Pharmacovigilance in the European Union

The science of pharmacovigilance is reliant on the collection and accurate processing of data from all over the world. The data is evaluated to produce meaningful drug safety information, from which appropriate actions can be taken as required. This page briefly introduces some major regulatory bodies where the data is held within the European Union (EU).

The Role Of The European Medicines Agency (EMA)

The EMA is the regulatory body with responsibility for all EU member states. It coordinates a network of some 4,000 pharmacovigilance experts from the national regulatory authorities of 31 countries from the EU and European Economic Area (EEA). Its activities include publishing the guidelines which inform Marketing Authorisation Holders (MAHs) and EU clinical trial sponsors on safety, efficacy and quality for both human and veterinary products. The Committee for Medicinal Human Products (CHMP) has been established as the body through which all pharmacovigilance activities for drugs intended for people takes place on behalf of the EMA.

When pharmaceutical companies aim to place any new drug onto an EU market, they must apply for a Marketing Authorisation (MA). There are 4 routes via which this can be done: the National, Centralised, Decentralised, and Mutual Recognition procedures. The application for the centralised route must be made directly to the EMA, and evaluation of the quality, efficacy, and safety are carried out by an appointed Rapporteur and co-Rapporteur assessor from two of the EU Member State regulatory authorities. Their assessments are then considered by the CHMP which makes a recommendation to the European Commission. Should the application be successful, the European Commission grants a Marketing Authorisation, and the product may then be sold in any or all of the 27 EU member states. Many MA applications now take this route, in particular for any medicinal product derived from biotechnology as well as medicines intended for the treatment of:

• Cancer
• Diabetes
• HIV/AIDS
• Neurodegenerative diseases
• Rare diseases

As distinct from the Centralised procedure, individual EU countries may issue National marketing authorizations for medicinal products based on a local assessment of quality, efficacy and safety. Sometimes, a company will use one such National MA as the basis for a Mutual Recognition procedure: that country acts as the Reference Member State and its assessment is evaluated by other EU countries – the Concerned Member States – so that the product can then be marketed in the countries that accept the assessment. The Decentralised procedure is similar – mostly used for generic medicines – it involves a synchronized submission followed by assessment by several EU countries.

Data About Drugs For Rare Diseases

Medicinal products intended for the treatment of rare diseases are termed ‘Orphan Drugs. The Committee for Orphan Medicinal Products (COMP) is responsible for recommending orphan designation of medicines for rare diseases.

Data About Herbal Medicines

The Committee on Herbal Medicinal Products (HMPC) reviews applications for marketing of herbal medicinal products intended for sale within the EU.

EU Safety databases

From November 2017, all marketed product serious and non-serious Individual Case Safety Reports (ICSRs) occurring within the EEA have been reported directly to EudraVigilance by MAHs and other stakeholders under simplified centralized reporting.

Regulatory authorities or, in some instances such as the Netherlands, independent national pharmacovigilance centers, hold databases on post-marketing spontaneous and clinical trial adverse reactions.

The EMA manages the Eudravigilance database which is a repository for adverse reaction data from post-marketing spontaneous reports and of serious adverse reactions from clinical trials from across the EU.

The Flow Of Information

Reports of Adverse Reactions may be generated by individual doctors, nurses, other healthcare professionals, pharmacists or patients themselves or their friends, relatives, or others. They may be submitted to national regulatory authorities, where appropriate, the independent national pharmacovigilance centers, to regional centers in various countries, or to the pharmaceutical company.

Pharmaceutical companies must operate a suitable safety database to allow for timely and accurate reporting in the correct format to the national authorities and EMA.