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bridges vol. 11, September 2006 / Institutions & Organizations
by Irene Eckart

canary_wharf_from_observatoLondon is not the typical location for an EU body. First, because it is not Brussels; and second because Britain often likes to distinguish itself from "Europe," as many British refer to continental Europe. And yet the European Medicines Agency, the pharmaceutical regulatory body of the EU, has its headquarters at 7 Westferry Circus in London's Docklands, an area formerly used as a harbor, and today home to major banks, auditing firms, and media companies. Some say that this location was a consolation prize to the British for not being allowed to host the European Central Bank, an endeavor the UK pursued despite its intention never to adopt the Euro (€). Looking at the EMEA's efforts regarding transatlantic cooperation, however, the location might not be a mere happenstance, or if so, it was a lucky one.

emealogowhitebackground What is the EMEA?
The European regulatory system for medicines is complex for the simple reason that the Member States regulate medicine together. This means that there are national agencies in addition to one central regulatory body, the European Medicines Agency, created in 1995. The recent expansion of the European Union to a membership of 25, as well as plans for future enlargement, is a challenge to every aspect of integration, and pharmaceutical regulation is no exception. Consequently, the EMEA's main responsibility and mission is to coordinate the scientific resources of the 25 EU Member States, with a view to providing European citizens with high quality, safe, and effective medicines for humans and animals and, at the same time, to advance towards a single market for medicines.

{access view=guest}Access to the full article is free, but requires you to register. Registration is simple and quick - all we need is your name and a valid e-mail address. We appreciate your interest in bridges.{/access} {access view=!guest} In 2005, ten years after its inauguration, the EMEA's mandate was significantly broadened as a result of a revision of the Agency's founding legislation: Regulation (EC) No 726/2004 (replacing Regulation (EEC) No 2309/93 ) which changed the Agency's name from European Agency for the Evaluation of Medicinal Products to European Medicines Agency - a designation that is more easily memorable and finally reflects the Agency's acronym, EMEA - and entailed organizational changes and an expansion of EMEA's responsibilities.

"In line with its ever-extending responsibilities, the Agency has grown considerably over the years," says Monika Benstetter from the EMEA's press office. And the numbers speak for themselves: The EMEA started off as a relatively small Agency with 67 staff and a total budget of just over €14 million. In 2006 more than 400 people are working for the Agency with a budget of more than €123 million.

Staff development


As to the EMEA's organizational structure, the Agency is headed by its executive director, Thomas LΓΆnngren, and has a Management Board responsible, in particular, for budgetary matters. The secretariat coordinates the pre- and post-authorization evaluations and inspections. However, the EMEA is carrying out its work by operating within a network of more than 40 nationally competent authorities, which have put the expertise of some 4000 scientists at the disposal of the EMEA, according to Benstetter.


The European system for authorizing medicinal products & pharmacovigilance
Upon the Agency's creation, in an effort to promote the European pharmaceutical industry's competitiveness and the sharing of drug safety and efficacy data, the biggest challenge was to bring to life a new European regulatory system. Implemented by the EMEA in 1995, the system was amended in 2004 by the aforementioned Regulation (EC) No 726/2004 . It comprises a new marketing authorization procedure, the centralized procedure in which new medicines are approved for marketing throughout the EU on the basis of a single central decision, and a mutual recognition procedure. (Previously, medical products were reviewed and approved for marketing at the national level, which meant that companies had to undergo the approval process in each country where the product was to be launched.)

The EMEA has a role in both, but is primarily involved in the centralized procedure, where companies submit a single marketing authorization application to the EMEA which conducts a thorough evaluation, drawing from its extensive network of scientific resources across Europe. If the new medicine is proven to fulfill the requirements for quality, safety, and efficacy, the responsible committee (human - CHMP - or veterinary - CVMP ) adopts a positive opinion, which is transmitted to the European Commission for the marketing authorization to be granted. Practically, the committees' opinions constitute the final decision (none has ever been overturned by the Commission); legally, however, the Commission is prohibited from delegating decision-making to bodies such as the EMEA.

Not all medicinal products, however, have to undergo the centralized procedure. "It is obligatory for the approval of products derived from biotechnology, as well as for all new substances intended for the treatment of HIV/AIDS, cancer, neurodegenerative disorders, diabetes, and orphan designated [i.e., medicines for rare diseases] products," Benstetter informs.

All other innovative pharmaceutical products can be approved through the mutual recognition procedure. Thereby a medicinal product that has been proven to comply with the requirements for quality, safety, and efficacy by the competent authority of one Member State is mutually recognized throughout the EU. Benstetter notes that, in case of a dispute between Member States, the EMEA can be called upon to provide a scientific opinion on the issue raised, which will be the basis for the European Commission's final decision on the matter.

The EMEA's role in the lifecycle of a new medicinal product does not end at the evaluation stage. Once authorized for the EU market, the product is constantly monitored to ensure that the benefit/risk balance remains favorable for the human or animal population it was designed to help. This monitoring process, known as pharmacovigilance, is a key aspect of the work carried out by the Agency and its partners. As part of the follow-up on any side effects with a medicinal product, the EMEA receives so-called adverse drug reaction reports, which are entered in a Europe-wide drug safety database called EudraVigilance . Based on the assessment of the reports received, the Agency can decide to recommend the temporary suspension or complete withdrawal of a medicinal product from the market, or demand that more or better information (e.g., safety warnings) concerning the product be made available to patients and health-care professionals.

