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Regulatory Focus™ > News Articles > 2019 > 11 > Should Medicines With a PASS be Excluded From Additional Monitoring? EC Says Not Yet

Should Medicines With a PASS be Excluded From Additional Monitoring? EC Says Not Yet

Posted 18 November 2019 | By Zachary Brennan 

Should Medicines With a PASS be Excluded From Additional Monitoring? EC Says Not Yet

The European Commission on Friday sent a report to the European Parliament and the Council on medicines that are subject to additional pharmacovigilance monitoring, including what has happened since monitoring obligations were expanded in 2010 and 2012, and what the future may hold.

During the 2012 revision of the legislation, the mandatory scope of the additional monitoring list was extended to certain medicines with specific post-authorization obligations, including products for which a post authorization safety study (PASS) was requested. In 2013, Europe also added an inverted black triangle in the package leaflet to more clearly indicate which medicines are subject to additional monitoring.

A survey of EU member states found, according to a European Medicines Agency (EMA) report, that some countries said the inclusion of medicines with an imposed PASS in the additional monitoring list “leads to a large number of medicines which have been on the market for many years being subject to additional monitoring. Some Member States questioned the added value in these cases and the possibility for misunderstanding the reason for inclusion of the black triangle in the product information.”

In December 2016, EMA created a list of medicines under additional monitoring, which included a total of 2099 medicines, 88% of which were because of an imposed PASS.

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) also “indicated its support for the reconsideration of the scope of the additional monitoring obligations, in particular the mandatory inclusion of products subject to imposed PASS,” the EC noted. And in the conclusion of the EMA report, the agency said that the “inclusion of imposed PASS as a mandatory trigger for additional monitoring leads to large numbers of established products being included in the list and is of limited value.”

The PRAC also noted possible cases where a PASS might be imposed on one product while other similar products do not have a PASS, although only the medicine with a PASS would be included in the additional monitoring list.

Despite the questions raised by the EMA and PRAC, the EC said it “does not consider that these concerns require an immediate review of the legislation but evidence on the implementation and impact of additional monitoring can be considered as appropriate in any future review of the legislation.”

The EC also called on competent authorities to continue to collect data on medicines under additional monitoring and strengthen the evidence base to allow for future assessments “with respect to medicines with the same active substance, as well as experience concerning medicines with an imposed PASS.”



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