Is there any further guidance or information for Small and Medium sized Enterprises (SMEs)?
SMEs developing ATMPs can approach the EMEA for advice and guidance through the SME office or the Innovation Task Force (ITF). The activities of the ITF include ATMPs, but also other emerging therapies and technologies. One of ITF objectives is to establish a platform for early informal dialogue with companies, particularly SMEs, to proactively identify scientific, legal and regulatory issues. To this end, SMEs may request a briefing meeting with the ITF to discuss legal, regulatory or scientific issues for selected product(s) in their pipeline. These may be organised in cooperation with specialised EMEA Committees/Working Parties. In addition, the ITF can provide regulatory advice to applicants on the eligibility for access to EMEA procedures (such as scientific advice and the centralised procedure for marketing authorisation) as a medicinal product ( e.g. when there are uncertainties as to whether a product would qualify as a medicinal product). Further information on how to contact
