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Websites:

Heads of Medicines Agencies–Human http://heads.medagencies.org

European product index http://heads.medagencies.org/mrindex/index.html The Mutual Recognition Facilitation Group (MRFG) reports to the Heads of Medicines Agencies– Human. The group is made up of delegates from the EU, Iceland and Norway, and meets at the EMEA to coordinate Member States’ positions on topics relating to the mutual recognition procedure (MRP). Observers from the European Commission and from accession countries also participate in the monthly meetings.

The MRFG also, on request, provides procedural and regulatory advice and develops general guidance papers, which it publishes on the MRFG website.

The MRFG met 11 times in 2004. Caitríona Fisher chaired the meetings during the Irish EU presidency and Truus Janse-de Hoog chaired the meetings during the Dutch EU presidency. Two informal meetings were held in 2004, in Dublin and Scheveningen. The enlargement of the European Union on 1 May 2004 and the preparation for the implementation of the new Community legislation were permanent items on the MRFG agenda.

The number of new applications for the mutual recognition procedure in 2004 increased compared to 2003. In addition, there was an increase in the number of arbitrations of new applications compared to previous years. Statistical information on applications under the mutual recognition procedure is provided by the EMEA and presented in the monthly MRFG press releases.

Mutual recognition procedure Total submitted in 2004* Under evaluation in 2004* Ended positively in 2004* Referrals started in 2004 New applications 935 285 760 9

Type-IA variations 3 472 130 3 240 N/A

Type-IB variations 2 128 54 1 998 N/A

Type-II variations 1 402 233 1 083 0

*The numbers include multiple procedures as stated at 31 December 2004.

3 Veterinary medicines

Unit for veterinary medicines and inspections

Head of Unit Peter JONES

Head of Sector for veterinary marketing authorisation procedures Jill ASHLEY-SMITH Deputy Head of Sector for veterinary marketing authorisation

procedures Melanie LEIVERS

Head of Sector for safety of veterinary medicines Kornelia GREIN

Head of Sector for inspections Emer COOKE

The annual report for inspection activities is given in Chapter 4.

See Annex 3 for members of the committee, working parties and ad hoc groups.

Medicines for veterinary use – Highlights in 2004

• The CVMP adopted its ‘Position paper regarding availability of products for minor uses and minor species’ (EMEA/CVMP/477/03/Final) detailing the strategy to be taken in advancing the greater availability of medicines in the veterinary sector. Many of the recommendations are now in the process of being implemented.

• EudraVigilance in the veterinary sector for electronic reporting of adverse reactions became fully operational on 1 January 2005.

• The CVMP's preparation for enlargement of the European Union proved more than adequate, with the restructuring of the Committee in accordance with the revised pharmaceutical legislation taking place smoothly and without any difficulty. In addition, a new Scientific Advice Working Party was created, and its mandate and work objectives agreed by the CVMP.

• Initiatives to acquaint and train assessors and other regulatory staff with new environmental safety testing requirements were begun.

• The Scientific Advisory Group on Antimicrobials was created as planned, and its mandate and work objectives agreed and formalised by the CVMP.

• There was 100 % adherence to regulatory timelines for all activities relating to applications for centralised procedures and MRL applications.

• Good progress was achieved on improving the quality and consistency of scientific assessment reports, with a revision of the assessor guideline and the initiation of a scientific memory database for centralised procedures.

• A CVMP audit was completed in October 2004 and four ‘opportunities for improvement’ resulted; action plans addressing the concerns highlighted were finalised and submitted to the EMEA IQM team.

3.1 Scientific advice

Improving the availability of medicinal products is one of the core objectives of the EMEA. By providing scientific advice to companies developing new medicinal products, the EMEA helps to increase the likelihood of those products being granted a marketing authorisation, and thus helps to bring the products to market more quickly.

Five applications for scientific advice were received in 2004. One application involved collaboration with the Food and Drug Administration (FDA) on a parallel protocol assistance procedure, which was also subject to a follow-up procedure. This was the first time that such dialogue had occurred for a veterinary scientific advice procedure.

