Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 112

The EMA website (http://www.ema.europa.eu/ema/) contains much useful information: Regulations, Directives, Practices, Q&A Documents, PRAC meetings, presentations, position statements, videos and Standard Operating Procedures (SOPs). These are useful to read as there are many of them, and they cover many areas of PV. They give a flavor of how the EMA handles PV on an operational level.

There is a section on European Public Assessment Reports (EPARs), which contain summaries of product-specific information (by brand and generic/INN name) on the CHMP opinions in granting Marketing Authorizations. There is often interesting safety information in each document, including the SmPC and labeling as well as the scientific reviews. See http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&mid=WC0b01ac058001d125.

There is a very useful section on inspections for GCP, GLP, GMP, and pharmacovigilance. The PV section contains information on relevant documents, scope and mission, Inspectors Working Group, and specific procedures and guidances governing inspections. The EU Risk Management Strategies site is http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000683.jsp&mid=WC0b01ac058067a113 .

There is an up-to-date page of links to the HAs of the EU and elsewhere, as well as other regulatory agencies and scientific organizations (http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/general/general_content_000155.jsp&mid=WC0b01ac0580036d63). The monthly reports of the PRAC are available at http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000537.jsp&mid=WC0b01ac058058cb18.

As the EMA was originally aimed primarily at industry and regulators, there is less consumer information compared to the FDA website or other national websites within the EU. Nevertheless, more information has been added to the website aimed at patients and the general public.

The websites of member states vary in completeness and utility even if they are now required to maintain clear communication and full transparency. They are in the native language of each country, though many have some sections in English (not always the PV section). The website of the French HA, the Agence Nationale de Sécurité du Médicament (ANSM), is useful but is in French (http://ansm.sante.fr/). The Dutch Agency’s website (https://www.igj.nl/) has a section on PV in English, as does the German Agency (https://www.bfarm.de/DE/Home/home_node.html). However, many of the key documents are in the national languages and are not translated into English.