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June 2021 – In May 2021, the Turkish Medicines and Medical Devices Authority (“TITCK“) carried out two regulatory updates in the pharmaceutical sector in response to comments from industry participants.
On May 6, 2021, TITCK posted an announcement (the “Ad“) providing details of the notification to TITCK of transfers of value by marketing authorization holders (“TAMM“) under certain circumstances. Subsequently, on May 18, 2021, TITCK updated the Guidelines for the Non-Clinical Evaluation of Vaccines (the”Guidelines“), which entered into force for the first time on October 6, 2020.
Announcement on value transfers
The Announcement, as a first step, clarifies the notification process relating to transfers of value within the framework of scientific meetings / product promotion meetings which had been pre-approved by the TITCK before March 20, 2020 but did not occurred due to administrative measures in response to the COVID-19 pandemic, which postponed all types of indoor and outdoor events related to scientific, cultural or artistic meetings.
The announcement indicates that if a payment has been made by a MA holder for such scientific or product promotion meetings to entities or agencies organizing the event, such as service charge, late cancellation fee or a deduction of expenses, the MA holder will notify (i) all amounts related to the registration, accommodation and transportation of guests as value transfers to healthcare professionals, and (ii) all other amounts related to the meeting (such as satellite symposium, booth attendance, general sponsorship and deductions / penalties / related services fees) as transfers of value to the healthcare facility.
Second, the announcement provides details of the process for notifying donations made by MAHs through the Provincial Health Directorates (the “Directions“). It stipulates that any donation made to a directorate will be notified as a transfer of value to the directorate concerned, while any donation made in accordance with the directives of the directorates to a health establishment operating within the borders of the province concerned will be notified as a transfer of value to the health facility concerned.
Finally, the announcement provides that any donation made by a MA holder to healthcare institutions through associations or unions (such as the Association of Research-Based Pharmaceutical Companies and the Association of pharmaceutical manufacturers of Turkey) of which the MA holder is a member, will be notified as a transfer of value to the association or trade union concerned.
Update of the guidelines
The general diagram of the update is as follows:
- Studies to be carried out on laboratory animals should be planned taking into account the principles of the 3Rs (reduce, refine, replace).
- Relevant national and international guidelines (for example, those issued by the International Council for the Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), the European Medicines Agency (EMA), the Organization of States United for Food and Drugs (FDA), World Health Organization (WHO)) should be taken into consideration when planning quality control testing with respect to the characterization of pharmacopoeia monographs. If these guidelines do not contain information on the candidate vaccine and the methods to be used, the internal specifications and their limit values should be determined.
- Stability tests must be carried out with the product manufactured according to Good Manufacturing Practices (GMP) under long-term (product storage conditions), accelerated and stress conditions (if necessary for the vaccine candidate). Sufficient data (stability protocol and available stability data, including data submission schedule) should be submitted to support product stability throughout the clinical trial.
- In a public health emergency, stability data of at least fifteen days are acceptable to initiate clinical trials. However, during the duration of the clinical trial, stability tests performed under storage conditions and accelerated conditions of the product should continue to be performed and the data obtained should be submitted to TITCK.
- Toxicity studies will be conducted and completed for the candidate vaccine under development prior to phase 2 studies.
- Genotoxicity studies are not normally required for candidate vaccines. However, a genotoxicity study is required if it is likely to affect the human genome depending on the formulation of the candidate vaccine (eg, DNA vaccines and vaccines containing nucleic acid chain adjuvants).
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