Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition). William Gregory

EMA does not have jurisdiction over food. The European Food Safety Authority in Parma, Italy handles those matters.

      As noted, for drug safety, some functions are primarily centralized in the EMA and some remain in each member state. Some national authorities are very large and powerful and exert strong influence over smaller member states. This division and, in many cases, duplication of labor, as well as the multitude of languages involved in the EU, produce a challenge for safety reporting both for the pharmaceutical industry and for the member states themselves. Most of the work in drug safety is done at the international level in English, but, obviously, at the local level the national languages are still used. The comparison with other countries, particularly the US, where the drug safety function is clearly centralized, is striking. The closest analogy would be if each of the 50 states in the US had its own mini-FDA and used languages other than English. With the UK leaving the EU, there remain only two countries that have English as a native, national language: Malta and Eire (Ireland). There has been some talk of now using more French and German. “A voir”. “Bleibt abzuwarten”. We shall see.

      In terms of pharmacovigilance, the EMA has largely harmonized along the lines of ICH. They have codified the pre-marketing requirements in a document known as Regulation (EU) No. 536/2014 of the European Parliament and of the Council of 16 April 2014 and the post-marketing requirements in Regulation (EU) Nos. 1235/2010 and 1027/2012. Each is discussed in detail below. Nonetheless, there are still differences, particularly for clinical trial pharmacovigilance, from country to country.

      With the regulation updated in 2010, a major effort has been made for an accurate communication and transparency. Numerous tools and publications have been set up to comply with this commitment including the EMA web portal, the publishing of committee meetings’ agendas and minutes, ad hoc newsletters such as “What’s new in Pharmacovigilance QPPV Updates”, public hearings, etc.).

      For more information on the EMA, see the following websites:

      EMA website (http://www.ema.europa.eu/ema/);

      EMA PV System Manual (http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/07/WC500170226.pdf);

      Eudravigilance (https://eudravigilance.ema.europa.eu/);

      PV Q&A web page (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000135.jsp&mid=WC0b01ac058066e97a -).

What Is Not in the Scope of EMA?

      EMA does not perform the following:

      Evaluate the initial marketing authorization application of all medicines in the EU (as many drugs have been approved before the creation of the EMA in 1995, the vast majority of medicines registered in the EU are authorized at a national level). However, the centralized process must be used for new products, e.g., biosimilars, gene products, etc.

      Evaluate applications for the authorization of clinical trials. The authorization of clinical trials occurs at Member State level, although the Agency plays a key role in ensuring that the standards of good clinical practice are applied. The EMA also manages the database of clinical trials carried out in the EU.

      Evaluate medical devices, food supplements and cosmetics. These are evaluated at national level.

      Carry out research or develop medicines.

      Make decisions on the price or availability of medicines. This is done at the national level.

      Control medicines advertising. Also done at the national level.

      Control or have information on pharmaceutical patents.

      Develop treatment guidelines.

      Provide medical advice to any stakeholder group.

      Develop laws concerning medicines. The European Commission develops EU legislation concerning medicines and the European Parliament together with the Council of the European Union adopt the legislation. The European Commission also develops EU policies in the field of human or veterinary medicines and public health.

      Issue marketing authorizations. The legal decision to grant, suspend or revoke a marketing authorization for any medicine falls under the remit of the European Commission for centrally authorized products, and the national competent authorities of the EU Member States for nationally authorized products.

      For more information, see (http://www.ema.europa.eu/docs/en_GB/document_library/Other/2016/08/WC500211862.pdf).

The Pharmacovigilance Risk Assessment Committee

      The Pharmacovigilance Risk Assessment Committee (PRAC) has experts from each member state; it provides its advice and recommendations to the EU network, and for many procedures these recommendations are considered by the CHMP before they become legally binding. They meet for 3–4 days each month (except August).

      The PRAC was formally established in July 2012, replacing the former PV Working Party (PhVWP); it is responsible for assessing all aspects of risk management of human medicines, including the following:

      The detection, assessment, minimization and communication of the risk of adverse reactions, while taking the therapeutic effect of the medicine into account to evaluate the benefit/risk balance;

      The design and evaluation of post-authorization safety studies (PASS);

      Pharmacovigilance audits/inspections.

      The PRAC also advises the EMA on the development of guidelines, standards, and provides advice on operational aspects of the EU pharmacovigilance system.

      The PRAC provides recommendations on questions involving pharmacovigilance and risk management systems, including the monitoring of their effectiveness, to the following:

      CHMP for centrally authorized medicines and referral procedures;