Co-operation with international partners
The EDQM places high value on its co-operation with a diverse range of international partners. The support of national pharmacopoeia authorities (NPAs), national competent authorities (NCAs), official medicines control laboratories (OMCLs), official cosmetics control laboratories (OCCLs), inspectorates and over 2 000 global experts in pharmaceutical sciences and practices, as well as specialists in healthcare issues such as blood transfusion, organ transplantation and quality of cosmetics and food contact materials, is indispensable for the success of its activities. Additionally, as an integral component of the European regulatory network, the EDQM meets and collaborates regularly with national regulatory authorities and the European Commission, as well as its technical agencies, such as the European Medicines Agency (EMA), the European Commission’s Joint Research Centre (JRC) and the European Food Safety Authority (EFSA).
Representatives of NCAs are also members of the European Pharmacopoeia Commission (EPC) and its expert groups (currently over 60) and working parties. In addition, NCAs also take part in the work of the European Pharmacopoeia (Ph. Eur.) by submitting requests for revision and reviewing draft texts published in Pharmeuropa online.
The 2023 annual meeting of NPAs took place in Helsinki (Finland) and was complemented by monthly meetings (see “The European Pharmacopoeia”).
The 28th General European OMCL Network (GEON) Annual General Meeting was held from 5 to 9 June 2023 in Madrid (Spain). Over 260 participants took part on-site, representing more than 60 OMCLs and affiliated institutions (see also “The European Network of Medicines Control Laboratories”).
Assessors and inspectors from NCAs contribute to the assessment of applications for Certificates of suitability (CEPs) and the associated inspection programme of active substance manufacturing sites. A meeting of all the assessors was held in hybrid format in October 2023. This was an opportunity to reinforce the network and discuss recent updates to the CEP procedure and the implementation of CEP 2.0.
NCAs, who also represent their member states in the eight Council of Europe intergovernmental committees (IGCs) co-ordinated by the EDQM, contributed to the elaboration of the deliverables of these committees in 2023 in the form of recommendations and resolutions adopted by the Committee of Ministers of the Council of Europe, or guidance documents.
The EDQM has observer status to the Heads of Medicines Agencies (HMA), the network of heads of the NCAs whose organisations are responsible for the regulation of medicinal products for human and veterinary use in the European Economic Area (EEA). In particular, the EDQM continued to work with the HMA Working Group of Enforcement Officers (HMA-WGEO) on the issue of falsified medicines. It attended the two working group meetings held, one involving OMCLs and the other, the Committee of Experts on Minimising the Public Health Risks posed by Falsified Medical Products and Related Crimes (CD-P-PH/CMED), where information was shared between health and law-enforcement authorities on cases involving the use of falsified medicines. The EDQM is also a member of the HMA Working Group of Quality Managers (WGQM) and maintains relations with the Non-Prescription Medicinal Products Task Force of the Co-ordination Group for Mutual Recognition and Decentralised Procedures-Human to explore convergence on the classification of medicines as regards their supply.
In the field of cosmetics, the EDQM regularly organises European market surveillance studies and takes part in open sessions of the EU Platform of European Market Surveillance Authorities for Cosmetics (PEMSAC).
Involvement in international harmonisation activities
Globalisation and expansion in international trade have created a growing need to develop global quality standards for medicines. The EDQM has been collaborating with sister pharmacopoeias to harmonise pharmacopoeial monographs for several decades. The most prominent example in this area is the Pharmacopoeial Discussion Group (PDG), jointly run historically with the United States Pharmacopeia (USP) and the Japanese Pharmacopoeia (JP), with the World Health Organization (WHO) and its International Pharmacopoeia as observers. The PDG welcomed the Indian Pharmacopoeia Commission as a fourth member in October 2023, further promoting global convergence in pharmacopoeial standards. The PDG is also actively working on updating the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q4B guideline and its annexes together with the ICH bodies. This work involves six further pharmacopoeias around the world and aims for harmonisation of 16 important pharmacopoeial general chapters.
