19-20 May 2010 in Geneva a meeting of the Executive Committee of the PIC / S was held. The Ukrainian delegation, headed by Alexei Soloviev, Chairman of the State Inspectorate for Quality Control of Drugs Ministry of Ukraine, Chief State Inspector of Ukraine for Quality Control of Drugs.
Pharmaceutical Inspection Cooperation System – PIC / S – an international agreement between national regulatory authorities in the field of drug quality control, design and implementation of standards of Good Manufacturing Practice (GMP).
In 2003, Ukraine has declared its intention to join to the PIC / S by applying for membership. Formal declaration of membership to the PIC / S is represented by the Ukrainian side 01.11.2004. State Inspectorate for Quality Control of Drugs of the Healthcare Ministry (hereinafter – Inspection) was established according to the decree, the Cabinet of Ministers of 17.03.2010 № 275 “Some problems of state control of quality medicines.”
According to the official invitation representatives of the Ukrainian regulatory authority in the field of drug quality control 6 times attended meetings of the Executive Committee of the PIC / S since 2005 and actively participated in seminars conducted by PIC / S in order to implement European standards in the drug market and the harmonization of Ukrainian legislation with international norms. The Committee of PIC / S are 2 times a year. Last held 19-20 May 2010 in Geneva, where are situated the headquarters of this international organization.
The meeting was attended by representatives of 37 organizations from PIC / S and representatives of regulatory authorities of the countries now on track for membership in this organization, in particular Inspection of MH of Ukraine and the Office for the Control of Food and Drug Administration USA (Food and Drug Administration – FDA).
According to regulations of the meeting were discussed issues of entry into PIC / S candidate countries – Ukraine and the USA. By FDA by the Executive Committee of PIC / S identified the need to finalize the legislative instruments in the field of quality control of medicines regulatory agency of the United States to purchase the equivalent requirements of the PIC / S system.
Also a report by the Audit Ukrainian regulatory authority in the field of quality control of medicines (22-26 March 2010) was presented by Ann Hayes (Ireland) – one of the curators of Ukraine’s membership in PIC / S.
The main and essential term for Ukraine’s joining PIC / S is the harmonization of Ukrainian legislation in the sphere of the drug with the European requirements. And even after the entry into PIC / S Ukraine, like all other members of the organization, must continually make changes to existing legislation in line with new requirements, which will be gradually introduced to the international regulations.
At the end of the meeting, the Executive Committee of the PIC / S had decided to conduct another audit of Inspection of MOH. The staff of the inspection team will be unchanged. In the audit team included the curator Ann Hayes (Ireland / IMB), curator Zofiyu Ults (Poland / MPI), Luisa Stoppa (Italy / AIFA) and Michelle Keller (Switzerland / Swissmedic). Audit scheduled for September 2010. Its main goal – to verify compliance activities to address the inconsistencies identified in the previous audit and inspection of state laboratories for quality control of medicines, which were not subject to the prior audit. Inspection’s specialists will make every effort to make this audit was the last, and make the appropriate changes in domestic regulations.
During the meeting, committee members noted that in Ukraine there is no procedure for licensing of companies importing drugs. This procedure is obligatory in the EU. Representatives of the Ukrainian delegation explained that the regulatory framework in the control of import of medicines of Ukraine on the effectiveness of the equivalent European standards.
As a result Inspection of MOH received a positive assessment of the Executive Committee of the PIC / S, has been considerable progress in the functioning of the quality system of Inspection and in improving the existing legislation of Ukraine in the sphere of the drug for its harmonization with EU legislation.
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