Masterarbeit
The (European) Public Assessment Report as an extended part of the European application procedure - Regulatory background and practical considerations
Thurid Buch, geb. Fassbender (2006)
Language: English
European Public Assessment Reports (EPARs) describe the steps, reasons, and commitments for the approval of a given drug, and the summaries of product characteristics. In general, they represent the technical documents that report indications and adverse reactions for each drug.
The EPAR is published on all medicinal products for newly licensed products under the Centralised Procedure (CP) whereas the Public Assessment Report (PAR) is written for medicinal products authorised under the Decentralised Procedure (DCP). The scientific conclusions reached at the end of the centralised and decentralised evaluation process are reflected by EPARs and PARs respectively. They are made available to the public by the EMEA after deletion of any commercially and confidential information.
These assessment reports are intended for all those involved with the safe and proper use of the medicinal product, i.e. healthcare professionals, patients and their family and carers. Some knowledge of medicines and diseases is expected of the latter category as the language in this report may be difficult for laymen to understand.
EPARs and their summaries will be updated by a following addendum throughout the authorisation period as changes to the original terms and conditions of the authorisation are made and whenever new information becomes available. A reflection paper on EPAR summaries for the public is available under http://www.emea.eu.int/pdfs/human/euleg/12675705en.pdf.
The EMEA has started a project to replace existing EPAR abstracts with EPAR summaries for all human medicinal products that are already authorised; this project is expected to be finalised by the end of 2006. As each summary is prepared, the Marketing Authorisation Holder will be informed and will have the opportunity to see it before publication.
One scope of this paper was to review the current scientific assessment process with emphasis on transparency measures and consider ways in which it may change over the next 5 to 10 years.
The development of PAR and EPAR is one of the measures introduced into the EU legislation to meet the requirement of more transparency for the public. The scientific assessment process should always aim at protecting public and animal health. An evaluation of the collaboration of the member states and their Rapporteurs in the assessment process across all regulatory systems, including the CP, the Mutual Recognition Procedure (MRP) and the new DCP has been performed. It is deemed important to include all licensing procedures to ensure one consistent standard in the European network of Medicines Agencies. This would ensure high quality assessment regardless of the procedure and thus earn the confidence of the European citizens. The safety, quality and efficacy of medicines, both for human and veterinary use that are on the European market would thus correspond to an appropriate standard to inform health care professionals and patients in Europe on a global harmonised level.