EMA on SME Initiative

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] EMA published a report in late April reviewing commission regulation 2049/2005, which was adopted to promote innovation and the development of new medicines by small- to medium-sized enterprises (SMEs). This review came ten years after the reg- ulation was enacted in December 2005. Included in the report is a brief overview of registered SMEs, the engagement EMA has had with stakeholders, and the support provided for SMEs to date. This has included: ● regulatory assistance and SME briefing meetings ● training and regulatory awareness ● support for innovation of advanced therapy medicinal products, innovation task forces, scientific advice, and protocol assistance ● human medicinal products authorizations, and ● veterinary products.
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