Medical Writing Careers in medical writing Regulatory Matters

Volume 28, Issue 1 - Careers in medical writing

Regulatory Matters

Abstract

November 30, 2018 – EMA has published revised guidelines on the tests and studies needed to support marketing authorisation applications for certain haemophilia medicines. The revised guideline for haemophilia medicines for factor VIII deficiency was published in July 2018 and the revised guideline addressing medicines for factor IX deficiency was published today.

References

  1. European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Guideline on the Investigation of Bioequivalence. January 20, 2010 [cited 2018 Sep 10]. Available from: https://www.ema. europa. eu/documents/ scientific-guideline/guideline-investigationbioequivalence- rev1_en.pdf.
  2. Cardot J-M, Garcia-Arieta A, Paixao P, Tasevska I, Davit B. Implementing the additional strength biowaiver for generics: EMA recommended approaches and challenges for a US-FDA submission. Eur J Pharm Sci. 2018;111: 399–408.
  3. European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). ICH Guideline M9 on biopharmaceutics classification system based biowaivers: Step 2b. July 25, 2018 [cited 2018 Sep 10]. Available from: https://www.ema.europa.eu/documents/ scientific-guideline/ich-m9- biopharmaceutics-classification-systembased- biowaivers-step-2b-first-version_ en.pdf.
  4. Davit BM, Kanfer I, Tsang YC, Cardot J-M. BCS Biowaivers: Similarities and differences among EMA, FDA, and WHO requirements. The AAPS Journal 2016;18(3): 612–8 [cited 2018 Sep 10]. Available from: https://www.ncbi.nlm.nih.gov/pmc/ articles/PMC5256598/pdf/12248_2016_ Article_9877.pdf.
  5. Chen M-L, Blume H, Beuerle G, Davit B, Mehta M, Potthast H, et al. The Global Bioequivalence Harmonisation Initiative: summary report for EUFEPS international conference. Eur J Pharm Sci. 2018;111: 153–7.
  6. Drug Delivery Foundation. Provisional BCS Classification. (Database on webpage.) Available from: http://www.ddfint.net/search.cfm.

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