On 11th of Aug 2015, European drug regulatory authority the European Medicines Agency (EMA) published two modified guidelines, one final and one draft, to simplify specific aspects of pharmacovigilance in Europe.
The two guidelines are a draft type of Module VIII – Post-Authorisation Safety Studies (PASS) (Rev 2), which is expected to come into effect in the beginning of next year, and Module IV – Pharmacovigilance Audits (Rev 1), which will be effective from 12 August 2015.
Pharmacovigilance is the approach of tracking the adverse effects and use of pharmaceutical medicines and devices after they have entered the market. To be specific, regulatory authorities and healthcare providers are liable for tracking drugs in the market and reporting adverse events. This data is extremely significant to making sure patient safety after a drug/device has been approved for marketing.
The main legal foundations for pharmacovigilance specifications in Europe are found in Article 57 of Regulation (EC) No. 726/2004 and Title IX of Directive 2001/83/EC. In 2010 and 2012, the EMA launched new directives and regulations modifying its pharmacovigilance specifications, which are together called the new pharmacovigilance legislation.
Modifications to Module VIII
The modifications to Module VIII – PASS (Rev 2) are mainly made to “explain the association among the regulation on non-interventional PASS and categories 1-4 of non-interventional PASS for risk management planning.”
Section VIII.A has been modified to add a list of reasons why a PASS may be needed.
Section VIII.B.2 is also modified to add information on enrolling PASS in the EU electronic register of post-authorization studies (EU PAS Register). The guideline attributes a revised section on conditions where specific adverse events are not gathered in PASS, and how organizations should justify their method to safety data collection.
In addition, the guideline contains updated sections describing the processes for imposing PASS on organizations in the EU; along with a modified section on changes to the marketing authorization dependent on the outcomes of a non-interventional PASS.
Modifications to Module IV
The modifications to Module IV – Pharmacovigilance Audits (Rev 1) are comparatively minor. The only content modified in the document is a clarification on activities that do not represent an audit.
The guideline describes an audit as “a systematic, disciplined, independent and documented procedure for acquiring proof and assessing the proof objectively to figure out the extent to which the audit requirements are fulfilled, contributing to the enhancement of risk management, control and governance processes.”
Now, a description has been included stating that “benchmarking, reviews of qualifications, risk evaluation surveys, questionnaires for other activities in which proof of fulfillment of pharmacovigilance specifications is not independently acquired and evaluated, would not be considered as an audit.”
EMA states that the document has also been modified to match the editorial style of other good pharmacovigilance practice (GVP) guidelines.