Centre for Pharmaceutical Policy and Regulation

2025

Effectiveness of COVID-19 vaccines against SARS-CoV-2 infection and severe outcomes in adults: a systematic review and meta-analysis of European studies published up to 22 January 2024

Zhou, G., Dael, N., Verweij, S., Balafas, S., Mubarik, S., Rengerink, K. O., Pasmooij, A. M. G., van Baarle, D., Mol, P. G. M., de Bock, G. H. & Hak, E., Jan 2025, In: European Respiratory Review. 34, 175, 17 p., 240222.

Research output: Contribution to journal › Review article › peer-review

Open Access

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The state-of-the-art of N-of-1 therapies and the IRDiRC N-of-1 development roadmap

on behalf of The N-of-1 Task Force of the International Rare Diseases Research Consortium (IRDiRC), Jonker, A. H., Tataru, E. A., Graessner, H., Dimmock, D., Jaffe, A., Baynam, G., Davies, J., Mitkus, S., Iliach, O., Horgan, R., Augustine, E. F., Bateman-House, A., Pasmooij, A. M. G., Yu, T., Synofzik, M., Douville, J., Lapteva, L., Brooks, P. J. & O’Connor, D. & 1 others, Aartsma-Rus, A., 2025, In: Nature Reviews Drug Discovery. 24, 1, p. 40-56 17 p., e10486.

Research output: Contribution to journal › Review article › peer-review

2024

A literature review of quality assessment and applicability to HTA of risk prediction models of coronary heart disease in patients with diabetes

Jiu, L., Wang, J., Javier Somolinos-Simón, F., Tapia-Galisteo, J., García-Sáez, G., Hernando, M., Li, X., Vreman, R. A., Mantel-Teeuwisse, A. K. & Goettsch, W. G., Mar 2024, In: Diabetes Research and Clinical Practice. 209, 10 p., 111574.

Research output: Contribution to journal › Review article › peer-review

Open Access

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Environmental risk assessment in the EU regulation of medicines for human use: an analysis of stakeholder perspectives on its current and future role

Zinken, J. F., Pasmooij, A. M. G., Ederveen, A. G. H., Hoekman, J. & Bloem, L. T., Dec 2024, In: Drug Discovery Today. 29, 12, 16 p., 104213.

Research output: Contribution to journal › Review article › peer-review

Open Access

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Epidemiological surveillance of drug safety using cumulative sequential analysis in electronic healthcare data

Aakjær, M., De Bruin, M. L. & Andersen, M., Jan 2024, In: Basic and Clinical Pharmacology and Toxicology. 134, 1, p. 129-140 12 p.

Research output: Contribution to journal › Review article › peer-review

Open Access

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Healthcare decision-making for tumour-agnostic therapies in Europe: lessons learned

Hogervorst, M. A., van Hattem, C. C., Sonke, G. S., Mantel-Teeuwisse, A. K., Goettsch, W. G. & Bloem, L. T., Jul 2024, In: Drug Discovery Today. 29, 7, 104031.

Research output: Contribution to journal › Review article › peer-review

Open Access

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Lifecycle HTA: Promising applications and a framework for implementation

Pichler, F. B., Boysen, M., Mittmann, N., Gilardino, R., Bruce, A., Bond, K., Vreman, R. A., Largeron, N., Banhazi, J., Ollendorf, D. A., Jain, M., Upadhyaya, S. & Goettsch, W. G., Oct 2024, In: International Journal of Technology Assessment in Health Care. 40, 1, 25 p., e50.

Research output: Contribution to journal › Review article › peer-review

Open Access

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The Evolution of Drug Regulatory Sciences in the Netherlands: More than a Country Report

Pasmooij, A. M. G., Mol, P. G. M., Bot, J. C. & Leufkens, H. G. M., Jul 2024, In: Clinical Pharmacology and Therapeutics. 116, 1, p. 64-71 8 p.

Research output: Contribution to journal › Review article › peer-review

Open Access

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2023

Barriers to accessing internationally controlled essential medicines in sub-saharan Africa: A scoping review

Ooms, G. I., van Oirschot, J., de Kant, D., van den Ham, H. A., Mantel-Teeuwisse, A. K. & Reed, T., Aug 2023, In: International Journal of Drug Policy. 118, 104078.

Research output: Contribution to journal › Review article › peer-review

Open Access

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Evidence on the effectiveness of policies promoting price transparency -: A systematic review

Joosse, I. R., Tordrup, D., Glanville, J., Kotas, E., Mantel-Teeuwisse, A. K. & van den Ham, H. A., Aug 2023, In: Health Policy. 134, 8 p., 104681.

Research output: Contribution to journal › Review article › peer-review

Open Access

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How to Price and to Reimburse Publicly Funded Medicines in Latin America? Lessons Learned from Europe

Leopold, C., Poblete, S. & Vogler, S., Dec 2023, In: Medicolegal news. 51, S1, p. 76-91 16 p.

Research output: Contribution to journal › Review article › peer-review

Reimbursement and payment models in Central and Eastern European as well as Middle Eastern countries: A survey of their current use and future outlook

Callenbach, M. H. E., Ádám, L., Vreman, R. A., Németh, B., Kaló, Z. & Goettsch, W. G., 1 Jan 2023, In: Drug Discovery Today. 28, 1, p. 1-9 9 p., 103433.

