On 18 May 2021, the Turkish Medicine and Medical Devices Authority (TİTCK) updated the Guidelines on Non-Clinical Assessment for Vaccines (“Guidelines“). The Guidelines were developed following feedback from the healthcare industry. The update contains detailed guidance on various issues that were left unclear in the previous version of the Guidelines. The Guidelines are available here (in Turkish).
The most notable aspects of the update are the following:
- Vaccine research groups must respect the welfare of the experimental animal during vaccine trials. To this end, non-clinical vaccine trials on experimental animals must be conducted by taking 3R (reduce, refine, replace) principles into consideration.
- Quality tests concerning characterization of pharmacopeia monographs must be prepared in light of both national and international guidance, such as from the World Health Organization (WHO), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the Food and Drug Organization (FDA). If such guidance lacks necessary information, vaccine research groups should consider in-house specifications.
- Stability tests must be conducted under long-term, accelerated and stress circumstances with products produced in accordance with the Good Manufacturing Practices (GMP). An adequate amount of data must be submitted in order to support the stability of the products during the clinical research.
- In the event of a public health emergency, the stability data must not be less than fifteen days in order to start clinical researches. The stability tests realized under product storage and acceleration circumstances must be continued during the clinical trial, and their findings must be submitted to TİTCK.
- Toxicology studies for vaccine candidates that are in an earlier phase than Stage 2 must be carried out and finalized prior to human trials.As a general rule, vaccine candidates do not require genotoxicity studies. However, vaccine candidates that risk affecting the human genome may require genotoxicity studies depending on their formulation.
TİTCK continues to provide useful guidance for companies working on vaccines. All relevant companies working in this field should carefully follow TİTCK’s announcements and take the necessary steps to fulfil their obligations.