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undantag från skyldigheten att lämna in en pediatrisk prövningsplan för en läkemedelsklass

class waiver [ENGLISH]

An exemption from the obligation to submit a paediatric investigation plan for a class of medicines, such as medicines for diseases that only affect adults. Class waivers are adopted by the Paediatric Committee (PDCO). 

undantag från skyldigheten att lämna in en pediatrisk prövningsplan för en läkemedelsklass [SWEDISH]

Ett undantag från skyldigheten att lämna in en pediatrisk prövningsplan för en läkemedelsklass, till exempel läkemedel mot sjukdomar som endast drabbar vuxna. Dessa undantag ('waivers') antas av Pediatric Committee (PDCO).

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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