In addition to its original task of drug authorization, the EMEA has set up several initiatives under its extended mandate. Particular achievements mentioned in the 2005 Annual Report include the successful launch of an SME Office, the provision of early stage scientific advice to companies developing "breakthrough" medicines, and the introduction of new measures to accelerate the assessment of medicines that are of critical importance to public health.

Transatlantic cooperation: FDA - comparator and collaborator
Although drug regulation is a national or European responsibility, products are international and their life cycles are a global phenomenon requiring EMEA to cooperate closely with international partners. According to Monika Benstetter, the EMEA engages in several multilateral forums bringing together the regulatory authorities of Europe, Japan, and the United States, and experts from the pharmaceutical industry in the three regions, to discuss scientific and technical aspects of product authorization.

Particularly close bilateral relations are in place with the US Food and Drug Administration (FDA), the main comparator and collaborator for the EMEA. Although the EMEA and the FDA have similar responsibilities with regard to the evaluation and supervision of medicinal products, the EMEA was never intended to mirror the FDA, and the organizational structures of the two Agencies are very dissimilar. The obvious differences are the FDA's larger size and more ambitious mission (covering not only medicines but also food and medical devices) as well as the fact that the FDA stands alone, and not alongside national regulatory agencies as does the EMEA.

A more detailed look at the respective rules and procedures reveals that the European regulatory environment is different in many ways. This is not only due to different health-care delivery systems but also to different legal tools and, possibly, a more conservative attitude when it comes to the safety of medicines. Europe for example is much faster to take a product off the market. On the approvals side there are more similarities, and overall there is a need for better collaboration between the EMEA and the FDA.

This requirement was met in September 2003 with a confidentiality agreement established between the European Commission, the EMEA, and the FDA, allowing them to exchange information as part of their regulatory processes. "The types of information covered by the arrangement include legal and regulatory issues, scientific advice, orphan drug designation, inspection reports, marketing authorization procedures, and post-marketing surveillance," says Benstetter, and adds: "In addition, the European Commission has mutual recognition agreements with Australia, Canada, Japan, New Zealand, and Switzerland."

Outlook: challenges & opportunities
With the enlargement of the European Union from 15 to 25 Member States and a revision of the EU pharmaceutical legislation, the EMEA saw the biggest changes in its history in 2004 and 2005. But the Agency has planned ahead and is ambitiously looking into the future. Based on recent political, institutional, legislative, and scientific developments within the EU, the EMEA has developed a long-term strategy to guide its planning until 2010: "The European Medicines Agency Road Map to 2010: Preparing the Ground for the Future. " As a result of the Road Map's implementation to date, the quality assurance system of scientific assessments has been improved, the Agency offers better support to applicants in the development of new therapeutic approaches and technologies and, building on the National Competent Authorities' resources and expertise, the Agency has developed a European Risk Management Strategy (ERMS) for safer medicines.

The EMEA has a somewhat ambivalent mission as it is obliged to consider both the interests of patients and those of the pharmaceutical industry. Irrespective of this general polarity, another cause for concern, and a source of a potential conflict of interest, is the composition of the Agency's revenue. In addition to EU subsidies, the EMEA receives fees directly from the industry it regulates for obtaining marketing authorizations and for other services, which inevitably raises the question of independence.

The EMEA's answer is a strict code of conduct and full transparency. The particular organization of the scientific committes ensures that EMEA's scientific opinions are based on scientifically sound evidence by facilitating peer review of the scientific assessment of data submitted by the pharmaceutical industry. This is undertaken by independent teams of assessors. Members of scientific committees and the European experts are not permitted to have any direct financial or other interests in the pharmaceutical industry which could affect their impartiality; and each expert also signs a pledge of confidentiality. To communicate this to the outside world, transparency is key. Therefore the Agency makes all assessment reports available online and engages in a permanent dialogue with its stakeholders: national authorities, doctors, pharmacists, consumers, and patient groups.

A 2005 EMEA-FDA pilot project for parallel scientific advice demonstrates both the importance the EMEA has gained during its relatively short existence and its efforts towards transatlantic cooperation. "Involvement of the EMEA in a new medicine starts normally a long time before an application has been submitted. The EMEA assists pharmaceutical companies during the R&D phase by providing guidelines and scientific advice on specific questions relating to the manufacture, development or testing of the medicine," says Benstetter and explains the pilot project. Parallel advice can be requested either by companies themselves or by either of the Agencies (EMEA or FDA), thus facilitating an international dialogue from the earliest stage of the product life cycle. As a result, product development can be optimized by avoiding unnecessary replication of testing or unnecessarily divergent testing methodologies, and additional critical issues can be identified and shared simultaneously by both agencies.

Having granted some 400 centralized marketing authorizations for medicinal products for human and veterinary use to date, the EMEA, despite some initial skeptics, has proved that a centralized authorization procedure can work successfully by securing consensus among scientists from many different medical cultures. The new legislation and the Agency's numerous initiatives will enable it to do much more - to provide a boost to R&D across Europe.

Contact Information
7 Westferry Circus
Canary Wharf
London E14 4HB
United Kingdom

Tel.: (44-20) 74 18 84 00
Fax: (44-20) 74 18 84 16

This email address is being protected from spambots. You need JavaScript enabled to view it.

The author, Irene Eckart, is a member of the editorial team of bridges at the Office of Science & Technology at the Embassy of Austria in Washington, DC.

The above article was prepared based on the sources below and an interview with Monika Benstetter from the EMEA's press office.

The European Medicines Agency (EMEA)

Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency [Official Journal L 136/1 of 30.04.2004] Summary:

Directive 2001/82/EC
of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products [Official Journal L 311 of 28.11.2001]

Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use [Official Journal L 311 of 28.11.2001]