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Are you ready for the New Pharmacovigilance Legislation?

New Pharmacovigilance Legislation

As the European Medicines Agency finalizes the first set of Good Pharmacovigilance Practices are you ready for the Transition to the New PV Legislation?

As the time draws closer for the new European pharmacovigilance legislation to take effect on 2 July 2012, many marketing authorization holders will be concerned that only seven of the long awaited good pharmacovigilance practice (GVP) modules have been finalized and published so far. Drafts of a further two GVP modules have been released for public consultation this week, however, drafts of a further seven GVP modules are still awaited.

The planned changes are far reaching and the European Medicines Agency (EMA) has recognized that not all measures will be implemented by the July 2012 deadline. This delay in provision of the new GVP guidance documents raises both legal and practical questions for marketing authorization holders as regards the date from which the new rules apply.

In response the EMA has published a question-and-answer (Q&A) document which provides guidance on some of the practical considerations during the transitional phase to the new pharmacovigilance legislation (Regulation (EU) No 1235/2010 and Directive 2010/84/EU).

The Q&A applies to all medicinal products for human use regardless of the route of authorisation. The questions currently cover the following topics and will be regularly updated as the implementation progresses:

• Good pharmacovigilance practices (GVP) guideline
• Pharmacovigilance system master file (PSMF) and summary of the pharmacovigilance system
• Risk management plan (RMP)
• Post-authorization safety studies (PASS)
• Periodic safety update reports (PSUR) and European Union reference date (EURD) list
• Literature monitoring
• Product information and black symbol
• Adverse drug reaction (ADR) reporting and signal management
• Renewals

So what of the remaining seven modules?

The EMA has been forced to prioritize the implementation of the pharmacovigilance legislation due to budget and resource restrictions. Activities contributing to public health have been assigned the highest priority, followed by activities increasing transparency and improving communication and then activities that simplify processes.

Deliverables classified as Priority “A” are to be delivered in 2012, whereas Priority “B” items will not be delivered until post 2012, well past the 02 July 2012 deadline originally set.

Details of the EMA and Member States Joint Implementation Check-list, which provides an overview of the prioritization of tasks towards implementation of the legislation can be found here

Missing Modules

The remaining modules yet to be seen in draft form are:

  • Module IV: Audits
  • Module XI: Public Participation in Pharmacovigilance
  • Module XII: Continuous Pharmacovigilance, Ongoing Benefit-Risk Evaluation, Regulatory Action and Planning of Public Communication
  • Module XIII: Incident Management
  • Module XIV: Referral Procedures for Safety Reasons
  • Module XV: Safety Communication
  • Module XVI: Tools, Educational Materials and Effectiveness Measurement for Risk minimization

Modules IV, XV and XVI have an ‘A’ priority against certain tasks, so hopefully we will receive further guidance later this year. The timeframe appears less clear for the remaining modules and the current transitional arrangements Q & A document does not elaborate on these areas either. Whilst the missing guidance in these modules is not likely to impact timelines for clinical trial and marketing authorization approvals it does delay processes and procedures that will deliver a greater transparency in drug safety to the general public. What is without question is the fact that the staggered approach in delivering the new GVP guidance documents will create a significant administrative burden for marketing authorization holders, sponsors and contract research organizations alike as they all aim to update their standard operating procedures through numerous iterations in order to maintain compliance.

Should you require assistance in ensuring your pharmacovigilance service is compliant with the new legislation Quanticate’s team of pharmacovigilance experts would be pleased to advise. Contact us at enquiries@quanticate.com


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