Chief Pharmaceutical Inspectorate

United Nations and its Agendas (UN, WHO, UNDOC)
The United Nations is an important partner of the Chief Pharmaceutical Inspectorate when it comes to two areas of collaboration.

Within the supervision over the trade in narcotics, psychotropic drugs, and category 1 precursors, the Office collaborates with:

• International Narcotics Control Board (INCB) responsible for the monitoring and supporting member states in the process of unifying the national approach to narcotics control treaties.
• Commission on Narcotic Drugs (CND) responsible for the analysis of the current global situation in terms of the access to narcotics and the help for the addicted.

 
When it comes to the problem of falsified medicines, the Chief Pharmaceutical Inspectorate engages in the works of the:

• Member State Mechanism on Substandard and Falsified Medical Products (MSM on SFMP), founded at the World Health Organisation, which is involved in the problem of falsified medical products (medicines, medical devices, supplements, cosmetics) on a global scale.  One of the recent successes of the Mechanisms is developing the definition of falsified medicines, which has been adopted by the General Assembly of WHO.

European Union (EC, EMA)
Within the European Union, the most important partner in terms of the execution of tasks related to the inspection of the manufacture and wholesale trade is the European Medicines Agency (EMA).
The Office participates in the legislative process at the EU level by taking part in working groups creating specific laws.

The experts of the Chief Pharmaceutical Inspectorates are invited to work within the following working groups:

• Pharmaceutical Committee – a committee coordinating matters related to medicinal products;
• Expert group meetings on the safety features: discussion on access to data in the repository systems – a group responsible for regulations implementing additional safety features of medicines in accordance with Directive 62/2011/EU;
• Access to medicines in Europe Working group – a group aimed at examining the phenomenon of medicines shortages within the European markets;
• Group of Experts on Drug Precursors – a group operating within the scope of legislation concerned with narcotic precursors;
• Experts Group on Clinical Trials – a group concerned with clinical trials of medicines (an expert from the Chief Pharmaceutical Inspectorate was involved in the meetings in the area of the inspection of products intended for trials);
• Working Party of Veterinary Experts – a group concerned with the regulations on the manufacture of veterinary products;

 
The Council of Europe (CoE, EDQM)
The most important partner of the Chief Pharmaceutical Inspectorate operating as part of the Council of Europe is the European Directorate of the Quality of Medicines and Healthcare (EDQM).
The employees of the Office on a regular basis participate in the meetings of the Committee and Subcommittees appointed as part of the Convention on the Elaboration of the European Pharmacopoeia:

• European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH) – the Committee has a superior, supervisory role over its subcommittees, it coordinates their works and verifies the results of their actions on an ongoing basis. It approves work plans and assesses their progress. The meetings of the Committee take place once a year in Strasbourg in the seat of the EDQM.
• Committee of Experts on quality and safety standards in pharmaceutical practice and pharmaceutical Care (CD-P-PH/PC) – the Committee is focused on ensuring unified standards of pharmaceutical care and pharmaceutical practice in the member countries of the Council of Europe. It engages external stakeholders in its works. The Committee is subject to CD-P-PH. The meetings are held twice a year in Strasbourg in the seat of the EDQM.
• Committee of Experts on Minimising Public Health Risks Posed by Falsification of Medical Products and Similar Crimes (CD-P-PH/CMED) – the basic task of the Committee is the coordination of measures aimed at promoting the MEDICRIME convention. Furthermore, it is responsible for educational programmes and communication in terms of threats posed by falsified medicinal products.                                                                                                                                                         

Pharmaceutical Inspection Co-operation Scheme (PIC/S)
PIC/S was founded in 1995 as a continuation of the Pharmaceutical Inspection Convention organised in 1970. The organisation operates as a non-binding, non-official agreement between authorities competent to carry out Good Manufacturing Practice inspections.  The fundamental objective of the organisation is harmonisation of inspection procedures in the world by unifying the Good Manufacturing Practice standards and providing inspectors with training in this area.

The organisation’s operations are based on the following bodies:

• PIC/S Management Committee – a managing committee composed of representatives of all the bodies that are members and observers of PIC/S. The committee makes decisions related to the functioning of the organisation. Some of the tasks are delegated to relevant substantive subcommittees;
• PIC/S Executive Board – management proper, composed of members of the Management Committee elected every two years;
• PIC/S Secretariat – a permanent secretariat of the organisation responsible for administrative tasks. It coordinates the collaboration between the members of the organisation.
• PIC/S subcommittees – responsible for individual substantive tasks of the organisation.

 
The employees of the Chief Pharmaceutical Inspectorate were or are members of the following subcommittees:

• PIC/S Sub-committee on GM(D)P Harmonisation – aimed at harmonising the regulations and guidelines concerned with Good Manufacturing Practice and Good Distribution Practice;
• PIC/S Sub-committee on compliance – which revolves around unifying inspection procedures in individual member countries;
• PIC/S Sub-committee on communication – responsible for internal communication among the members of the organisation, but also for promotion and external communication;
• PIC/S Sub-committee on strategic development – responsible for determining the directions of development and further works of the entire organisation.

 
What is more, the Chief Pharmaceutical Inspection is represented in numerous expert circles operating as part of PIC/S, such as:

• PIC/S Expert Circle on GDP – an expert circle organising training within Good Distribution Practice inspection;
• PIC/S Expert Circle on API – an expert circle focused on issues related to inspecting the active substance manufacture, distribution, and trade;
• PIC/S Expert Circle on Human Blood, Tissues , Cells & ATMPs – an expert circle within the field of inspecting the manufacture of human blood products, cell and tissue products, as well as advanced therapy medicinal products;
• PIC/S Expert Circle on Quality Risk Management – an expert circle within the field of medicinal product quality risk management;
• PIC/S Expert Circle on Computerised Systems – an expert circle within inspecting computer systems in the pharmaceutical industry.

 
Other
We take part in cyclic meetings organised by international organisations. Among others, every year, we participate in a meeting preparing for the PANGEA operation – an international week of actions aimed at counteracting falsified medicines on the Internet.
We also become involved in the operations of the Alliance for Safe Online Pharmacies, which in Europe is currently focused on promoting the common logo for online pharmacies.
We take part in cyclic Pharmacrime meetings organised by the International Institute of Research Against Counterfeit Medicines (IRACM).