EMA Updates Two Pharmacovigilance Guidelines

Regulatory NewsRegulatory News | 11 August 2015 |  By 

Today, the European Medicines Agency (EMA) released two revised guidelines, one final and one draft, to clarify certain aspects of pharmacovigilance in the EU.

The two guidelines include a draft version of Module VIII – Post-Authorisation Safety Studies (Rev 2), which is expected to come into effect in early 2016, and Module IV – Pharmacovigilance Audits (Rev 1), which takes effect on 12 August 2015.


Pharmacovigilance is the process of monitoring the use of drugs after they have entered the market. In particular, regulators, companies and healthcare providers are responsible for monitoring drugs and reporting suspected adverse events. This information is incredibly important to ensuring patient safety after a product has been approved.

The primary legal basis for pharmacovigilance requirements in the EU are found in Article 57 of Regulation (EC) No. 726/2004 and Title IX of Directive 2001/83/EC. In 2010 and 2012, the EU introduced new directives and regulations amending its pharmacovigilance requirements, which are collectively known as the new pharmacovigilance legislation.

Changes to Module VIII

The changes to Module VIII – Post-Authorisation Safety Studies (Rev 2) are mostly made to "clarify the link between the legislation on non-interventional post-authorisation safety studies (PASS) and categories 1-4 of non-interventional PASS for risk management planning."

Section VIII.A has been updated to include a list of reasons why a PASS may be required, including:

  • "imposed as an obligation in accordance with REG Art 9 and Art 10a and with DIR Art 21a and Art 22a (category 1 of studies in GVP Module V);
  • imposed as a specific obligation in the framework of a marketing authorisation granted under exceptional circumstances (category 2 of studies in GVP Module V);
  • required in the risk management plan (RMP) to investigate a safety concern or to evaluate the effectiveness of risk minimisation activities (category 3 of studies in GVP Module V); and
  • those that may provide safety information of less significance (category 4 of studies of GVP Module V)"

Section VIII.B.2 is also updated to include information on registering PASS in the EU electronic register of post-authorization studies (EU PAS Register). The guideline features a revised section on situations where certain adverse events are not collected in PASS, and how companies should justify their approach to safety data collection.

Additionally, the guideline includes updated sections explaining the procedures for imposing PASS on companies in the EU, as well as a revised section on changes to the marketing authorization based on the results of a non-interventional post-authorization safety study.

Changes to Module IV

The changes to Module IV – Pharmacovigilance Audits (Rev 1) are relatively minor. The only content change to the document is a clarification on activities that do not constitute an audit.

The guideline defines an audit as "a systematic, disciplined, independent and documented process for obtaining evidence and evaluating the evidence objectively to determine the extent to which the audit criteria are fulfilled, contributing to the improvement of risk management, control and governance processes."

Now, an explanation has been added stating that "benchmarking, reviews of qualifications, risk assessment questionnaires, surveys or other activities in which evidence of fulfilment of pharmacovigilance requirements is not independently obtained and evaluated, would not be regarded as an audit."

EMA says the document has also been updated to match the editorial style of other good pharmacovigilance practice (GVP) guidelines.

Introductory Note on Pharmacovigilance, Module IV, Module VIII


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