EPAA Conference

5 November 2007

Georgette LALIS

Enterprise and Industry DGEuropean Commission

The international dimension ofregulatory acceptance

EPAA Conference 2006

Workshop Regulatory Acceptance, June 2007

Highlighted the importance of acceptance at a global level

Addressed a plea to the EU to maintain alternative approaches on the agenda of the regulatory dialogue with trading partners

Action currently being undertaken

Mainly in a multilateral context

On the basis of procedures that, according to sectors, are more or less formally established

Progress being verified in regulatory dialogue on a bilateral level

Chemicals

Main forum for discussion is the OECD

Principle of Mutual Acceptance

OECD guidance N° 34

OECD Test Guidelines, adopted as testing methods in EU regulation for chemicals

Pharmaceuticals

At the request of the Commission, the EMEA has conducted a review of current international (ICH) non-clinical guidelines to see whether they were up to date and whether their was scope to promote the 3Rs agenda.

Based on the Safety Working Parties scientific review, the European Commission then proposed a review of the ICH guidelines by ICH

A formal review started at the June 2006 ICH meeting

ICH Steering Committee May 2007.

Confirmed its commitment to the 3Rs agenda, with a view to the replace, reduce or refine animal testing when drafting new or revising existing guidelines.

Is committed to ensuring that groups working on ongoing and new topics document their impact on animal testing

From the EU initiated ICH review, three ICH guidelines are under revision

carcinogenicity, genotoxicity and the non-clinical studies necessary for human trials guidelines.

The European Commission is confident that the ongoing ICH work will have a positive impact for the three-Rs agenda

Cooperation with validation bodies

First contacts took place between the non-clinical safety experts working within ICH and the organisations for “Validation of Alternative Methods” in the three regions

Update on ongoing activities regarding alternative methods to animal testing and looking for ways to increase mutual understanding and collaboration

European Directorate for the Quality of Medicines & HealthCare, EDQM

Council of Europe

European Pharmacopeia

“In accordance with the European Convention …… the Ph. Eur. Commission (Council of Europe) is committed to the reduction of animal usage, wherever possible, in pharmacopoeia testing and encourages those associated with its work to seek alternative procedures. An alternative or modified method is adopted by the Commission once it has been clearly demonstrated that it offers satisfactory control for pharmacopoeial purposes”

European Directorate for the Quality of Medicines & HealthCare, EDQM

Council of Europe

Progress has been made in implementing the 3Rs

EDQM has initiated an enquiry aimed at verifying to what extent 3R methods have been transposed and are being implemented by stakeholders

Collaboration has been established between EDQM and ECVAM.

Cosmetics

First meeting European Commission, FDA, Health Canada and the Ministry of Health, Labour and Welfare, Japan, in September, 2007 in Brussels to discuss regulatory issues relating to cosmetic products.

Establishment of the ICCR, the "International Cooperation on Cosmetic Regulation" , for information exchange aiming at ensuring safety of cosmetic products through

international cooperation

Alternative methods identified as a priority

Intensive collaboration and communication in the design, execution, and peer review of validation studies should be further strengthened

ICCVAM, ECVAM, JaCVAM and Canada should address this issue and propose options to ensure a collaborative approach

They should be supported by scientific experts from the regulatory bodies

Regulatory authorities committed to implementation of 3R approaches

Need to involve regulators in validation processes

Experience suggests that if there are substantial discrepancies between U.S. and EU at the regulation stage, they are usually due to different appraisals at the peer review stage

Cooperation, also on peer review, might be strengthened by an International Council of Validation Bodies

Overall assessment