NEWS: New Pharmacoviglance Legislation – PrimeVigilances Perspective
Published 20 May 2012.
The new pharmacovigilance legislation in July of this year will be the biggest change to medicines legislation since the creation of the current European system in 1995.
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
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:
Public Participation in Pharmacovigilance
Ongoing Benefit–Risk Evaluation
Planning of Public Communication
Referral Procedures Safety Reasons
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.