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European medicines regulatory network

European medicines regulatory network [ENGLISH]

The system for regulating medicines in Europe is based on a closely coordinated regulatory network of national competent authorities in the Member States of the European Economic Area working together with the European Medicines Agency and the European Commission. 

European medicines regulatory network [SWEDISH]

Systemet för att reglera läkemedel i Europa bygger på ett nära samordnat tillsynsnätverk av nationella behöriga myndigheter i medlemsstaterna i Europeiska ekonomiska samarbetsområdet som arbetar tillsammans med Europeiska läkemedelsmyndigheten och Europeiska kommissionen.


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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