{"id":291,"date":"2024-04-22T14:36:32","date_gmt":"2024-04-22T14:36:32","guid":{"rendered":"http:\/\/annualreport.edqm.eu\/?page_id=291"},"modified":"2024-06-10T14:51:15","modified_gmt":"2024-06-10T14:51:15","slug":"international-partners","status":"publish","type":"page","link":"https:\/\/annualreport2023.edqm.eu\/en\/international-partners\/","title":{"rendered":"International partners"},"content":{"rendered":"\t\t
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Co-operation with international partners<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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The EDQM places high value on its co-\u00adoperation 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\u2019s Joint Research Centre (JRC) and the European Food Safety Authority (EFSA).<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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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.\u00a0Eur.) by submitting requests for revision and reviewing draft texts published in Pharmeuropa<\/em> online.<\/p>

The 2023 annual meeting of NPAs took place in Helsinki (Finland) and was complemented by monthly meetings (see \u201cThe European Pharmacopoeia\u201d<\/a><\/span>).<\/p>

The 28th General European OMCL Network (GEON) Annual General Meeting was held from 5 to 9\u00a0June 2023 in Madrid (Spain). Over 260 participants took part on-site, representing more than 60 OMCLs and affiliated institutions (see also \u201cThe European Network of Medicines Control Laboratories\u201d<\/span><\/a>).<\/p>

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.<\/p>

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.<\/p>

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.<\/p>

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).<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Involvement in international harmonisation activities<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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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.<\/p>

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.<\/p>

The EDQM represents the Ph.\u00a0Eur. within these initiatives. All the relevant groups of experts and working parties of the Ph.\u00a0Eur. are involved (see also \u201cThe European Pharmacopoeia\u201d<\/span><\/a><\/span>).<\/p>

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.\u00a0Eur. also presented the highlights of the EDQM\u2019s achievements and perspectives in this field at a workshop organised by the NC3Rs in London (UK) in September 2023.<\/p>

The first phase of this initiative was completed with the publication of a comprehensive report submitted to the WHO ECBS in October 2023 (\u201cReview of animal testing requirements in WHO guidelines and recommendations for biologics<\/a><\/span><\/span>\u201d).<\/p>

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 \u201cViral Safety evaluation of Biotechnology products from cell lines of human or animal origin\u201d was adopted in November 2023.<\/p>

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\u2019 workplans for the coming years.<\/p>

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 \u201cCertification of suitability to the Ph.\u00a0Eur. monographs<\/a><\/span><\/span>\u201d and \u201cBlood transfusion<\/a><\/span><\/span>\u201d).<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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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<\/a><\/span>. 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.<\/p>

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<\/em><\/a><\/span><\/span>\u00a0(commonly referred to as the \u201cBlood Guide\u201d, 21st Edition, 2023) and Good Practice Guidelines for blood establishments (GPGs for BEs), the\u00a0Guide to the quality and safety of organs for transplantation<\/span><\/em><\/a><\/span>\u00a0(the \u201cOrgan Guide\u201d, 8th Edition, 2022) and the\u00a0Guide to the quality and safety of tissues and cells for human application<\/span><\/span><\/em><\/a>\u00a0(the \u201cTissues and Cells Guide\u201d, 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.<\/p>

These reference works are internationally recognised as gold standards in the field.<\/p>

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.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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