EGA Press Statement

Friday, 11 March 2005

EMEA 10th ANNIVERSARY CONFERENCE
— London - 11 March 2005 —
Statement by Greg Perry, Director General EGA

In a statement delivered at the EMEA’s 10th Anniversary Conference in London today, EGA Director General Greg Perry underscored the important new relationship developing between the agency and generic medicines producers.

The EGA has a very special interest in celebrating the EMEA’s 10th Anniversary as this year also sees generic medicines companies in Europe preparing to use the EU’s Centralised Procedure (CP) for generic and bio-similar products for the first time.

To date the EGA has focused on its relationship with national medicines agencies, as the generic industry has become the principal user of the current Mutual Recognition Procedure. Whilst our industry will continue to develop its relations with national medicines agencies through the new Decentralised Procedure, the industry will also become an important new user of the Centralised Procedure (CP). Undertaking registrations with the EMEA will be a new experience for the generics sector of the industry.

To prepare the ground for an abridged Centralised Procedure, a team of EGA companies have been working together with EMEA staff over the past year. Similarly we have worked for some time with the EMEA staff in relation to the development of a regulatory pathway for Bio-similars. At this point, I would like to thank the EMEA for the constructive, open and highly professional manner in which the dialogue has operated in both these areas.

There is still work to be done in preparing the way for the generic partnership with the EMEA.

As regards the use of the Centralised Procedure for generic equivalents of originator products approved through the CP, it should be recalled that this is simply one option, and generics companies are still free to use the MRP-DCP route. It is therefore important that a competitive fee structure and a clearly defined time frame are developed for the abridged CP.

In the case of biosimilar medicinal products (“biogenerics”), creating a regulatory pathway for their approval in advance of the USA has now created an enormous competitive advantage for Europe. We believe that the combination of this pathway and the introduction of a EU Bolar provision will give us the opportunity to make Europe the global leader in biosimilar medicinal products. However, we must move quickly in relation to the development of guidelines in this area and to hold the long awaited workshop on biosimilars earlier rather than later in the year.

In conclusion, for us in the generic medicines sector, this 10th anniversary is not only an important celebration of the success of the EMEA and of the major contribution that the Agency has made to public health. It is also a pivotal year for our industry as we enter a new and important relationship with the Agency. I hope that in 10 years time the EGA will be able to report back on a decade of success in generic and bio-similar medicines applications with the EMEA.

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