International collaboration - Chief Pharmaceutical Inspectorate

From the beginning it was clear that we are part of Europe and we want to be an active member of the European Union. Full involvement of Polish inspections at all ventures fields of market surveillance of medicinal products in the international arena has always been one of the priorities of the Chief Pharmaceutical Inspectorate work. Since 2001 employees CPI have taken an active part in the EU PHARE Projects in the field of combating drug-related crime and reduction of drug demand.

At the same time, work began on the key element to our credibility as pharmaceutical inspection, a full membership in the structure of the Pharmaceutical Inspection Co-operation Scheme - PIC / S.

First of all we need to adjust the inspections quality system to worldwide standards so that our inspections were considered equivalent to the inspections of all other PIC / S Participating Authorities. CPI joined PIC/S in January 2006. Since then, we are an active member and CPI employees are actively involved in numerous Working Groups and Expert Circles at the PIC / S. It should be underlined that, despite our relatively short membership (PIC / S and PIC has been operating since 1972) we organized two important events:

The first is an annual PIC/S Seminar that took place in May 2008 in Cracow. PIC/S Seminars are held once a year, each time hosted by other PIC/S Participating Authority - so another opportunity for Poland is expected within 16 years and taking into account that the organization is constantly growing and accepting new members, it could be even later.

The second event was the first training for inspectors in the field the Quality Risk Management - QRM, scheduled for April 2010 was held in September 2010. Unfortunately, the volcanic eruption in Iceland thwarted our preliminary plan few days before the scheduled date in April.

Between 2004-2006 MPI worked on the Twinning Project - Medicinal Products for Human Use. Several EU countries answered on our offer of cooperation, the final confrontation invited the Spaniards and Germans, we chose our western neighbors.

On 25 October 2005 after we negotiated the Twinning Contract, an intensive period of one year training for employees of the State Pharmaceutical Inspection in four previously considered priority topics began. The key issues were:

• Polish law adjustment to the EU standards  
• GMP Inspection
• Medicines market surveillance and pharmacovigilance
• Advertising of medicines / borderline products

Trainings were attended by 771 people representing all 16 provincial pharmaceutical inspectorates and 9 medicines quality control laboratories. We had a series of experts meetings. We have prepared hundreds of documents, which are still partly used in our daily work. The above does not exhaust the issue of international cooperation - we still wanted more. The next step we took was the approval of our inspections under the Mutual Recognition Agreement (MRA). of inspection Intensive work on the improvement of our inspection quality system in order to ensure the equivalence of inspections carried out by our GMP inspectors.

The road was difficult, exchange of documents and preliminary assessment of the quality system took couple of years to eventually end up in 2010 with 4-week audit of the Canadian auditor in Poland. Positive decision was issued in August 2011, and since that time our inspections are recognized by MRA partners such as Australia, Canada, New Zealand, Switzerland and Japan (so called third countries).

Inspection next step was to underline of our presence on the international arena not only as a member but also as an active participant, ready to work. We had a fresh perspective and experience, and a great desire to help. We were involved in two European projects:

• First was assessment of the Ukrainian Medicines Agency before its access to the PIC/S. Not only we assessed the documents and work of Ukrainian Inspection, we have also helped by organizing training and study visit in the Chief Pharmaceutical Inspectorate. Ukraine's road to the PIC/S was a success, from 1 January 2011 the meet at organization's forum
• Second project was the participation of representatives of the State Pharmaceutical Inspection in the Twinning Project - Support to the Health Sector - Capacity Building of the Kosovo Medicines Agency, carried out by the German Office for Registration of Medicinal Products (BfArM). The project started in October 2010 and from the first activity Polish experts were invited for experts meetings and trainings to Kosovo.

Currently the Chief Pharmaceuticals Inspectorate’s international cooperation is developing in two basic forms – bilateral and multilateral.

• Bilateral cooperation is mainly information exchange with national pharmaceutical inspection bodies worldwide, covering all matters lying within the competencies of the Chief Pharmaceutical Inspectorate.
• In the multilateral forum, the Chief Pharmaceutical Inspectorate participates in the work of committees, numerous working groups and expert circles which function within international organizations – those which gather together pharmaceutical inspection bodies and also others whose competencies include broadly-defined issues related to oversight of the medicinal products market and supervision of medicinal products for humans and animals, including:
  • World Health Organization (WHO)
  • European Commission (EC)
  • Council of Europe (CoE)
  • European Medicines Agency (EMA)
  • Heads of Medicines Agencies (HMA)
  • Pharmaceutical Inspection Cooperation Scheme (PIC/S)
  • European Directorate for the Quality of Medicines & HealthCare (EDQM)
  • Mutual Recognition Agreement (MRA)
  • United Nations International Narcotic Control Board (UN INCB)
  • Working Group of Enforcement Officers (WGEO)
  • International Medical Products Anti-Counterfeiting Taskforce (IMPACT)