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Guidance documents for CTGTP

Here is the list of guidance documents with relevant forms and templates to help you meet the regulatory requirements for dealing in cell, tissue or gene therapy products.

Product registration and post approval variation

Main guidance

Appendices

  1. Guideline on Notification Process for Class 1 Cell, Tissue or Gene Therapy Product252 KB
  2. Pre-Market Consultation for Class 2 Cell, Tissue or Gene Therapy Product Registration214 KB
  3. NDA Application Checklist for Class 2 Cell, Tissue or Gene Therapy (ICH CTD Format)54 KB
  4. NDA Application Checklist for Class 2 Cell, Tissue or Gene Therapy (ACTD Format)52 KB
  5. Sample Verification Document for Translator107 KB
  6. Target Processing Timelines for Class 2 CTGTP Applications104 KB
  7. Points to Consider for Class 2 CTGTP Labelling97 KB
  8. Chemistry, Manufacturing and Controls requirements for Cell, Tissue or Gene Therapy Product for Clinical Trials and Product Registration518 KB
  9. Guideline on the Submission of Risk Management Plan Documents112 KB
  10. Guideline on Minor Variation Application for Class 2 Cell, Tissue or Gene Therapy Products333 KB
  11. Variation Application Filing and Submission Enquiry Form71 KB
  12. MAV-1 Application Checklist for Class 2 Cell, Tissue or Gene Therapy (ICH CTD Format)48 KB
  13. MAV-1 Application Checklist for Class 2 Cell, Tissue or Gene Therapy (ACTD Format)48 KB

Safety monitoring and product recall

Post-Marketing Vigilance Requirements for CTGTP

Reporting product defects and recall CTGTP

Clinical trials

Refer to our clinical trials section for the guidance documents.

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