EMEA pledges EPAR revision, assessment report guidance document this year

The European Medicines Evaluation Agency has announced that thestructure of the European Public Assessment Report will be revised this year, and a guidance document on the structure and content of the assessment report published.

The new generation of EPARs will present the information in a sequential order of increasing complexity, which enables easier access in all languages, it says, and the guidance document, to be finalized after an EMEA workshop scheduled for second-quarter 1999, should result in EPARs which more consistently reflect the high-quality assessment process. The document, now under discussion at the Agency, will outline the benefit/risk assessment and decision-making process, including a description of the main issues raised in Committee on Proprietary Medicinal Products discussions, to allow the public to understand better the sequence of events leading to the opinion.

The changes were announced last month in a response to the International Society of Drug Bulletins, which had published a critical analysis of nine early EPARs. In the response, the head of the EMEA's Human Medicines Evaluation Unit, Rolf Bass, said the "innovative nature of the EPAR was bound to be difficult to create and implement. It has taken time to reach some maturity."