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produkt för regenerativ medicin

Regenerative Medicine Product [ENGLISH]

Descriptor used by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) to refer to products that are: 1) processed (more than minimal manipulation) live human/animal cells that are intended to be used for either the reconstruction, repair, or formation of structures or functions of the human body or the treatment or prevention of human diseases; or 2) used for gene therapy.

produkt för regenerativ medicin [SWEDISH]

Deskriptor som används av Japans myndighet för läkemedel och medicintekniska produkter (PMDA) för att hänvisa till produkter som är: 1) bearbetade (mer än minimal manipulation) levande celler från människa eller djur som är avsedda att användas för antingen rekonstruktion, reparation eller bildning av strukturer eller funktioner i människokroppen eller behandling eller förebyggande av sjukdomar hos människor, eller 2) som används för genterapi.

2024-01-29

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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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