EGA Press Release

Wednesday, 10 November 2010

EGA PAYS TRIBUTE TO EMA EXECUTIVE DIRECTOR THOMAS LÖNNGREN
DURING 3rd EMA-EGA INFO DAY

The European Medicines Agency has today hosted the third EMA-EGA Info Day. There has been growing interest in the European generic medicines industry’s use of the Centralised Procedure in order to obtain a Marketing Authorisation that is valid in all the EEA markets. The Info Day has provided a unique opportunity to share companies’ experiences with the Centralised Procedure for generic and biosimilar medicines applications from the perspectives of both the Agency and the Industry.

In his opening presentation, Greg Perry, Director General of the EGA, congratulated Executive Director Thomas Lönngren for the Agency’s outstanding achievements during his 10 years’ leadership, and his steering of the Agency to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public health. “Our industry could also benefit from an efficient implementation by the Agency of the 2004 EU pharmaceutical legislation, which set out a legal framework for biosimilar and generic registrations via the centralised route,” Mr Perry added. The Agency, together with Experts from National Competent Authorities, pioneered the scientific framework for biosimilar medicines and continues to lead worldwide in developing scientific guidelines, the next one being for biosimilar monoclonal antibodies.

Mr. Perry further emphasised the importance of the generic medicines industry in European healthcare, as it provides almost half of the medicines consumed by patients in Europe, which, however, account for only 18% of the total cost. Added focus on an effective regulatory environment will only serve to increase these savings. “Our industry needs an efficient and predictable regulatory system including the Centralised Procedure (CP) and the Decentralised Procedure (DCP), as 83% of all DCP and 68% of all Mutual Recognition Procedure (MRP) applications are related to generic medicines, as well as almost 50% of applications in 2009 in the CP,” Greg Perry continued. Having access to the Centralised Procedure was considered to be a milestone in the history of registering generic medicines, but this route is now hampered by the European Commission’s new handling of duplicate marketing authorisations, which are not allowed for marketing entities belonging to the same group of companies. “This constitutes a barrier to trade and access to the single market, creates a distortion between the CP and DCP and will slow down the dynamic of market penetration of generic and biosimilar medicines. We need to find a solution urgently”, said Michael Banks, Vice President Regulatory Affairs Europe, TEVA Pharmaceuticals and Chair of the EMA-EGA Working Group and EGA Regulatory & Scientific Affairs Committee.

Hoping for a rapid adoption of the Falsified Medicines Directive, the EGA has also taken the opportunity to pro-actively share its recommendations for effective implementation of the new legislation. Suzette Kox, EGA Senior Director Scientific Affairs, concluded: “Success will be on the horizon if we can achieve continuous exchange and consultation between stakeholders, prioritise regulatory dialogue with key API exporting countries and secure the budget for the Eudra Databases, cornerstones of a dynamic, yet smooth, information system”.

The EGA also shared its Vision 2015, following the official launch of the document at the Heads of Medicines Agencies meeting in Antwerp on 26 October 2010. The EGA believes that the regulatory environment needs to be optimised in order to fully exploit the advantages offered by generic and biosimilar medicines for the sake of healthcare sustainability.

---

For further information contact Suzette Kox
E-mail: