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guidance document [ENGLISH]

Statement that offers interpretation or advice on a regulatory procedure or policy in order to support compliance with regulation/law, but does not outline specific requirements or standards.

vägledningsdokument [SWEDISH]

Uttalande som ger tolkning eller råd om ett regulatoriskt förfarande eller policy för att stödja efterlevnad av förordning/lag, men som inte beskriver specifika krav eller standarder.


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
  2. 2. Clinical Trials Information System
  3. 3. EMA Glossary of Regulatory Terms
  4. 4. EMA Medical Terms simplifier
  5. 5. Glossary of Terms used in EU Clinical Trials Register
  6. 6. Glossary of Terms U.S Food and Drug Administration
  7. 7. National Human Genome Research Institute “Talking Glossary of Genomic and Genetic Terms”
  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

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