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läkemedel för avancerad terapi (ATMP)

advanced therapy medicinal product [ENGLISH]

Type of treatment intended for use in humans that is either classified as a gene therapy, somatic cell therapy or tissue-engineered product, or a combination of these products with medical devices. A medicine for human use that is based on genes, cells or tissue engineering.

läkemedel för avancerad terapi [SWEDISH]

Ett läkemedel för genterapi enligt definitionen i del IV i bilaga I till direktiv 2001/83/EG, eller ett läkemedel för somatisk cellterapi enligt definitionen i del IV i bilaga I till direktiv 2001/83/EG, eller en vävnadsteknisk produkt enligt definitionen i punkt b.

2024-01-29

Resources and references

Definitions have been translated into the Swedish language from the following sources:

  1. 1. American Society of Gene and Cell Therapy Glossary https://www.asgct.org/education/more-resources/glossary
  2. 2. Clinical Trials Information System https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/clinical-trials-human-medicines/clinical-trials-information-system
  3. 3. EMA Glossary of Regulatory Terms https://www.ema.europa.eu/en/about-us/glossaries/glossary-regulatory-terms
  4. 4. EMA Medical Terms simplifier https://www.ema.europa.eu/en/documents/other/ema-medical-terms-simplifier_en.pdf
  5. 5. Glossary of Terms used in EU Clinical Trials Register https://www.clinicaltrialsregister.eu/doc/EU_Clinical_Trials_Register_Glossary.pdf
  6. 6. Glossary of Terms U.S Food and Drug Administration https://www.fda.gov/patients/clinical-trials-what-patients-need-know/glossary-terms
  7. 7. National Human Genome Research Institute “Talking Glossary of Genomic and Genetic Terms” https://www.genome.gov/genetics-glossary/m#glossary
  8. 8. The Glossary for Advanced Therapies Regen. Med. Dec 2020 Vol. 15 No. 12 Suppl. 1
  9. 9. Toolkit For Patient Focused Therapy Development Glossary https://toolkit.ncats.nih.gov/glossary-2/

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