In addition, the EDQM continues to play a crucial role in the WHO International Meeting of World Pharmacopoeias (IMWP) and works bilaterally with pharmacopoeias outside Europe. Prospective harmonisation activities currently under way with the USP, and more recently with the JP, should be highlighted.
The EDQM represents the Ph. Eur. within these initiatives. All the relevant groups of experts and working parties of the Ph. Eur. are involved (see also “The European Pharmacopoeia”).
Finding alternatives to the use of animals to test biological products is another international harmonisation activity in which the EDQM plays an important role. An example is the project led by the National Centre for the Replacement, Refinement & Reduction of Animals in Research (NC3Rs, UK) on behalf of WHO, with the aim of integrating the 3R principles (i.e. replacing, refining and reducing the use of animals in scientific research) into the guidelines published by the WHO Expert Committee on Biological Standardization (ECBS). The EDQM contributed to the NC3Rs working group and focus groups in order to promote the use of EDQM 3R achievements and ongoing 3R activities as a basis for further revisions of the WHO guidelines. EDQM staff and experts contributing to the work of the Biological Standardisation Programme and the Ph. Eur. also presented the highlights of the EDQM’s achievements and perspectives in this field at a workshop organised by the NC3Rs in London (UK) in September 2023.
The first phase of this initiative was completed with the publication of a comprehensive report submitted to the WHO ECBS in October 2023 (“Review of animal testing requirements in WHO guidelines and recommendations for biologics”).
In addition, as an observer to the ICH Assembly, the EDQM continues to play an active role in international harmonisation and collaboration activities. EDQM scientists actively participate in the development and revision of ICH guidelines that are important for the quality of medicines, including Q1, Q2/Q14, Q3C, Q3D, Q3E, Q4B, Q5A, Q9 and Q13, and also contribute to ICH discussion forums such as the Quality Discussion Group (QDG). The ICHQ5A(R2) guideline “Viral Safety evaluation of Biotechnology products from cell lines of human or animal origin” was adopted in November 2023.
The EDQM is actively engaged in the International Pharmaceutical Regulators Program (IPRP), where it co-chairs the Management Committee and plays an active role in the Quality Working Group and the Reliance discussion group. The EDQM hosted the meeting of the Quality Working Group and the Bioequivalence Working Group in May 2023. This meeting was followed by a workshop with industry stakeholders to share updates and expectations and to define the working groups’ workplans for the coming years.
The EDQM is also involved in the veterinary counterpart to the ICH, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Veterinary Use (VICH), and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) (see also “Certification of suitability to the Ph. Eur. monographs” and “Blood transfusion”).
All the activities in the eight IGCs co-ordinated by the EDQM address public health concerns and, more specifically, focus on access to and rational use of high quality and safe health products through the elaboration of standards, guidelines and sharing of best practices. To enhance harmonisation of practices in the field of pharmaceutical care, a summary report was published in 2023 on a survey run in 2022 involving seven countries of the South-eastern European Health Network (SEEHN), presenting data on the implementation of pharmaceutical care and related services in hospital and community care settings, as described in Resolution CM/Res(2020)3 on the implementation of pharmaceutical care for the benefit of patients and health services. The survey report was first presented at the 46th SEEHN Plenary Meeting and at a High-level Meeting on Strengthening the Healthcare Systems in South-Eastern Europe, held in Slovenia in December 2023. The purpose of the promotion and dissemination work ensured by the EDQM Secretariat is to monitor the implementation of the standards set by the IGCs and to assist member states in this task. This national level implementation is crucial if the standards are to have the expected positive impact on the availability and use of good quality medicines and healthcare in Europe.
