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EFA at the PCWP of the European Medicines Agency (EMA)

On the 28th of February, EFA attended one of the periodical joint meetings of the PCWP and the Healthcare Professionals’ Working Group (HCP WG) at the EMA in London. EFA, which has been taking part in these meetings since March 2010, together with 14 other patient and consumer representative organisations, was represented by Lina Buzermaniene, EFA’s regular representative, and Roberta Savli.

During the meeting, several questions arose for which the contribution of patients’ organisations was requested and very much appreciated. In particular, patients’ point of view was sought in order to optimise the revision of the Questions and Answers (Q&A) on biosimilar medicines (i.e.: medicine similar to a biological medicinal product that has already been authorised; the active substance of the biosimilar medicinal product is similar to the one of the biological medicine). In addition, the template of the Summary of Product Characteristics (SmPC: text describing the properties of a medicinal product, made available to all prescribing physicians in the EU. It differs from the Package Leaflet (PL) that is written for the patient) and its patient-friendly aspects were discussed. Other subjects discussed were the European Clinical Trials Register, launched last 22nd of March 2011, the outcomes of the consultation on additional monitoring of medicines and adverse drug reaction report, and the involvement of patients in the Scientific Advisory Groups (SAGs).

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