Implementing the New EU Legislation on Advanced Therapy Medicinal Products
This article was originally published in RAJ Devices
The large number of people who attended the European Medicines Agency’s first workshop on advanced therapy medicinal products reflects the interest of stakeholders for this rapidly evolving field. Around 160 individuals from regulatory authorities, industry and academia attended the much anticipated meeting, which took place in London on 3 April, a month after having been postponed due to severe weather conditions. Delegates from the EMEA and representatives from the EMEA’s new Committee for Advanced Therapies presented the key implementation aspects surrounding the relevant legislation, Regulation (EC) No 1394/2007 on Advanced Therapy Medicinal Products, which has been in force since 30 December 2008.
You may also be interested in...
Public Company Edition: Four health care special purpose acquisition vehicles went public and two others announced mergers, but only one biopharma firm priced an IPO during the week of 19-23 October. Replimune’s $250m offering led recent FOPOs.
Wholesalers are given three more years to set up electronic systems to verify saleable returns under another reprieve from the FDA. Yet the reprieve does not extend to manufacturers, who must respond within 24 hours to wholesalers’ requests to manually verify that a returned product is not suspect.
Agency explains how it will model vaccine authorization process on its licensing process for matters like inspections and lot release.