On 1 January 2011, Ukraine, represented by the State Service of Ukraine on Medicines and Drugs Control, became a member of the Pharmaceutical Inspection Cooperation Scheme (PIC/S). This is an important step towards the integration of Ukrainian pharmacy into the global pharmaceutical community. With this step, Ukraine has committed itself to complying with international requirements for ensuring the safety, quality, and efficacy of medicines at all stages of their circulation.
The admission of the State Service of Ukraine on Medicines and Drugs Control to PIC/S is the recognition of the fact that legislation in the field of medicines circulation and the quality management system of the State Service of Ukraine on Medicines and Drugs Control meets the requirements established for PIC/S member countries, and that inspectors have the appropriate qualifications and experience to perform their duties.
PIC/S is an international instrument for cooperation between countries and regulatory authorities in the field of medicines quality control (national pharmaceutical inspectorates), which together ensure active and constructive cooperation in the field of good manufacturing practice (GMP), inspection, and licensing.
The purpose of PIC/S is to protect public health by:
- promoting and strengthening cooperation between PIC/S member authorities in the field of inspection of medicines manufacturing and related activities in order to maintain mutual confidence and encourage quality assurance of inspections;
- establishing a system for the voluntary exchange of information and experience;
- coordinating mutual training of inspectors;
- improving and harmonizing technical standards and procedures for the inspection of medicines manufacturing and testing by officially certified laboratories;
- development, harmonization, and use of Good Manufacturing Practice;
- extension of cooperation to other competent authorities whose national legislation allows for the application of equivalent standards and procedures with an aim to achieve global harmonization.
PIC/S member regulatory authorities constantly exchange information on standards for the manufacture and distribution of medicines, licensing and inspection procedures, and provide ongoing training for inspectors, which in turn allows them to maintain state control over the medicines quality at the appropriate level, taking into account international best practices.
PIC/S documents
The list of documents governing PIC/S is available on the official PIC/S website (https://www.picscheme.org).
PIC/S member countries
A PIC/S member country is a country that has an authorized body in the field of  medicines quality control, which is a member of the international Pharmaceutical Inspection Cooperation Scheme (PIC/S).
Currently, PIC/S has 56 regulatory member authorities from EU/EEA countries such as Germany, Italy, Ireland, France, Switzerland, Poland, the USA, Argentina, Australia, Canada, Israel, Malaysia, Singapore, and South Africa. Japan and South Korea are scheduled to join PIC/S on 1 July 2014. The list of PIC/S member regulatory authorities is available on the official PIC/S website (https://www.picscheme.org).
PIC/S partners include such authoritative international organizations as:
- World Health Organization
- European Directorate for the Quality of Medicines and Healthcare
- European Medicines Agency
- United Nations International Children’s Emergency Fund (UNICEF).