EMA Pharmacovigilance Legislation to Take Effect; New Q&A Document Offers Practical Guidance to Industry

Jun 06, 2012

In July 2012, new pharmacovigilance legislation will come into effect across the EU as a result of changes adopted in 2010, specifically EU Regulation No. 1235 and Directive 84. Information that marketing authorization holders provide to EMA and other regulatory authorities about their pharmacovigilance systems will change according to advice from the Medicines and Healthcare Regulatory Agency (MHRA) as follows:

  • Only a summary of information pertaining to the EU qualified person for pharmacovigilance and the location of a pharmacovigilance system master file will need to be noted in marketing authorizations.
  • Full descriptive information about the pharmacovigilance system will have to be contained in a pharmacovigilance system master file, which should be made available to the National Competent Authorities upon request.
  • Detailed requirements for the pharmacovigilance system master file include its availability, structure, content and maintenance.
  • The pharmacovigilance system master file will need to encompass the pharmacovigilance system. The system, therefore, may relate to one or more products, and changes to its content will not be automatically notifiable to the Competent Authorities.

The full guideline can be accessed here.

The submission information noted above is different from the current Detailed Description of the Pharmacovigilance system (DDPS), which will be phased out over the period from July 2012–2015.

On May 23, 2012, EMA published a set of Question and Answers covering a number of topics related to the legislation. The document explains some practical considerations that the industry will need to consider. Specifically, the Q&A document provides guidelines on:

  • Good pharmacovigilance practice guidelines
  • Pharmacovigilance system master files and summary of the pharmacovigilance system
  • Risk management plans
  • Postauthorization safety studies
  • Periodic safety update reports and EU reference date list
  • Literature monitoring
  • Product information and the black symbol
  • Adverse drug-reaction reporting and signal management
  • Renewals.
  • EMA plans to update the Q&A document on a regular basis. Questions can be sent to qanda-pv-legislation@ema.europa.eu.