EMA news

The latest meeting of EMA’s Committee for Medicinal Products for Human Use (CHMP) has concluded with more than 15 positive opinions for new and generic drugs. Among other important announcements, the agency released a range of concept papers and guidelines for consultation and announced a safety review of orlistat-containing medicines.

During the meeting, which took place Sept. 19-22, 2011, CHMP adopted several concept papers from various working groups. Each of the following noteworthy adopted papers was opened for a 3-month public consultation period: the Biologics Working Party’s concept paper for a guideline on the quality of porcine trypsin used in the manufacture of human biological medicinal products; the Vaccine Working Party’s concept paper on revising guidelines for influenza guidelines; and the Biosimilar Medicinal Product Working Party’s paper on revising the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance. CHMP also adopted three new documents, two of which focused on guidelines for herbal medicines and one on revising an EMA clinical investigation guidance.