New EU legislation aims to promote and protect public health by strengthening the Europe-wide system for monitoring the safety and benefit-risk balance of medicines. In addition to improving patient safety, this legislation also serves to supply health information to patients. Most of the legislation applies from July 2012. The new changes in regulation (Regulation (EC) No 1235/2010 and Directive 2010/84/EC) present a huge change to the industry, which will need to adapt their processes and systems within short timeframes.

The new legislation enhances the EU System of PV for medicinal products for human use by means of:

  • Establishment of a new scientific committee: The Pharmacovigilance Risk Assessment Committee (PRAC), which replaces the Pharmacovigilance Working Party. This committee is responsible for the provision of pharmacovigilance assessments and recommendations on the safety of medicines at EU level. The PRAC is composed by members of the competent authorities of the member states who are experts in medicine safety including detection, assessment, minimisation and communication of risk, and in the design of post-authorisation safety studies and pharmacovigilance audits, and independent scientific experts or representatives of healthcare professionals and patients.
  • Establishment of the Pharmacovigilance Master File: The PMF is a document that replaces the current Detailed Description of Pharmacovigilance Systems (DDPS). This obligatory document describes the company’s PV system and serves as a tool for the QPPV to maintain the oversight of the Pharmacovigilance System and compliance within the company. The Master File must be made available to the competent authority upon request upon 7 days. Serious adverse reactions occurring within in EU and non-EU are to be reported within 15 days of awareness. Non-serious reactions also occurring in Non-Interventional-Studies (NIS) are to be reported within 90 days of awareness to the EMA.
  • Changes In Periodic Safety Update Report (PSUR): The EMA has published in Feb 2012 a module VII of the guideline of good pharmacovigilance practices on PSURs: Changes include that PSURs are to a certain extent no more obligatory for generic products than for well-established products. PSURs are to be submitted electronically and only to the EMA.
  • Extended EudraVigilance Medicinal Product Dictionary (XEVMPD): By 2 July 2012 at the latest, marketing authorisation holders shall, electronically submit to the Agency information on all medicinal products for human use authorised or registered in the EU. A new format (XEVMPD) for electronic submission of this information has been implemented and published by the EMA in July and September 2011. The tool of the Agency to enter these data will become available in April 2012. Health care professionals and patients will be able to access data contained in the XEVMPD database later on.
  • Establishment of a pharmacovigilance web portal: For the purpose of enhancing the safety of medicines and to achieve more transparency and better communication in issues related to medicinal products, the EMA will establish a pharmacovigilance web portal.
  • Additional Monitoring: Some medicinal products for human use are authorised subject to additional monitoring, like new active substances and biological medicinal products including biosimilars, or products subject to conduct PASS or to conditions or restrictions with regard to its safety and effective use. The Agency should keep an updated list of such medicinal products, which also should be publicly available.
  • Conditioned Authorisation: Competent authorities might issue marketing authorisation under the condition, or subject to further specification of safety measures in the risk management system, the conduction of PASS, the fulfilment of stricter obligations on recording or reporting of ADRs, the conduction of PAES studies. The EMA has already published a module VIII of the guideline of good pharmacovigilance practices on postauthorisation safety studies:

— Andrea Schiefer, Vice President of European Clinical Operations and Executive Director of Pharmacovigilance, Clinipace Worldwide and Sandra Landa, EU Pharmacovigilance Manager, Clinipace Worldwide