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Romeu, B., & Vazquez, J. E. (2022). Interrelation among Innovation, Medical Regulatory Agencies and Health Emergencies: Do We Need to Be Prepared for the Next Pandemic?. Revista Internacional De Cooperación Y Desarrollo, 9(1), 7–14. https://doi.org/10.21500/23825014.5967
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INTERNATIONAL JOURNAL OF COOPERATION AND DEVELOPMENT

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Abstract

Health regulation is often seen as a unilateral process only in charge of authorizing whether a medicine, a biological substance, equipment and/or medical device can be marketed or not. The current development of innovation, globalization, and health threats is forcing regulatory systems to face a changing environment. Integration into the new reality of the medicine market focuses on the need to adapt methodologies, which promote continuous and gradual learning within the regulatory process, as well as its capacity for strategic anticipation. This article shares some reflections on the importance of having an adaptive and planned mechanism for health emergencies, with periodic reviews and inserted in the automatic regulatory processes developed by each national regulatory agency. This aspect, seen as an integral part of the system, favors greater insertion of innovation, international regulatory collaboration, and convergence, by facilitating the regulatory agency's response to a pandemic and immediate access to safe health products. 

Keyword: Sanitary Regulation; Pandemic; Scientific Innovation; Medicines; International Cooperation; Health Emergency.

References

Nelson, C., Lurie, N., Wasserman, J. & Zakowski, S. (2007). Conceptualizing and defining public health emergency preparedness. Am J Public Health, 97(1), S9-S11. doi: 10.2105/AJPH.2007.114496
Pregelj, L., Hine, DC., Oyola-Lozada, MG. & Munro TP. (2020). Working hard or hardly working? Regulatory bottlenecks in developing a COVID-19 vaccine. Trends Biotechnol, 38, 943-7.
World Health Organization (WHO) (2017). A strategic framework for emergency preparedness. https://apps.who.int/iris/rest/bitstreams/1082021/retrieve
World Health Organization (WHO). (2020). IHR Procedures concerning public health emergencies of international concern (PHEIC). PHEIC Procedures. https://www.who.int/publications/m/item/covid-19-public-health-emergency-of-international-concern-(pheic)-global-research-and-innovation-forum
World Health Organization. (2005) International Health Regulations 3rd Edition [Internet]. Geneva, Switzerland; 2016. https://apps.who.int/iris/bitstream/handle/10665/246107/9789241580496-eng.pdf;jsessionid=571A416D79BA24BE767C1B1A23389728?sequence=1.
Lumpkin, MM. & Lim, JCW. (2020). Pandemic best regulatory practices: an urgent need in the Covid-19 pandemic. Clin Pharmacol Ther, 108(4), 703-705. https://doi.org/10.1002/cpt.1932
International Coalition of Medicines Regulatory Authorities, ICMRA. (2020). Statement on COVID-19. https://icmra.info/drupal/news/statement_on_COVID-19
Organización Panamericana de la Salud. (2020). Utilización de decisiones de otras autoridades regulatorias para autorizar el uso de emergencia de medicamentos y otras tecnologías sanitarias en una pandemia (por ejemplo, COVID-19). https://iris.paho.org/bitstream/handle/10665.2/52037/HSSMTCOVID19200006_spa.pdf?sequence=2&isAllowed=y
Food Drug Administration. (2 de mayo 2022). Autorización de uso de emergencia. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
European Medicines Agency (3 de mayo 2022). Conditional marketing authorization. https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/conditional-marketing-authorisation
Drugs Controller General of India (3 de enero 2021). Press Statement by the Drugs Controller General of India (DCGI) on Restricted Emergency approval of COVID-19 virus vaccine. https://www.icmr.gov.in/pdf/press_realease_files/HFW_DCGI_energency_use_authorisation_03012021_2.pdf
World Health Organization. (13 de diciembre de 2020). Emergency Use Listing Procedure. https://extranet.who.int/pqweb/sites/default/files/documents/EUL-FINAL-13_12_2020.pdf
World Health Organization. (2022a). Prequalification Procedures and Fees: FPPs, APIs & QCLs. Disponible en: https://extranet.who.int/pqweb/medicines/prequalification-procedures-and-fees
World Health Organization. (2022b) Accelerated Registration of FPPs Approved by SRAs. Disponible en: https://extranet.who.int/pqweb/medicines/faster-registration-fpps-approved-sras
Burki, T. (2019). Ebola virus vaccine receives prequalification. Lancet, 394(10212), 1893. doi: 10.1016/S0140-6736(19)32905-8. PMID: 31777382.
Siegenthaler, M. & Sietsema, W. (2016). Global Pharmaceutical & Biologics Regulatory Strategy. Regulatory Affairs Professionals Society ISBN 0996949151
Stewart, J., Honig, P., AlJuburi, L., Autor, D., Berger, S., Brady, P., Fitton, H., Garner, C., Garvin, M., Hukkelhoven, M., Kowalski, R., Milligan, S., O’Dowd, L., Reilly, E., Roberts, K., Robertson, A. S., Taisey, M., Thakkar, R., Van Baelen, K., & Wegner, M. (2021). COVID-19: A Catalyst to Accelerate Global Regulatory Transformation. Clinical pharmacology and therapeutics, 109(6), 1390-1392. https://doi.org/10.1002/cpt.2046
International Coalition of Medicines Regulatory Agencies, ICMRA. (24 de junio 2020). ICMRA statement on clinical trials. https://www.icmra.info/drupal/en/news/statement_on_clinical_trials

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