Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition). William Gregory
by the Member States, and usually reside in the Member States but may attend periodic meetings at the EMA or elsewhere.
The EMA is headed by an executive director with seven reporting divisions. The “Inspections, Human Medicines Pharmacovigilance & Committees Division” handles drug safety. The other Divisions are “Human Medicines Research & Development Support”, “Human Medicines Evaluation”, “Veterinary Medicines”, “Administration and Corporate Management”, “Information Management” and “Stakeholders & Communication”. See the organization chart below or on the EMA web-site. As with any organization, changes occur over time (http://www.ema.europa.eu/ema/).
Seven scientific committees, with members from all 31 EU/EEA states, handle the main scientific work of the Agency:
1.Committee for Medicinal Products for Human Use (CHMP);
2.Pharmacovigilance Risk Assessment Committee (PRAC);
3.Committee for Medicinal Products for Veterinary Use (CVMP);
4.Committee for Orphan Medicinal Products (COMP);
5.Committee on Herbal Medicinal Products (HMPC);
6.Paediatric Committee (PDCO);
7.Committee for Advanced Therapies (CAT).
Note 1: Within these committees, the role of each EU country representative is not to defend a local recommendation but to ensure that the EU decision is actually applicable to and valid for all EU countries.
Note 2: The CMD(h) covers a variety of issues related to new applications, variations, renewals and pharmacovigilance activities for nationally-authorized medicines. It is not strictly-speaking an EMA Committee even if CMD(h) meetings are held at the EMA.
The highest-level committee handling human medicines is the Committee for Medicinal Products for Human Use (CHMP). It is responsible for the following:
Risk Management
The EU has developed a comprehensive risk management strategy for all products in the EEA. This is a strategy that covers the entire life cycle of a product, and a risk analysis is required for every product upon approval (or during its marketing). A specific committee (PRAC), replacing the former PV Working Party, was set up in 2012 (see below). The goal is to have a set of pharmacovigilance activities and potential non-routine interventions designed to identify, characterize, prevent, and minimize risks relating to medicinal products, including the assessment of the effectiveness of these interventions.
EudraVigilance — The EU Safety Database
In 2001, an EU-wide central database, called the Eudra-Vigilance System, was created (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000679.jsp). This database serves as a repository and “clearinghouse” to ensure that all appropriate cases are available to the appropriate member states. It is used to capture SAEs as Individual Case Safety Reports (ICSRs) both pre- and post-authorization as well as spontaneous non-serious AEs. It has been designed to manage and analyze information on suspected adverse reactions to medicines which have been authorized or are being studied in clinical trials in the European Economic Area (EEA).
The EMA operates the system. This allows for a single European database accessible to the member states’ HAs. Individual cases (ICSRs) must now be reported electronically from both public and private PV organizations (using the gateway or the web reporting application).
The pharmaceutical industry can only access detailed, proprietary data for medicines for which they hold a marketing authorization. This restriction is in place to remain in compliance with EU personal data protection and privacy legislation. They can, of course, access the high level summary information available to the general public on all medications in EudraVigilance (http://www.adrreports.eu/en/index.html). Simple queries can deliver online summary tables or figures depending on the selected criteria.
The European pharmacovigilance issues tracking tool (EPITT) is a database developed by EMA for the communication of pharmacovigilance and risk-management issues between the Agency and Member States. It provides access to documents related to the safety of products/substances authorized in the EEA. The EPITT provides the functionalities for national regulatory authorities in the EEA and EMA to track signals at EU level. It is not available to the public or the pharmaceutical industry.
Other computerized systems have been developed by the EMA:
In addition to the EMA, each European country has its own national health authority (HA) or authorities that handle drug safety. They are often called “competent authorities (CA)” in EU regulatory jargon. The EU is still evolving and the Lisbon Treaty (2005) and other subsequent treaties have altered some of the basic structures and functions of the EU governing bodies. The EU remains still a work in progress. The interplay between the central authority (primarily in Brussels but with various agencies scattered throughout the EU, such as the EMA in London/Amsterdam and the European Central Bank in Frankfurt, Germany) and the individual countries is dynamic and often changing.