NEWS: New Pharmacoviglance Legislation – PrimeVigilances Perspective

These changes date back to 2003 when the European Commission decided to undertake an assessment of the pharmacovigilance system.Independent review and public consultation followed, as well as further work at the Commission, the European Medicines Agency (EMA) and EU Member States, resulting in the publication of Regulation (EC) 1235/2010 and Directive 2010/84/EC on 31 December 2010.

  • The purpose of this new legislation seems to be as follows:
  • Strengthen the public health system through better pharmacovigilance
  • Seeks to improve efficiency and quality
  • Employ better decision-making processes
  • Reduce duplication
  • Make better use of IT through the use of centralised systems and standards.

The European Commission, working with the EMA and EU Member States, has been developing Implementing Measures to provide essential technical details on what must be done by the national competent authorities (NCAs), marketing authorisation holders (MAHs) and the EMA on the introduction of the new legislation.
The current round of Implementing Measures cover the following key areas in the pharmacovigilance process:

  • Pharmacovigilance System Master File (PSMF)
  • Quality Management System
  • Use of terminologies
  • Adverse drug reaction (ADR) reporting and individual case safety report (ICSR) standards
  • Format and content of periodic safety update reports (PSURs)
  • Format and content of risk management plans (RMPs)
  • Format and content of post authorisation studies
  • Signal management responsibilities.

Sitting beneath the Regulation, Directive and Implementing Measures will be a set of Good Vigilance Practice (GVP) modules. The GVP modules will replace Volume 9A and will set out detailed, practical guidance on how MAHs and Member States should meet the requirements. GVP will be released for consultation in two phases, and the first phase was released in mid-February 2012.
The draft modules that were released in phase one are:

  • MODULE I Pharmacovigilance Systems and their Quality Systems
  • MODULE II Pharmacovigilance System Master File
  • MODULE V Risk Management Systems
  • MODULE VI Management and Reporting of Adverse Reactions
  • MODULE VII Periodic Safety Update Report
  • MODULE VIII Post-Authorisation Safety Studies
  • MODULE IX Signal Management.

Modules III and IV cover pharmacovigilance inspections and audits respectively. It is planned for these to be issued in the second wave along with modules for:

  • Additional Monitoring
  • Public Participation in Pharmacovigilance
  • Continuous Pharmacovigilance
  • Ongoing Benefit–Risk Evaluation
  • Regulatory Action
  • Planning of Public Communication
  • Incident Management
  • Referral Procedures Safety Reasons
  • Safety Communications
  • Educational Materials, and Measurement for Risk Minimisation.

PrimeVigilance  is working with leading pharmacovigilance opinion leaders to perform an in depth impact analysis on the legislative changes.
We are ideally positioned to assist your company and support you through this transitional period.
Please contact our business development team at for further information.

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