Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 108

What Is Not in the Scope of EMA?

Оглавление

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).

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

Подняться наверх