Implementing and improving quality control tests for human vaccines and sera

Implementing and improving quality control tests for human vaccines and sera

Transition Assistance and Institution Building

Background

Turkey’s requirement to harmonise its laws with those of the EU for the free movement of goods also covers the field of medical products. The Ministry of Health is chiefly responsible in this area, with the Turkish Medicines and Medical Devices Authority (TİTCK) authorised to conduct the safety and efficacy tests required by the relevant EU legislation. The agency’s Biological Control and Research Laboratory required training, assistance and additional equipment to enhance its vaccine testing capacity and to standardise its test methods for vaccines and sera.

The aims of the project and its core activities

The project aims to enhance the access of Turkish citizens to safe and effective vaccine and sera in line with the EU standards and to facilitate the trading process of such products in an efficient manner.

Each year, Turkey imports about 35 million doses of vaccines, which are subject to quality control tests. About 79% of vaccines in the world are produced in Europe and 91% of the doses produced are exported, contributing to public health around the globe. Such products are tested by the authorities prior to entering the market and batch releases are granted according to test results. The project is helping Turkey to establish a better testing capacity and to bring the public laboratory in charge of quality controls, namely, the Biological Research and Control Laboratory operating under the Turkish Medicine and Medical Devices Agency, to the status of an EU Official Medicines Control Laboratory (OMCL).

The project consists of two components: supply and twinning. The supply component of the project involved acquiring new equipment for the laboratory to enable it perform its duties more efficiently.

The twinning component, conducted with the Italian National Institute of Health and the Bulgarian National Centre for Infectious and Parasitic Diseases, involves transfer of know-how through several theoretical and practical trainings and study visits on test methods and quality control tests of vaccines and sera.