Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 105

The EMA handles human and veterinary medicinal products (but not food, unlike the FDA). Whatever the registration status, the EMA goal is to ensure harmonized safety surveillance for all EU countries.

The EMA principle is based on a central organization (~900 EMA permanent employees), supported by ~4,500 experts, who conduct the detailed, work of the Agency by sitting on scientific and medical committees, working groups, and assessment teams. These experts are made available 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:

Conducting the initial assessment of EU-wide marketing authorization applications,

Assessing modifications or extensions (“variations”) to an existing marketing authorization.

Considering the recommendations of the Agency’s PRAC regarding the safety of medicines on the market and, when necessary, recommending to the European Commission (EC) changes to a medicine’s marketing authorization, or, in extreme instances, its suspension or withdrawal from the market. The EC is the senior commission and is above the CHMP and PRAC.