EMA requests feedback on new pharmacovigilance rules
Releases concept paper exploring technical issues in depth
The European Commission has asked the European Union (EU) pharmaceutical industry for comments on its planned implementation of new EU Pharmacovigilance rules that come into force in July 2012.
It has released a concept paper exploring a range of technical issues in depth, to prepare the industry for the new EU regulation No.1235/2010 and directive 2010/84/EU.
The document provides information on how Brussels wants the pharma industry to adopt the rules, covering the following topics:
- Working with pharmacovigilance system master files;
- The minimum requirements for quality systems that assess pharmacovigilance activities;
- The use of internationally agreed terminology, formats and standards;
- Monitoring EudraVigilance data;
- Electronically transmitting suspected adverse reactions;
- Handling electronic periodic safety update reports plus risk-management plans; and
- The format of protocols, abstracts and final study reports for post-authorisation safety studies.
‘This consultation process is a key step in the implementation of the pharmacovigilance legislation,’ said the European Medicines Agency.
Working on these detailed operational matters is also important given the goal of the new legislation is to make EU pharmacovigilance more efficient.
EMA stressed its impact on clarifying roles and responsibilities in the system, minimising duplication, rationalising and simplifying reporting and cleaning up rules on post-authorisation monitoring.
The paper includes some pointed questions. For instance, on the master file, it asks whether pharma companies should notify regulators of future significant changes, even though the new legislation has formally split master file contents from market authorisation.
It also asks whether to include copies of audit reports, and on monitoring it questions the potential risk of one member state handling all tasks (for authorisation, PSUR (periodic security update reports) scrutiny and Eudravigilance monitoring), rather than involving other governments.