EMA SME Office Newsletter – Issue 49

On 7 May 2020 the EMA published the SME Office newsletter for small and medium-sized enterprises (SMEs).

The SME Office was set up within the EMA to address the particular needs of smaller companies. It provides information for SMEs on the EU regulatory environment for medicines. In Issue 49, the news bulletin includes regulatory guidance on COVID-19 treatments under investigation, managing clinical trial data, scientific guidelines for human medicines, pharmacovigilance, updated regulatory guidance, medical devices regulation, advanced therapy medicinal products, GMP and other news.

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