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RELIANCE IMPLEMENTATIONS

The Reliance Practices Working Group, which was established with the participation of volunteers from our Health Science Policies Strategic Management Committee, continued its activities in 2022 within the scope of the following 2 topics:

  1. Contributing to the TITCK within the scope of its strategy to become a reference authority
  2. Establishing an AIFD position in line with international standards

Reliance İmplementations Working Group has monthly regular meetings. The notable activities of the WG are listed below:



AIFD has worked intensively and thas aken initiatives for the implementation of Reliance Practices in the regulatory licensing process. These initiatives yielded results and the concept of Reliance Practices was included in the "Regulation on Variations in Licensed Medicinal Products for Human Use". With this positive development, reliance practices have found a place at the regulatory level for the first time. Throughout 2022, amendments to regulations and guidelines on reliance practices were published. TITCK started to receive variation applications within the scope of reliance practices for licensed products. These developments were also welcomed very positively by EFPIA and IFPMA.

The legislation and announcements published by TITCK within the scope of reliance practices are presented below:

PUBLICATION DATE

ISSUING AUTHORITY

LEGISLATION- ANNOUNCEMENT

10/06/2022

Drug Inspection Dept.

Regulation Amending the Regulation on Production Locations of Medicinal Products for Human Use

09/08/2022

Drug Inspection Dept.

Reliance Guideline for the Evaluation of Good Manufacturing Practices

02/09/2022

Clinical Research Dept.

Reliance Guideline for Clinical Trials Applications

09/09/2022

Dept. of Pharmacovigilance and Controlled Substances

Reliance Guideline for Pharmacovigilance Practices

25/09/2022

TITCK Department of Pharmaceutical Licensing

Regulation Amending the Regulation on Licensing of Medicial Products for Human Use

26/09/2022

TITCK Department of Pharmaceutical Licensing

Reliance Guideline fort he Licensing Process of Medicines for Human Use

12/10/2022

TITCK Department of Pharmaceutical Licensing

Communiqué on Application for Variations for Licensed Medicines for Human Use made within the concept of Reliance