The European Medicines Agency develops scientific guidelines to help pharmaceutical companies and individuals to prepare marketing-authorisation applications for human medicines. This page lists relevant guidelines for applicants for advanced therapy medicinal products.
All of the below listed guidelines are available on the Agency's scientific guidelines pages as well as in the European Pharmacopoeia database and are listed because of their relevance to:
Please note that this list is not exhaustive and is only intended as guidance.
Gene therapy medicinal products
Web page | Relevant guidelines |
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Gene therapy |
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Biologicals: drug product |
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Biologicals: drug substance |
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Quality: ICH |
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Safety and efficacy: Biostatistics |
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ICH: considerations |
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Clinical safety and efficacy |
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Cell therapy and tissue engineering |
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Vaccines |
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European Pharmacopoeia | The following monograph from the European Pharmacopoeia (Ph. Eur) should be considered, where relevant:
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Cell-therapy and tissue engineering
Web page | Relevant guidelines |
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Cell-therapy and tissue engineering |
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Gene therapy |
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Biologicals: drug product |
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Biologicals: drug substance |
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Quality: Excipients |
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Quality: ICH |
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Safety: ICH | For non-clinical specific guidance, see
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Safety and efficacy: Biostatistics |
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Efficacy: ICH |
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Clinical safety and efficacy |
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European Pharmacopoeia | The following monographs from the European Pharmacopoeia (Ph. Eur) should be considered, where relevant:
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