AIFD Working Bodies

Health Science Policies

Reliance Working Group Meeting
Reliance Working Group conducted its monthly meeting on 01.07.2021. The frame of preparing the position paper on reliance was discussed. As an additional input for the position paper, to conduct a survey on variation procedures was decided. Holding an Access Consortium was also discussed to make TITCK more aware of reliance with the support of a speaker from EFPIA.

EFPIA AIFD Regulatory Town Hall

Quarterly EFPIA AIFD Regulatory Town Meeting was held on 02.07.2021. Latest updates were shared by AIFD including the position of AIFD and recent meetings with stakeholders on below topics;

  • GMP Prioritization Process
    • AIFD Position: Scientific and economic situations should be evaluated separately.
    • Meetings with; Deputy MoH Tolga Tolunay, President of TITCK Tolga Karakan, Deputy President of TITCK Elif Hilal Vural
  • Biosimilar Products Guideline
    • AIFD Position: Focus of every health-related issue should primarily be the "patient" and "patient safety". Regulatory evaluation needs to be based on international standards and scientific facts.
    • Meetings with; Deputy MoH Tolga Tolunay, President of TITCK Tolga Karakan, Deputy President of TITCK Elif Hilal Vural
  • MRA
    • As a request of TITCK, possible countries to be selected in accordance with data from AIFD members, the legal side and comments from EFPIA.
    • UP-TO-DATE information: AIFD MRA TF 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 and presented to TITCK. Please refer to Innovation Policies SMC notes for further information.
  • Reliance
    • AIFD Position: Using Reliance Models will accelerate the approval timelines.
    • EFPIA will support AIFD to conduct a reliance workshop for TITCK.

In addition to the updates from AIFD, EFPIA shared latest information regarding IFPMA Reliance toolkit and WHO Biosimilar Guidelines revisions.

For all the details of the meeting, Webex is accessible via below link;

Merck & Co Inc WebEx Enterprise Site - Replay Recorded Meeting

Economy Reform Package (ERP) Suggestions on Biotechnology

As an outcome of the “Smart Life and Health Roadmap” meeting that was held on 17th of June, stakeholder comments and suggestions were requested by TUSSIDE regarding “R&D, Access to International Markets and Commercialization on Biotechnology” within the scope of Economy Reform Package (ERP).

The suggestions list was prepared with the comments received from AIFD Biotherapeutic TF, Regulatory TF and SMC members. Stakeholder information was also added to the list and shared with TUSSIDE for their further evaluation on 13.07.2021