Scientific advice requests received 2002-2004 4 2 5 0 1 2 3 4 5 6 2002 2003 2004

Following an exchange of views with IFAH-Europe in 2004, the procedure and guidance for prospective applicants to request scientific advice has been considerably amended, which appears to be resulting in more applications. The Management Board also approved the provision of free scientific advice to companies developing products for minor uses and minor species.

Scientific Advice Working Party

A new working party was created in 2004, following the entry into force of Title IV of Regulation (EC) No 726/2004: the Scientific Advice Working Party, responsible for all requests for scientific advice relating to product development. The first meeting took place in September 2004. The mandate and work plan for the new group were published. The standard operating procedure (SOP) and web guidance document were revised considerably, taking into account comments received from interested parties.

3.2 Initial evaluation

The EMEA promotes public and animal health by reviewing new applications for authorisation of medicinal products in a timely and efficient manner, thus contributing to the provision of new and safe treatment options.

An initial evaluation is conducted by the EMEA to assess the quality, safety and efficacy of every new veterinary product that is subject to the Community or centralised procedure. Following this initial evaluation, the Committee for Medicinal Products for Veterinary Use (CVMP) adopts an opinion on whether the product should receive a marketing authorisation.

The CVMP adopted 10 positive opinions for veterinary medicines, including 8 vaccines. There were no negative opinions and 1 application was withdrawn prior to opinion.

The year’s most notable evaluations concerned:

• An equine vaccine for immunisation against Streptococcusequi for the condition of strangles — a most debilitating disease that affects horses, characterised by high fever, coughing and difficulty in swallowing due to swelling of the mandibular lymph nodes

• A new vaccine (the only one available) for active immunisation of dogs against Babesia canis and Babesia rossi to reduce severity of clinical signs associated with acute babesiosis and the anaemia that ensues following a heterologous challenge infection

• A new non-steroidal anti-inflammatory medicinal product (NSAID) belonging to the coxib group, which acts by selective inhibition of cyclooxygenase-2 (COX-2) medicated

protaglandin synthesis, for relief of pain and inflammation associated with osteoarthritis in dogs

• A range of vaccines for cats, containing live and inactivated components in various valency combinations, allowing veterinarians to adapt the vaccination programme to the needs of individual cats, for active immunisation of:

o Feline viral rhinotracheitis o Calcivirus infection

o Chlamydophilia felis infection o Feline panleucopenia

o Feline leukaemia

These vaccines contain no adjuvant and should result in less injection-site reactions in vaccinated cats

The CVMP took an average of 210 days for assessment of those new applications which received a Commission decision in 2004.

Average number of days for centralised procedures 2002-2004 210 205 210 30 46 46 71 72 56 252 268 123 0 50 100 150 200 250 300 350 2002 2003 2004 Days

Assessment phase EMEA post-opinion phase

Decision process Company clock stop

Transparency

Summaries of opinion for initial centralised applications are published at the time of adoption by the CVMP. European Public Assessment Reports are published as soon as possible after receipt of the respective Commission Decision in line with the procedure for human medicines.

Level of applications

Companies submitted 8 new applications for veterinary medicines in 2004, of which 4 were for immunologicals and 4 were for pharmaceuticals, including 1 generic. Five of the applications were for companion animals and 3 for food-producing animals, namely horses.

New centralised applications 2002-2004 3 10 8 0 2 4 6 8 10 12 2002 2003 2004

There was a shortfall of 3 applications from the 11 forecast for the year. It remains challenging to accurately predict the number of applications to be received, despite forecasts supplied by Industry, as there is, unfortunately, little intelligence available in the veterinary sector regarding new products in the development pipeline.

Greater level of satisfaction with the quality of dossiers

CVMP rapporteurs, co-rapporteurs and EMEA project managers reported (in the joint EMEA/IFAH- Europe survey on the centralised procedure) a much greater level of satisfaction with the quality of dossiers submitted than was reported in the previous survey, in which the outcome had already been regarded as very positive. This indicates that there were fewer premature applications. Part 4 of the dossier, regarding efficacy, has been identified as the area where quality of the dossier could be further improved; it is the part of the dossier which results in most questions to the applicant at day 120 of the procedure. In some cases where the applicant has been unable to address these questions and the dossier was heading for a negative opinion, this has led to the withdrawal of the application.