Chief Pharmaceutical Inspectorate

The 37th meeting of the Working Group of Enforcement Officers (WGEO) of the Heads of Medicines Agencies (HMA) organisation took place on 28-30 May 2025 in Warsaw, Poland. The meeting was attended by representatives of institutions responsible for pharmacovigilance, the prevention of medicines fraud and the international exchange of information between institutions in European countries. Experts from more than 50 institutions from countries in the area including the EU, EEA and Switzerland participated in the meeting.

WGEO meetings are an extremely important part of building pharmaceutical safety in Europe. The group involves the European Medicines Agency (EMA), the European Commission, the Council of Europe – EDQM, WHO, INTERPOL, Europol and the Pharmaceutical Security Institute. The Warsaw meeting was an opportunity to present the achievements of the Polish pharmaceutical inspectorate and to exchange experiences in detecting and preventing pharmaceutical crime. It was an excellent opportunity to exchange knowledge, experience and strengthen cooperation between foreign organisations, as well as important Polish institutions that uphold the safety of medicines for patients in Poland. The meeting was attended, among others, by experts from the Chief Pharmaceutical Inspectorate, POLADA and the Police, who shared Polish experience and successes in combating the phenomenon of counterfeit medicines.

Between 2021 and 2022, the Chief Pharmaceutical Inspectorate implemented project DWR/ADM2021/013/2 'Capacity building of the Georgian Medical and Pharmaceutical Regulatory Agency LEPL for the supervision of medicinal products', co-financed under the Polish development cooperation of the Ministry of Foreign Affairs of the Republic of Poland. The aim of the project was to harmonise the Beneficiary's pharmaceutical law with the standards applicable in the countries of the European Union. Due to the complexity of the topics, the project was divided into two modules.

Polish experts from the Chief Pharmaceutical Inspectorate and Voivodeship Pharmaceutical Inspectorates shared their knowledge of pharmaceutical law, administration and quality monitoring of medicinal products available on the national market with staff from the Georgian Agency for the Regulation of Medical and Pharmaceutical Activities LEPL. Discrepancies between the Georgian and European laws were analysed and recommendations were prepared regarding the changes that should be made to Georgia's pharmaceutical law in order to bring it in line with the requirements of the European market. The main areas of analysis consisted of the preparation and licensing of medicines, the monitoring of the quality of medicinal products available on the Georgian market, Rapid Alert (RA) procedures and the prevention of counterfeiting of medicinal products.

Polish experts prepared Georgian pharmaceutical inspectors on the practical side for inspecting the manufacturing conditions of medicinal products. Issues relating to drug law regulation were discussed in detail. Specialists from Georgia took part in a study visit to Poland, during which they had the opportunity to participate in demonstration inspections of pharmacies and wholesalers. They visited the factory of a Polish drug manufacturer, where they learnt about the proper preparation and conduct of inspections.

The above activities have professionally prepared Georgian specialists to supervise the market for medicinal products in Georgia in line with European standards. The knowledge they gained will help them build a strong, substantive and competent Agency to ensure that Georgian patients have access to safe, high-quality medicines.

Between 2021 and 2022, the Chief Pharmaceutical Inspectorate implemented online training courses within the framework of the DWR/ADM 2021/012/2 Polish development cooperation project, preparing the staff of the Armenian Scientific Centre for Drugs and Medical Technologies for the proper supervision of medicinal products. The aim of the project was to harmonise Armenia's pharmaceutical law with the standards applicable in the countries of the European Union. The project was divided into two modules.  During the implementation of Module I, experts from the Chief Pharmaceutical Inspectorate and Voivodeship Pharmaceutical Inspectorates shared their knowledge with the Beneficiary in the areas such as law, administration, principles of issuing permits for wholesale and retail trade in medicinal products, monitoring the quality of medicinal products available on the national market, the Rapid Alert procedure, the functioning of drug quality control laboratories and procedures for accession and functioning in international structures related to pharmacy.

In the following year of the Polish aid project, the Beneficiary acquired theoretical and practical knowledge of authorisation for the manufacture and import of medicinal products and registration in the register of manufacturers, importers and distributors of active substances. Experts presented aspects of pharmacy inspections, good manufacturing practice inspections of manufacturers and importers of medicinal products, pharmaceutical raw materials and active substances. The project attracted a lot of interest on the Armenian side. Its implementation allowed the Beneficiary to professionally prepare for the supervision of the market for medicinal products in Armenia in line with European standards. The acquired competences and training materials will constitute the introductory material for new and existing administrative staff and inspectors of the Armenian Inspectorate. Consistent levels of knowledge and competence among the professional staff will contribute to its stability and thus enhance the quality and effectiveness of the work carried out by the Beneficiary.

