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tillstånds- eller tillsynsmyndighet

regulatory authority [ENGLISH]

A body that carries out regulatory activities relating to medicines, including the processing of marketing authorisations, the monitoring of side effects, inspections, quality testing and monitoring the use of medicines.

tillstånds- eller tillsynsmyndighet [SWEDISH]

Myndighet som bedriver tillstånds- och tillsynsverksamhet som rör läkemedel, inklusive försäljningstillstånd, övervakning av biverkningar, inspektioner, kvalitetstestning och övervakning av läkemedelsanvändning.


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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