Category European Medicines Agency

EU launches Phase 2 of the Simultaneous National Scientific Advice (SNSA) pilot

The EU Innovation Network (EU IN) has launched Phase 2 of the simultaneous national scientific advice (SNSA) pilot. The EU IN started Phase 1 of the pilot for Simultaneous National Scientific Advice (SNSA) from the National Competent Authorities (NCAs) in February 2020. The pilot was extended to the end…

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European Commission establishes portfolio of ten most promising treatments for COVID-19

Last updated: 21 December 2021 The European Commission (EC) has established a portfolio of the ten most promising treatments for COVID-19. A group of independent scientific experts has screened 82 therapeutic candidates in late stage clinical development and identified 10 candidates as…

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EMA adopts guideline on quality documentation for medicinal products when used with a medical device

The European Medicines Agency (EMA) has adopted a guideline on quality documentation for medicinal products when used with a medical device. The guideline was adopted on 22 July 2021 and will come into effect on 1 January 2022. What is…

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EMA Q&A on the principles of GMP for the manufacturing of starting materials of biological origin for ATMPs

The EMA has published a Q&A on the principles of GMP for the manufacturing of startingmaterials of biological origin used to transfer genetic material for the manufacturing ofAdvance Therapy Medicinal Products (ATMPs). Is a GMP certificate required for manufacturing and…

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