization and supervision of medicines that uses existing partnerships and regulatory tools and relies on local regulators.
The framework for cooperation between the EMA and FDA is defined by a confidentiality arrangement that outlines the processes for sharing of draft guidance and legislation, non-public documents, and pharmacovigilance and inspection information, as well as training, education and staff exchanges.
The key areas for collaboration between the agencies include product development, product evaluation and surveillance, and product manufacturing and compliance.
Product development:
The focus in this area is on pediatric medicine, biomarkets and pharmacogenomics, and parallel FDA-EMA scientific advice.
Pediatric medicine – The aim in this area is to create global development plans
compatible for both agencies, that will avoid exposing children to unnecessary
trials and reduce administrative and regulatory burden.
Biomarkets and pharmacogenomics – The goal is to share information and expertise
in new areas with the aim of creating scientific consensus and common requirements,
facilitate global development and make safer medicines available earlier for the
right patient.
Parallel FDA-EMA Scientific Advice – The objective is to increase dialogue between the
agencies and sponsor from the early stages of development, exchange views and share
expertise, and optimize and facilitate global development while meeting both
agency’s requirements.
Product Evaluation and Surveillance:
The awareness of ongoing evaluations will create opportunities for discussion and exchange of views, including advance notice of important regulatory action, and foster exploration of post-approval commitments and risk minimization measures that meet both agencies’ requirements.
Product Manufacturing & Compliance:
Planned collaboration in the area of GMP inspections, include joint FDA-EMA inspections of manufacturing sites in the United States and European Union, as well as a pilot project for API inspections in third countries. Collaboration will save resources and decrease duplicate inspections, and increase the number of API sites inspected outside the agency’s territory. A GCP inspection pilot program, begun in September 2009, will lead to more efficient use of inspection resources, broader coverage of sites and enhanced consistencies in inspection approaches.
Ms. Boone concluded by saying that the EMA is committed to expanding its international activities, by strengthening its existing collaboration with the United States, Japan and Canada and extending into other territories, including China, India and Russia.
With many collaborative projects underway, the success of the FDA and EMA collaboration is based on mutual confidence, experience due to regular exchanges, commitment from both parties, as well as cooperation and pragmatism from stakeholders.
This cooperation will lead to more efficient use of resources, contribute to increased consistency and predictability in regulatory approaches, and support a global approach to the development, authorization and supervision of medicines, thus leading to the availability of safe and effective new medicines, as early as possible.