Practical implementation of the PIC/S principles in Ukraine after its accepting international requirements for quality control of medicinal products

Abstract

Pharmaceutical Inspection Cooperation Scheme (PIC/S) is an international instrument of interaction between countries and regulatory authorities in the sphere of quality control of medicines (by national pharmaceutical inspectorates), which together provide an active and constructive cooperation in the field of good manufacturing practices (GMP), inspection and licensing. Aim. To develop a strategy, tactics and sequence of applying adaptation mechanisms to the pharmaceutical industry legislation of Ukraine according to EU and the PIC/S requirements. Results. In 2010, within Ukraine joining to the PIC/S the starting audit of researches on adaptation of medicinal products quality standards to the international requirements was carried out. In the period from March 22 to 26, 2010 the PIC/S audit team performed the final audit in order to check the readiness of Ukraine to join the PIC/S. On November 8,2010 a decision on Ukraine’s membership was made in Kuala Lumpur (Malaysia). Since January1, 2011 Ukraine has become the PIC/S member within the system of medicinal products circulation and quality control in accordance with GMP/GDP and EU Directive 2001/83/EC. During the period of Ukraine’s accession to the PIC/S system, accordingly, this Directive was improved. At the VIII National pharmaceutical Congress (Kharkiv, September 14-16, 2016) 26 additions to the decision of Congress were proposed, including questions related to the PIC/S and other legislative initiatives. Conclusions. Legislative documents of the system of medicines quality control and circulation inspection are the international requirements of the PIC/S. The principles, measures and requirements were developed, discussed and accepted that contributed to the accession of Ukraine to the PIC/S system in 2011.