Members Area | Register

Pharmacovigilance

The purpose of pharmacovigilance is to improve the safety of the public when taking medicines.

In the UK and other countries of the European Union it is a legal requirement that pharmaceutical companies marketing medicinal products, Market Authorisation Holders (MAH) have in place systems to receive, record and analyse information concerning adverse experiences to a medicinal product. This information is pharmacovigilance data. The relevant EU legislation can be found in the Regulation 726/2004 an Directive 2001/83/EC as amended.

There is also a requirement for the pharmacovigilance data to be submitted to the appropriate regulatory authority, in the UK the Medicines and Healthcare products Regulatory Authority (MHRA) or regionally to the European Medicines Agency (EMEA).

A detailed account of Good Pharmacovigilance Practice (GPvP) can be found in a book of that title produced by the MHRA and published by the Pharmaceutical Press.www.pharmpress.com

While clinical trials performed during the development of new medicines are a key step in assuring the safety of those medicines, it is also essential that ongoing surveillance during widespread use in the population is undertaken by the appropriate national drug regulatory authority.

In practice many national drug regulatory authorities have a range of systems to monitor post marketing drug safety. The national authority may also have a commitment to analyse and collate drug safety information and pass onto to international organisations, in Europe this is EUDRA and globally WHO.

Systems designed to monitor post marketing drug safety are collectively called Pharmacovigilance and include the following:

• Monitoring published papers and data.
• Reporting adverse drug reactions (ADRs) by healthcare professionals.
• Industrial processes for receiving and reporting ADRs related to their products.