Belarus to join pharmaceutical inspection cooperation scheme

Belarus intends to join the Pharmaceutical Inspection Cooperation Scheme (PIC/S), BelTA learned from representatives of the Belarusian Healthcare Ministry as they commented on Council of Ministers executive order No. 831 of 27 August 2014.

The executive order authorizes the accession of the Belarusian Healthcare Ministry to the Pharmaceutical Inspection Cooperation Scheme. The expenses involved in joining PIC/S and being a member will be covered by the portion of the central state budget allocated for international activities of the Healthcare Ministry.

The source explained that the Ministry and PIC/S had signed an agreement on preliminary accession as a candidate. A cooperation plan is now available as well as a roadmap, plans have been made for sharing information and for jointly inspecting Belarusian manufacturers to verify their compliance with good manufacturing practices of the European Union.

Compliance of Belarusian manufacturers with GMP requirements is needed for the sake of bolstering the export potential of Belarusian manufacturers of medications. Competence during control and supervision procedures is also important. Stronger cooperation with PIC/S will help achieve these goals and will also allow taking part in joint inspections in addition to training the specialists that oversee manufacturing and sales of medications, said representatives of the Belarusian Healthcare Ministry. On the whole, the work is aimed at regulating manufacturing practices, raising the quality of Belarusian products, recognizing results of production and inspection at an international level.

PIC/S is a respected non-governmental organization that promotes international cooperation in this area. The organization focuses on implementing GMP standards in quality control of medical products. The organization comprises over 40 countries, including Germany, the UK, France, the USA, Japan, Australia, and Brazil. Cooperation with PIC/S is the most effective way to get up-to-date regulatory documents and European Union recommendations that regulate the modern production and quality control of medications, noted the source.