June 2021 – In May 2021, the Turkish Medicine and Medical Devices Authority ("TITCK") made two regulatory updates in the pharmaceutical sector in response to feedback from sector participants.
On 6 May 2021, TITCK issued an announcement (the "Announcement") providing details regarding the notification to TITCK of transfers of value by market authorisation holders ("MAHs") under certain circumstances. Subsequently, on 18 May 2021, TITCK updated the Guidelines on Non-Clinical Assessment for Vaccines (the "Guidelines"), which were first brought into force on 6 October 2020.
Announcement on Transfers of Value
The Announcement, firstly, clarifies the notification process relating to transfers of value within the context of scientific meetings/product-promotion meetings that had been pre-approved by TITCK before 20 March 2020 but did not take place due to the administrative measures in response to the COVID-19 pandemic, which postponed all types of indoor and outdoor events relating to scientific, cultural or artistic meetings.
The Announcement states that if a payment was made by a MAH for such scientific or product-promotion meetings to entities or agencies hosting the event, such as a service fee, late cancellation fee or deduction of expenses, the MAH will notify (i) any amounts that relate to the registration, accommodation and transportation of invitees as transfers of value to the healthcare professionals, and (ii) all other amounts relating to the meeting (such as satellite symposium, booth participation, general sponsorship and related deductions/penalties/service fees) as transfers of value to the healthcare institution.
Secondly, the Announcement provides details for the notification process for donations made by the MAHs through the Provincial Health Directorates (the "Directorates"). It states that any donation made to any Directorate will be notified as a transfer of value to the relevant Directorate, while any donations made in line with the guidance of the Directorates to a healthcare institution operating within the borders of the relevant province will be notified as a transfer of value to the relevant healthcare institution.
Finally, the Announcement provides that any donation made by a MAH to healthcare institutions through associations or unions (such as the Association of Research-Based Pharmaceutical Companies and the Pharmaceutical Manufacturers Association of Turkey) of which the MAH is a member, will be notified as a transfer of value to the relevant association or union.
Update to the Guidelines
The general outline of the update is as follows:
- Studies to be carried out on experimental animals are to be planned by considering the 3R (reduce, refine, replace) principles.
- Both the relevant national and international guidelines (e.g., those issued by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the European Medicines Agency (EMA), the US Food and Drug Organization (FDA), the World Health Organization (WHO)) must be taken into consideration when planning quality control tests in regard to the characterisation of pharmacopeia monographs. If there is no information in such guidelines about the vaccine candidate and the methods to be used, in-house specifications and their limit values should be determined.
- Stability tests shall be conducted with the product manufactured according to Good Manufacturing Practices (GMP) under long-term (product storage conditions), accelerated and stress (if necessary for the vaccine candidate) conditions. Sufficient data (stability protocol and available stability data, including the data submission schedule) shall be submitted to support the stability of the product throughout the clinical trial.
- In a public health emergency situation, the stability data of not less than fifteen days is acceptable to initiate clinical trials. However, while the clinical trial is being conducted, stability tests carried out under the storage conditions and accelerated conditions of the product should continue to be carried out and the data obtained should be submitted to TITCK.
- Toxicity studies will be conducted and completed for the vaccine candidate being developed prior to phase 2 studies.
- Genotoxicity studies are not normally required for vaccine candidates. However, a genotoxicity study is required if it is likely to affect the human genome according to the formulation of the vaccine candidate (e.g., DNA vaccines and vaccines containing nucleic acid chain adjuvants).
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