Research output: Contribution to journal › Review article › peer-review

Open Access

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2022

Building HTA insights into the drug development plan: Current approaches to seeking early scientific advice from HTA agencies

Wang, T., McAuslane, N., Gardarsdottir, H., Goettsch, W. G. & Leufkens, H. G. M., Jan 2022, In: Drug Discovery Today. 27, 1, p. 347-353 7 p.

Research output: Contribution to journal › Review article › peer-review

Open Access

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CODE-EHR best-practice framework for the use of structured electronic health-care records in clinical research

Innovative Medicines Initiative BigData@Heart Consortium, European Society of Cardiology, and CODE-EHR International Consensus Group, 1 Oct 2022, In: The Lancet Digital Health. 4, 10, p. E757-E764 8 p.

Research output: Contribution to journal › Review article › peer-review

Open Access

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Emergent treatments for β-thalassemia and orphan drug legislations

Costa, E., Cappellini, M. D., Rivella, S., Chilin, A., Alessi, E., Riccaboni, M., Leufkens, H. G. M. & Luzzatto, L., Nov 2022, In: Drug Discovery Today. 27, 11, p. 1-13 13 p., 103342.

Research output: Contribution to journal › Review article › peer-review

Open Access

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Four scenarios for the future of medicines and social policy in 2030

Leufkens, H. G., Kusynová, Z., Aitken, M., Hoekman, J., Stolk, P., Klein, K. & Mantel-Teeuwisse, A. K., Aug 2022, In: Drug Discovery Today. 27, 8, p. 2252-2260 9 p.

Research output: Contribution to journal › Review article › peer-review

Open Access

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Nature and timing of post-approval manufacturing changes of tumour necrosis factor α inhibitor products: A 20-year follow-up study of originators and biosimilars

Alsamil, A. M., Giezen, T. J., Egberts, T. C., Doevendans, E., Leufkens, H. G. & Gardarsdottir, H., 1 Aug 2022, In: European Journal of Pharmaceutical Sciences. 175, p. 1-8 8 p., 106227.

Research output: Contribution to journal › Review article › peer-review

Open Access

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2021

A Systematic Review of Collective Evidences Investigating the Effect of Diabetes Monitoring Systems and Their Application in Health Care

Kamusheva, M., Tachkov, K., Dimitrova, M., Mitkova, Z., García-Sáez, G., Hernando, M. E., Goettsch, W. & Petrova, G., 16 Mar 2021, In: Frontiers in Endocrinology. 12, p. 1-23 23 p., 636959.

Research output: Contribution to journal › Review article › peer-review

Open Access

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2020

Cancer is associated with severe disease in COVID-19 patients: a systematic review and meta-analysis

Ofori-Asenso, R., Ogundipe, O., Agyeman, A. A., Chin, K. L., Mazidi, M., Ademi, Z., de Bruin, M. L. & Liew, D., 18 May 2020, In: ecancermedicalscience. 14, 10 p., 1047.

Research output: Contribution to journal › Review article › peer-review

Open Access

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Improving Interactions Between Health Technology Assessment Bodies and Regulatory Agencies: A Systematic Review and Cross-Sectional Survey on Processes, Progress, Outcomes, and Challenges

Ofori-Asenso, R., Hallgreen, C. E. & De Bruin, M. L., 16 Oct 2020, In: Frontiers in Medicine. 7, 17 p., 582634.

Research output: Contribution to journal › Review article › peer-review

Open Access

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Reporting of quality attributes in scientific publications presenting biosimilarity assessments of (intended) biosimilars: a systematic literature review

Alsamil, A. M., Giezen, T. J., Egberts, T. C., Leufkens, H. G., Vulto, A. G., van der Plas, M. R. & Gardarsdottir, H., 1 Nov 2020, In: European Journal of Pharmaceutical Sciences. 154, 105501.

Research output: Contribution to journal › Review article › peer-review

Open Access

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Systematic reviews of ten pharmaceutical pricing policies - A research protocol

Tordrup, D., Van Den Ham, H. A., Glanville, J. & Mantel-Teeuwisse, A. K., 16 Jul 2020, In: Journal of Pharmaceutical Policy and Practice. 13, 1, 7 p., 22.

Research output: Contribution to journal › Review article › peer-review

Open Access

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2019

The effectiveness of direct to healthcare professional communication: A systematic review of communication factor studies

Møllebæk, M., Kaae, S., De Bruin, M. L., Callréus, T., Jossan, S. & Hallgreen, C. E., May 2019, In: Research in Social and Administrative Pharmacy. 15, 5, p. 475-482 8 p.

Research output: Contribution to journal › Review article › peer-review

Open Access

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2018

Expanding global access to essential medicines: investment priorities for sustainably strengthening medical product regulatory systems

Roth, L., Bempong, D., Babigumira, J. B., Banoo, S., Cooke, E., Jeffreys, D., Kasonde, L., Leufkens, H. G. M., Lim, J. C. W., Lumpkin, M., Mahlangu, G., Peeling, R. W., Rees, H., Ndomondo-Sigonda, M., Stergachis, A., Ward, M. & Nwokike, J., 1 Nov 2018, In: Globalization and Health. 14, 1, 102.

Research output: Contribution to journal › Review article › peer-review

Open Access

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