EMEA RELEASES NEW GUIDANCE ON GENERIC APPLICATIONS

The European Medicines Agency (EMEA) has posted on its website new guidance for submitting applications for generic and hybrid pharmaceutical products.

A hybrid medicinal product is similar to a generic product, but hybrid products differ somewhat from reference drugs so clinical trial results are required to be submitted with the application.

This guidance provides clarifications on issues that are typically addressed during presubmission meetings, though the EMEA also emphasizes the importance of meetings. With the information in this document and through a successful presubmission meeting, sponsors should be able to submit applications in conformity with the agency's legal and regulatory requirements for fast evaluation, according to the guidance.

The EMEA urges applicants to contact the agency with questions, and there is a link to a presubmission meeting request form in the electronic document.

The deadline for comment on this guidance is Dec. 31, and the finalized version will go into effect Feb. 1, 2007. The guidance can be viewed at www.emea.eu.int/pdfs/human/euleg/22541106en.pdf.