The EDQM works with internationally recognised experts to regularly review and update common technical standards in the field of substances of human origin (SoHO). These include the Guide to the preparation, use and quality assurance of blood components (commonly referred to as the “Blood Guide”, 21st Edition, 2023) and Good Practice Guidelines for blood establishments (GPGs for BEs), the Guide to the quality and safety of organs for transplantation (the “Organ Guide”, 8th Edition, 2022) and the Guide to the quality and safety of tissues and cells for human application (the “Tissues and Cells Guide”, 5th Edition, 2022). The GPGs are now referenced in Commission Directive 2016/1214, ensuring that BEs in all EU/EEA member states take the standards and specifications set out in the GPGs into account when implementing their quality systems.
These reference works are internationally recognised as gold standards in the field.
In addition, to ensure consistency in approaches, the EDQM plays an active role in the work of the United Nations Office on Drugs and Crime (UNODC) with regard to the fight against organ trafficking.
Co-operation with the EU and the EMA
The EDQM works closely with the European Commission, communicating regularly to share progress reports on work programmes and potential developments in EU legislation. The Commission is a signatory party to the Convention on the Elaboration of a European Pharmacopoeia.
The EDQM is also a member of the European Union Network Data Board (EUNDB), set up in 2014 and co-chaired by the EMA and an NCA, and of the International Standards on Identification of Medicinal Products in the EU Task Force (EU ISO IDMP, created in 2015), including the corresponding subordinate groups.
It works closely with the EMA and national authorities to ensure that its activities (for example, the Ph. Eur. and Certification of suitability activities) remain consistent with the approaches of licensing authorities. It has observer status with a number of EMA bodies, including the Committee for Advanced Therapies (CAT), the Herbal Medicinal Products Committee (HMPC), the joint Committee for Medicinal Products for Human Use/Committee for Veterinary Medicinal Products (CHMP/CVMP) Quality Working Party (QWP), the Good Manufacturing and Distribution Practice Inspectors Working Group (GMDP IWG), the Biologics Working Party (BWP), the Immunologicals Working Party (IWP) and the 3Rs Working Party (3RsWP).
Likewise, the EMA is represented in many of the EDQM’s initiatives and bodies. Members of EMA working groups (for which the EMA provides the secretariat) or of the EMA Secretariat itself are observers to some of the EPC’s groups of experts and working parties, for example 6B (human blood and blood products), 15 and 15V (vaccines and sera for human use and veterinary use), and the Biologicals Standardisation Programme (BSP) Steering Committee.
As a member of the Certification Steering Committee, the EMA is an important partner in matters concerning the Certification procedure. Channels for regular communication are therefore in place for the elaboration of technical documents and for the inspection programme. The two bodies also collaborate on the long-established Centrally Authorised Product (CAP) Sampling and Testing Programme for products for human and veterinary use (see also “The European Network of Medicines Control Laboratories”).
Medicine shortages is another area in which the EDQM and the EMA exchange regularly. The EDQM is an observer to the EMA Medicines Shortages Single Point of Contact Working Party (SPOC WP), which will ensure the co-ordination of its work on shortages through the temporary use of stock pharmaceutical preparations with the EMA and the European Commission.
The long-standing close technical collaboration with the European Commission on SoHO activities continued in 2023. The EDQM co-ordinates the Blood Quality Management (B-QM) and Blood Proficiency Testing Scheme (B-PTS) Programmes, training sessions in the field of tissues and cells and B-QM, the projects on “Strengthening biovigilance programmes for organs, tissues and cells” and “Strengthening Deceased Circulatory Donation Programmes”, and performs the analysis of and reporting on EU SARE related to blood components and tissues and cells.
The EDQM continues to participate as an observer in meetings of the EU NCAs for blood, organs and tissues and cells. National authorities also take part, as steering committee members, in the work of the European Steering Committee on Blood Transfusion (CD-P-TS) and the European Steering Committee on Organ Transplantation (CD-P-TO). They contribute notably through the consultations on the Blood Guide, the Organ Guide and the Tissues and Cells Guide. As of 2023, EDQM representatives also participate in committees and meetings organised by the European Centre for Disease Prevention and Control (ECDC) in the field of SoHO. In addition, the EDQM actively participates in the EMA work cluster on blood products, thus ensuring consistent approaches are adopted.
