EMEA makes information more accessible to patients
Simple summaries of European Medicines Agency pre-licensing medicines assessment reports are now being published by the EMEA.
The aim of the summaries is to make understandable information on new
medicines available to patients and the public.
Called “EPAR
summaries for the public”, they are short, non-technical
versions of the full European public assessment reports (EPARs) currently
published for all centrally authorised products. Each summary provides
information about how the medicine works, its indications, how it was
studied, its benefits and risks, and the reasons why it received a positive
recommendation for authorisation from the EMEA.
The summaries are written in a question-and-answer format, and are intended
to give the general public enough information to understand the basis
for the granting of the marketing authorisation.
The publication of EPAR summaries is one of the new provisions of European
pharmaceutical legislation concerning the availability of better information
about medicines.
In the first instance, the summaries will only be published for newly
authorised medicines, but the database will gradually be built up to
include retrospective summaries for all centrally authorised medicines.
The first group of medicines to be included in the catching-up exercise
will be medicines acting on the alimentary tract and metabolism.
The first summaries to be published are for Ionsys and Yttriga. |
The
Pharmaceutical Journal
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