Guidelines on Non-Clinical Evaluation of Vaccines


On 6 October 2020, the Turkish Medicines and Medical Devices Agency published Guidelines on Non-Clinical Evaluation of Human Vaccines (Turkish language) to provide guidance on vaccine development procedures.

The guidelines regulate non-clinical evaluations and obtaining appropriate results from them, which are prerequisites for initiating clinical trials on a vaccine candidate. Non-clinical evaluation refers to all in vivo and in vitro tests performed before and during the clinical development of vaccines.

The guidelines advise on the following aspects of vaccine development:

  • Production, characterisation and quality of vaccine candidate.
  • Toxicology studies.
  • Primary and secondary pharmacodynamic studies.
  • Adjuvants, additives (excipients and preservatives).
  • Vaccine formulation and delivery device.
  • Alternative routes of administration.

The guidelines took effect from 6 October 2020.

First published by Practical Law, in 03.11.2020

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