State Service of Ukraine on Medicines and Drugs Control in the Working Group on PIC/S Inspection Reliance
Опубліковано 20.11.2020 о 13:47In July 2018 the PIC/S adopted the guidance «GMP Inspection Reliance» PIC/S PI 048-1 which contains recommendations regarding development and implementation of the procedure for GMP correspondence while remote inspection.
In October 2020 the Working Group on PIC/S Inspection Reliance was formed to develop and adopt the guidance «GMP Inspection Reliance» and define related risks related to the influence made by the spread of coronavirus disease COVID-19.
Representatives of such regulatory authorities (PIC/S members) as Australia/TGA Switzerland /Swissmedic, Great Britain /MRHA, Ukraine / SMDC and EMA became members of the Working Group.
18 November 2020 the first meeting of the Working Group on PIC/S Inspection Reliance was held online.
The Director of the Department of Production Licensing, Importation of Medicines, Control over Compliance with Licensing Conditions and Certification of the State Service of Ukraine on Medicines and Drugs Control and the Head pf Quality System Management Sector of the State Service of Ukraine on Medicines and Drugs Control became members of the Working Group and took part on behalf of Ukraine.
Currently Ukraine is one of the first PIC/S countries that have procedure adopted by legislation and has been in force for more than 10 years. This experience is rather useful to be shared with other countries.