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The harmonization of the regulatory framework for drugs and medical devices with EU legislation remains the key focus of Ukraine's pharma sector, according to Oleksiy Solovyov, Chairman of State Service of Ukraine on Drugs, who recently attended s conference on regulating drug and medical devices at the "PharmMedObraschenie 2013" exhibition, the Information-Analytical Bulletin of the Cabinet of Ministers of Ukraine informs.
Experts say over the past few years Ukraine has made a significant progress regarding the practical introduction of international pharmaceutical standards via two major international pharmaceutical standards: GMP – Good Manufacturing Practice and GPP – Good Pharmacy Practice.
Experts note that compliance with GMP has many differences from the current standard quality control procedure. While the old standard envisioned checking individual product items and definition of their compliance with accepted standards, compliance with new GMP standard demands meeting of high requirements for manufacturing process and laboratory testing. Also, since February 15, 2013, Ukraine has banned import of drugs not produced in compliance with GMP.
According to the State Drug Service, Ukraine was the first CIS state to introduce a mandatory requirement of GMP compliance in the course of production, while joining the Pharmaceutical Inspection Cooperation Scheme. In early 2014, Ukraine will start the gradual introduction of the European GPP standard.
Experts say Ukraine's pharmaceutical industry will need 0.5 to 1 billion USD for switching enterprises to international quality standards (GMP and GPP).
Results from the first half of 2013 show pharmacy sales of drugs in Ukraine reaching 14.6 billion UAH. Foreign produced drugs account for 34%, while domestically produced drugs make up the remaining 66%.