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regulatorisk harmonisering

regulatory harmonization [ENGLISH]

process by which regulations in different jurisdictions are adapted to become more aligned or compatible, usually through a process of active negotiation between regulatory agencies or other state representatives

regulatorisk harmonisering [SWEDISH]

Process genom vilken regleringar i olika jurisdiktioner anpassas och blir mer kompatibla, vanligtvis genom en process av aktiv förhandling mellan tillsynsmyndigheter eller andra statliga representanter.


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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