On consumer health issues, the EDQM continues to participate as an observer in meetings of the EU Working Group on food contact materials (FCM), the EFSA FCM Network, the JRC Taskforce on kitchenware articles, and of the PEMSAC. In 2023, the EDQM submitted a position paper related to the ongoing revision of EU rules for food contact materials and articles. The JRC is a member of the ad hoc group on enamelled FCMs, which has been mandated to prepare technical guidance on the safety and quality of materials and articles intended for food contact. This work is co-ordinated by the EDQM.
Dialogue continued with the European Commission’s Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) in 2023, focusing on market surveillance of cosmetics and the contribution of the European Network of OCCLs, whose secretariat is ensured by the EDQM.
Co-operation on inspections
In 2023, the EDQM’s Certification Department continued its active involvement in the International API Inspection Programme and the Pharmaceutical Inspection Co-operation Scheme (PIC/S), including the Expert Circle on APIs. Since May 2023, the Certification Department has hosted the International API Inspection program secretariat.
The Organisation also participated in the 26th PIC/S Expert Circle meeting on Human Blood, Tissues and Cells, building upon the long-standing co-operation that ensures alignment between the GPGs of the Blood Guide and the “PIC/S GMP Guide for Blood Establishments”.
Co-operation with WHO
The EDQM co-operates extensively with WHO in a number of joint meetings and consultations. WHO is an observer to the EPC, while the EDQM:
- is an observer to the WHO Programme on International Nonproprietary Names (INNs);
- takes part in the WHO ECBS, with WHO participating as an observer in the meetings of the EDQM BSP Steering Committee, thus guaranteeing a smooth exchange of information;
- participates in the WHO Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP) (see also “Reference standards”);
- is a Coalition of Interested Parties (CIP) member since October 2022 and participated in the second WHO CIP Network Global Steering Group Meeting in November 2023;
- contributed to the WHO workshop on the implementation of international standards for quality control of polio vaccines organised in Jakarta (Indonesia) in November 2023;
- contributed to the General Meeting of the WHO Network of National Control Laboratories for Biologicals (WHO-NNB) organised in Bangkok (Thailand) in December 2023;
- shares data and carries out joint inspections relating to the API Certification process.
The EDQM is responsible for establishing, monitoring and distributing WHO International Standards for Antibiotics (ISAs) and International Chemical Reference Substances (ICRSs) (see “Reference standards” for more details).
In addition, the EDQM supports the organisation and implementation of the WHO External Quality Assurance Assessment Scheme (EQAAS) programme (currently EQAAS 11).
The EDQM also continued to contribute to the activities of the COVID-19 Vaccines Global Access (COVAX) Regulatory Advisory Group (RAG), in particular by providing expertise on the testing of COVID-19 vaccines, linked to its activities in the field of Official Control Authority Batch Release (OCABR) and quality assurance in vaccine manufacturing and testing. Until December 2023, the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi and WHO co-led COVAX, with the United Nations Children’s Fund (Unicef) as a key delivery partner, to ensure equitable access to COVID-19 vaccines.
The EDQM also collaborates with WHO in the fields of pharmaceuticals, pharmaceutical care, anti-falsification, blood transfusion and organ transplantation. In particular, in 2023 the EDQM contributed to a WHO training on Good Manufacturing Practices (GMP) for blood establishments in francophone countries by delivering online lectures.
Co-operation with manufacturers, industry associations and stakeholders
Stakeholders are invited to regular exchanges with the IGCs, and are consulted during the elaboration of standards. The consultation process takes place either within drafting groups, in which stakeholders are represented by experts in a given field, or through survey-based consultations of targeted stakeholders, such as patient, healthcare professional and donor associations.
The EDQM continues to hold annual bilateral meetings with a broad range of relevant industry associations to promote exchanges on all aspects related to the its scope of activities and to collect feedback.
