What EMA Reflection Paper on CRISPR Genome Editing - Quality Considerations, Off-Target Analysis, Manufacturing Controls, Non-Clinical Studies and Regulatory Classification for Gene-Edited Products requires
This reflection paper provides scientific considerations for the development of CRISPR-based gene-edited medicinal products, focusing on quality, off-target analysis, manufacturing controls, and non-clinical evaluation. It applies to applicants developing advanced therapy medicinal products (ATMPs) in the EU and references the framework established in Directive 2001/83/EC and Regulation (EC) No 1394/2007.
Pillar: Biotech & Genomics · Authority: European Medicines Agency (EMA) · Version: 1.0.1 · Last updated:
Primary source: https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/scientific-guidelines
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Primary Citations — 5 traced to source
- Scientific guidelines - Status of EMEA scientific guidelines and European pharmacopoeia monographs and chapters in the regulatory framework applicable to medicinal products Reference Number: EMEA/42371/2008
- Scientific guidelines - The European Medicines Agency's Committee for Medicinal Products for Human Use prepares scientific guidelines in consultation with regulatory authorities in the European Union (EU) Member States
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