EMEA SUGGESTS IMPROVEMENTS TO GUIDELINES FRAMEWORK

In order to improve the transparency of its regulatory decisions, prospective European Union (EU) drug agency EMEA is to improve the framework behind its guidelines on EU directives. The new policy is expected to improve cohesion with US FDA guidance documents and implement decisions by the International Conference on Harmonisation (ICH). ICH decisions are likely to have the same status as EU guidelines in the near future.

One step forward will be the reclassification of all EU guidance specifically as "guidelines," as much of the documentation which accompanies or clarifies EU directives is issued under various names.

The new format -- which is expected to become effective in September this year -- follows draft proposals originally published in the same month in 2004. Reports note that from that point EU guidelines are likely to be similar to their US FDA equivalents, although they are likely to carry a stronger legal force in case of violations.

Further, the Commission has also set out a 12-step programme for drawing up the guidelines. There will be no single mechanism for suggesting new initiatives, but rapporteurs will be appointed to the relevant member state and EMEA committees in order to refer requests for new guidance. Such requests are expected to be processed into "concept papers," which will then be open to public consultation for a period of up to six months. The resulting guideline will then usually become effective six months after publication on the EMEA website, and are unlikely to be retroactive unless in exceptional circumstances affecting medicines which are already marketed.