Medical Writing Careers in medical writing Regulatory Matters

Volume 28, Issue 1 - Careers in medical writing

Regulatory Matters


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.


  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: 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: 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:



Careers in medical writing
President’s Message
How to get your first job as a medical writer
Educating the medical writer: A 5-year update
Cheeky medical writers: Transitioning from academia to medical writing
Making the leap: My move from academia to medical writing
From bench to pen: Life as a new medical writer
The grass is always greener on the other side
Pharmaceutical writer or CRO writer – choosing the right path
Career shift: Employment to freelancing
Medical writing and medical translation – two crossing paths
Career opportunities in medical device writing: Employee and freelance perspectives
Career shifts – surviving a change in geography
Grant writing and editing
1000 words in 1 picture
Medical writing at the management level
Thriving (and not just surviving) in a VUCA healthcare industry
Elevate your medical writing team to success
Clinical trial disclosure landscape and awareness in Japan
News from the EMA
Regulatory Matters
Gained in Translation
In the Bookstores
Medical Devices
Journal Watch
Veterinary Medical Writing
Good Writing Practice
Medical Communication
Regulatory Public Disclosure
Out on Our Own
Vignettes - Life After Medical Writing

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