Transatlantic Administrative Simplification

In Brussels on 28 November 2007, in the field of pharmaceutical regulation, the European Commission hosted the Transatlantic Administrative Simplification Workshop which was co-chaired by the European Commission and the United States (U.S.) Food and Drug Administration (FDA) and organised in collaboration with the European Medicines Agency (EMEA) and the Heads of the EU National Medicines Agencies (HMA).

Background:

This initiative had explicit support at the highest political level through the "Framework for Advancing Transatlantic Economic Integration between the European Union and the United States of America" signed by Presidents Bush, Merkel and Barroso in April 2007.

Objective of the Workshop:

The overall project objectives has been to identify opportunities for administrative simplification through transatlantic cooperation and the Workshop provided the transatlantic pharmaceutical regulatory partners a unique opportunity to hear the pharmaceutical and biotechnology industries proposals.

Outcome of the Workshop:

Numerous ideas for simplification presented by industry from both sides of the Atlantic strongly showed that there is major scope for administrative simplification through bilateral and multilateral collaboration and harmonisation. The European Commission and regulators from EMEA and FDA highlighted that the workshop provides a unique opportunity in sharing best regulatory practices and regulatory expertise AND that they would not intend to take a formal position on the proposals made. However the following categorisation discussed with FDA partners do provide an orientation for the next step of the project:

Work already done:

• Adoption of a common application form for sponsors seeking orphan designation of medicines in the EU and U.S. This common application format will now allow sponsors to apply to both jurisdictions at the same time with one application. The common application form contains a section for common information required by both the EMEA and the FDA. It also has sections for requirements unique to each agency. The EMEA and the FDA will still conduct independent reviews of such submissions to assure the data submitted meet the legal and scientific requirements of their respective jurisdictions.

Work in progress (to be intensified):

• The existing implementation plan for the EU – U.S. confidentiality arrangements includes exchanging information on Good Clinical Practice and Good Manufacturing Practice inspections which can support a more risk-based approach to selecting inspection sites with obvious benefits for resource use and health protection.

• The EU guideline on dedicated production facilities is being reviewed

• ICH guideline on "Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions" recently agreed on

• ICH proposing the development of an international standard, through a consortia of HL7, CEN and ISO, for pharmacovigilance case reports

• Under the existing EU – U.S. confidentiality arrangements: 1. Individual risks management plans and post-authorisation study commitments are being discussed 2. Certain scientific guidelines under development are debated up front 3. Information on paediatric product development plans is exchanged 4. Parallel scientific advice under the existing pilot 5. Staff exchanges and training occur

• The harmonisation of clinical trial annual safety reports is a current work item at ICH

• Collaboration is underway on the Critical Path and Innovative Medicines Initiatives.

• Harmonisation of the core structure of marketing authorisation application dossiers through the Common Technical Document and its electronic form the eCTD represent key successes of ICH with the need to continue to concentrate on regional implementation of these successes.

Proposals for careful consideration by EC/EMEA/FDA:

• Heightened bilateral cooperation on EU and U.S. located inspections.
  Formalisation of information exchange and coordination of inspections in third countries.

• Beyond the work in progress with WHO and bilaterally, further collaboration on counterfeit medicines including exchange of counterfeit alerts and upstream regulatory dialogue on any future regulations.

• Harmonisation of pharmacovigilance electronic reporting business rules, risk management templates and data transparency practices.

• Formalisation of the format and procedure for the regulatory acceptance or qualification of biomarkers.

• Whether practical arrangements could be made to enable one bioequivalence study to support generic registration in the EU and U.S.

• Further harmonisation of the CTD Summaries and identification of all the other remaining divergences on CTD content, rather than structure.

• Templates for clinical trial applications and templates and arrangements for clinical trial adverse event reporting.

• Templates for paediatric submissions.

Visionary proposals involving possible legislative changes:

Official next steps of regulators after internal reflections of the proposals:

The next steps in the process will be careful public health, legal, practical consideration of the proposals by the EU and U.S. regulators with a view to put out, in the context of the bilateral collaboration, joint prioritized roadmaps for administrative simplification. By June 2008 a roadmap for implementation will be made public jointly by the European Commission and US FDA.

The European Commission has also published a joint EC/EMEA/FDA announcement on Transatlantic Administrative Simplification Workshop for Medicine Regulation on their website:

http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/new.htm 

For more information on the Commission/EMEA / FDA confidentiality arrangements implementation plan for medicinal products for human use (updated June 200) please click on the following link:

http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos
/docs/doc2007/2007_11/implementation_plan_final_200706.pdf

To see EuropaBio’s related press release, please click here.

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