On November 26, 2019, the "Conference on fight against falsified medicinal products for human use" was organized by the Chief Pharmaceutical Inspector with the participation and funds of the European Commission. During the conference, foreign speakers representing the European Commission, the Ministry of Health in Portugal, Europol, the Council of Europe - EDQM, the Hungarian Institute for Health Insurance Funds Management, Health Action International and the Serbian Medicines Agency presented themselves. There were also speakers from Poland, representing: GIF, NIL, URPL, KAS and GIS. The issue of falsified medicinal products is extremely important in the context of ensuring the safety and health of patients in the country and in the world. The exchange of experience and expert knowledge allowed for a broader discussion of the issues in the context of the existing threats, methods of their elimination, the activities carried out to combat the presence of falsified medicinal products and the role of educational campaigns aimed at increasing public awareness.

In 2018, between 23 and 25 October, the Chief Pharmaceutical Inspector hosted the 24th meeting of the PIC/S Expert Circle “Human Blood, Tissues, Cells & ATMPs,” which was held in Warsaw. The undertaking was concerned with the current issues related to blood components as well as plasma and tissue derivatives, with an emphasis on advanced therapy medicinal products (ATMP). An international group of inspectors of nearly 100 people took part in workshops and lectures, visited the Polish Stem Cells Bank and the ATMP production facilities. The meeting was a perfect opportunity for the exchange of experience between inspectors who are responsible for controlling blood, tissue, and cell facilities as well as ATMP to improve the consistency of future audits.

In 2017, the Chief Pharmaceutical Inspector organised a workshop developed by experts from the Council of Europe – EDQM Workshop for Pharmaceutical inspectors in scope of falsified medicinal products. A counteroffer to organise the workshop was submitted by Great Britain, however, the Council of Europe gave priority to Poland. The possibility of organising such an event resulted from the involvement of a representative of the Chief of Pharmaceutical Inspectorate in the work of the Committee of Experts on Minimising Public Health Risks Posed by Falsification of Medical Products and Similar Crimes (CD-P-PH/CMED).

In 2016, our engagement in helping the Ukrainian administration resulted in another accepted application of the Ministry of International Affairs for a developmental collaboration project. This time, we focused on practical training for inspectors. Lectures organised as part of the project entitled In-depth capacity building of the Ukrainian pharmaceutical inspection caught much interest of the Ukrainian side. The interest was so high, that the training was also carried out online for participants from regional inspectorates.

In 2015, the Chief Pharmaceutical Inspectorate prepared an application for the execution of a developmental collaboration programme for Ukraine.  The Ministry of International Affairs gave positive opinion on the Chief Pharmaceutical Inspectorate’s application and granted us funds for the execution of the actions planned. The project Capacity building of State Administration of Ukraine on Medicinal Products (SAUMP) in the scope of supervision of manufacturing and distribution of medicinal products was carried out between July and December 2015 in Ukraine and Poland.  

In 2015, the Chief Pharmaceutical Inspectorate’s involvement in the twinning project in Kosovo resulted in an invitation to take part in the TAIEX project entitled Medium-term support to the Kosovo  Medicines Agency in setting up modern and effective pharmaceutical inspections carried out on pharmacies, wholesale companies, manufacturing and importers of medicines - Tasks 20168-9, TAIEX. Two experts of the Chief Pharmaceutical Inspectorate took part in the project involving cyclic training.  

In March 2014, again, we invited the participants of the PIC/S expert circle to Warsaw. This time, it was a meeting and training of the Good Distribution Practice Expert Circle. Between 25 and 27 March 2014, Poland hosted a group of around 80 GDP inspectors from all over the world.

In the second half of 2011, the Chief Pharmaceutical Inspector actively participated in the Polish Presidency in the Council of the European Union, organising one of the meetings as part of the HMA network. We organised the meeting of the Working Group of Enforcement Officers in collaboration with the Chief Veterinary Officer between 24 and 26 October 2011. Furthermore, the employees of the Chief Pharmaceutical Inspectorate participated in numerous international meetings organised at that time in Poland as national experts and speakers.

Between 2010 and 2012, chosen experts of the Chief Pharmaceutical Inspectorate had the opportunity of active participation in a twinning project organised by the German Federal Institute for Drugs and Medical Devices (Bfarm). In the project Capacity Building of the Kosovo Medicines Agency, the Chief Pharmaceutical Inspector was responsible for the execution of component 3. Pharmaceutical inspection and quality testing. We also invited experts from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products and Voivodeship Laboratories of Drug Quality Control to participate at the Polish side.  The invitation to participate was thanks to the very successful twinning project carried out by Germany for Poland as part of transitional measured in the years 2005-2006.

In September 2010, the Chief Pharmaceutical Inspectorate, hosted the participants of the PIC/S training in Poland again. This time, it was training for Good Manufacturing Practice Inspectors within the area of Quality Risk Management (QRM Training for GMP Inspectors). The training was held in Warsaw on 7-8 September 2010. It was the first training to be wholly recorded and given to the members of PIC/S.

In May 2008, the Chief Pharmaceutical Inspectorate hosted the participants of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) seminar. The subject matter of the seminar was Good Distribution Practice, which was not yet unified within the entire European Union at the time. The seminar entitled “Good Distribution Practice as one of the key elements for the quality assurance of medicinal products” was held on 28-30 May 2008 in Cracow. We hosted around 150 participants from all over the world.