AIFD Working Bodies

Innovation Policies SMC

AIFD Innovation Policies SMC prioritization and planning workshop took place as planned on June 18th, 2021. SMC headline goal, strategic priorities, internal working principles, 2021 IP SMC projects/initiatives and previous undertakings of the SMC were discussed. SMC agreed on defining “Support innovation driven entrepreneurships via AIFD BIO Startup program” and “Improve attractiveness of Turkey for clinical trials” as two key strategic priorities directly related to the SMC to drive “Making Turkey an Innovation Hub” imperative in the AIFD High-level roadmap.

Clinical Trials TF

TF Meeting 6 July 2021

AIFD Clinical Trials TF took place as planned on July 6th, 2021. Key outcomes of the meeting were as followed.

  • AIFD Legal Advisor shared information about the Informed Consent Form (BGOF):
    • Group members shared that, with the Pandemic, remote monitoring activities began and TITCK's documents were enabled to be viewed remotely, but with the open consent update made towards the end of 2020, TITCK did not take any action and directed it to KVKK. It was shared that the feedback from KVKK took a very long time.
    • AIFD Legal Advisor shared that a draft letter on retrospective studies has been prepared to be sent to the Personal Data Protection Board (KVKK).
  • Update on Clinical Research Action Plan Core Group studies:
    • Summary of the ongoing work of the core group (excel table) has been shared and distributed to the group members.
  • Request for a meeting with Clinical Research Department of TITCK:
  • Group members suggested to have a meeting with Mr. Gökhan Özkan from TITCK Clinical Research Department. Mr. Özkan has been invited to CT TF meeting to be held on August 3rd. Agenda items of the meeting is as follows:
    • Delayed translation of electronic surveys (eCOA) cause lack of full approval. Whether the conditional consent option be activated?
    • Continuation of the remote SDV/SDR facility after the Pandemic in line with the Pandemic Guideline
    • Is it possible to remove the conditions specified in the pandemic measures guide regarding the applications for adding centers and increasing the number of patients?
    • Supporting the operation of ethics committees (digitalization such as e-decisions)

Mutual Recognition Agreement (MRA) TF

  • AIFD MRA TF management team convened regularly in July to prepare a study as requested by TITCK during the June 23rd TITCK Consultation Meeting.
    • TITCK requested a study from industry associations regarding the countries where Turkey has high export potential, as well as a list of countries that are beneficial for Turkey to have a mutual recognition agreement with.
    • Based on this request, AIFD prepared a short list of countries to be prioritized for an MRA, based on import/export, GMP inspection impact as per the production site and number of products, as well as PIC/S membership.
    • Based on the legal opinion of AIFD Legal Advisor, AIFD also provided TITCK with this legal opinion to explain to Turkish authorities that it is not possible for individual EU member states to conclude mutual recognition agreements with other countries, in accordance with the EU Treaties, and that as a natural extension of technical legislation harmonization within the scope of the current Turkey-EU Customs Union Agreement, it should be carried out between Turkey and the EU Commission.