Global Pharmacovigilance

In Regulated markets, medicinal products are subject to strict testing and evaluation of their quality, efficacy and safety before being granted marketing authorisation. Once placed on the market, they continued to be monitored so as to assure that any aspect that could impact the safety profile of a medicine is detected and evaluated and that the necessary measures are taken. This monitoring is called Pharmacovigilance.

Definition of Pharmacovigilance

Pharmacovigilance (PV or PhV) can be defined as the process and science of monitoring the safety of medicines and taking action to reduce risks and increase the benefits of medicines. It is a key public health function.

EU Pharmacovigilance Legislation

EU PV legislation underwent a major overhaul which led to the adoption by the European Parliament and the European Council of new PV legislation in 2010 (Regulation (EU) No 1235/2010 and Directive 2010/84/UE), implemented in July 2012.

The legislation is supported by other Regulation about the performance of PV activities, which stipulates operational details of certain aspects of PV to be respected by entities involved in the system, and also by a series of modules on Good Pharmacovigilance Practices (GVP).

Following the implementation of this new legislation, we can safely say that the current PV system in the EU is one of the most advanced and comprehensive systems in the world and represents a robust and transparent instrument to ensure a high level of public health protection throughout the EU.

This new system, managed by the European Medicines Agency (EMA), improves patient safety and public health through better prevention, detection and assessment of adverse reactions to medicines. It also allows patients to report adverse drug reactions directly to the Competent Authorities (CAs). Additionally, reporting of adverse reactions is broadened to cover, for example, medication errors and overdose.

Main Pillars of the new legislation

  • Proactive and proportionate risk management
  • Higher quality safety data
  • Improved patient safety (thanks to modules on GVP)
  • Stronger links between safety assessments and regulatory action
  • Improved transparency, communication and patient participation (EMA has made public its database of suspected adverse drug reactions in the EU, www.adrreports.eu)
  • Clear tasks and responsibilities for all parties (Marketing Authorisation Holders, CAs, EMA)
  • Improved EU decision-making procedures
  • Establishment of a new scientific committee at the EMA: Pharmacovigilance Risk Assessment Committee (PRAC)

MAH Responsibilities

Some of the basic responsabilities of the MAH are conduct regular audits, appoint a QPPV resident in EU, administer the PV system…

Changes Introduced

  • Adverse Drug Reactions (ADR)
  • Description of PV system
  • Individual Case Safety Reports (ICSRs)
  • Periodic Safety Update Reports (PSUR)
  • Risk Management Plan (RMP)
  • Signal-detection

Business Cases

  • Case Study detail

    Local Pharmacovigilance Management

    Global Pharma Company, United States
  • Case Study detail

    Full outsourced EU Pharmacovigilance system

    Leading Generic company, North America

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