Correo Electrónico
DNINFOA - SIA
Bibliotecas
Convocatorias
Identidad U.N.
Publicado
Inteligencia Regulatoria en la gestión de los productos biofarmacéuticos: su aplicabilidad para el sector biotecnológico cubano
Regulatory intelligence for the management of biopharmaceutical products: applicability for the Cuban biotech sector
Inteligência Regulatória na gestão dos produtos biofarmacêuticos: sua aplicabilidade para o setor biotecnológico cubano
Palabras clave:
inteligencia regulatoria, estrategia regulatoria, industria biofarmacéutica, agencia reguladora (es)regulatory intelligence, regulatory strategy, biopharmaceutical industry, regulatory agency (en)
inteligência regulatória, estratégia regulatória, indústria biofarmacêutica, agência reguladora (pt)
Descargas
Introducción: La industria biofarmacéutica en la actualidad ha dirigido sus programas de desarrollo de productos hacia enfoques más complejos y de mayor valor agregado, lo cual conlleva un gran riesgo asociado en su camino hacia el registro sanitario. Sin embargo, la predictibilidad de estos procesos se complejiza aún más en gran medida por la necesidad de gestionar de forma acertada estos riesgos y los grandes volúmenes de datos e información a manejar. Las compañías farmacéuticas deben adecuar sus procesos de forma que contribuyan a construir un puente entre la excelencia científica de las investigaciones y el conocimiento de los requerimientos para proceder de manera exitosa en el desarrollo de un producto biofarmacéutico. Metodología: El presente trabajo aborda la relación única y coherente que conforma el proceso de Inteligencia Regulatoria. Su aplicabilidad de forma proactiva en el sector biotecnológico cubano potenciaría el monitoreo adecuado de un entorno regulatorio cambiante acentuado por la nueva normalidad debido a la COVID-19. Resultados: La evolución del panorama regulatorio acentúa la necesidad de contar con información actualizada e interpretar la orientación de los expertos en asuntos regulatorios conduciendo a mejores decisiones, menos demoras y aprobaciones más oportunas de nuevas opciones de productos sanitarios para los pacientes.
Introduction: The biopharmaceutical industry has currently directed its product development programs towards more complex and higher value-added approaches, which entails a great associated risk on its way to marketing authorization. However, the predictability of these processes is made even more complex by the need to correctly manage these risks and the large volumes of data and information to be handled. Pharmaceutical companies must adapt their processes in such a way that they contribute to building a bridge between the scientific excellence of research and the knowledge of the requirements to proceed successfully in the development of a biopharmaceutical product. Methodology: This work addresses the unique and consistent relationship that makes up the Regulatory Intelligence process. Its proactive applicability in the Cuban biotechnology sector would enhance the adequate monitoring of a changing regulatory environment accentuated by the new normality due to COVID-19. Results: The evolution of the regulatory landscape fuels the need to have up-to-date information and interpret the guidance of regulatory affairs experts leading to better decisions, fewer delays and more timely approvals of new medical products for patients.
Introdução: A indústria biofarmacêutica na atualidade tem direcionado seus programas de desenvolvimento de produtos para abordagens mais complexas e de maior valor agregado, o que continha um grande risco associado em seu caminho para o registro sanitário. No entanto, a previsibilidade desses processos se complementa ainda mais em grande medida pela necessidade de gerenciar a forma certa desses riscos e dos grandes volumes de dados e informações a serem manipulados. As empresas farmacêuticas devem adequar seus processos de forma que contribuem para construir uma ponte entre a excelência científica das investigações e o conhecimento dos requisitos para proceder de maneira exitosa no desenvolvimento de um produto biofarmacêutico. Metodologia: O presente trabalho aborda a relação única e coerente que conforma o processo de Inteligência Regulatória. Sua aplicabilidade de forma proativa no setor biotecnológico cubano potencializaria o monitoramento adequado de um ambiente regulatório cambiante acentuado pela nova normalidade devida à COVID-19. Resultados: A evolução do panorama regulatório aumentou a necessidade de contar com informações atualizadas e interpretar a orientação dos especialistas em assuntos regulatórios que conduzem a melhores decisões, menos demoradas e aprovações mais oportunas de novas opções de produtos sanitários para os pacientes.
Referencias
1. M. Sokolov. Decision making and risk management in biopharmaceutical engineering—opportunities in the age of Covid-19 and digitalization. Industrial & Engineering Chemistry Research, 59(40), 17587–17592 (2020). https://doi.org/10.1021/acs.iecr.0c02994
2. J. O’Brien, R. Lumsden & J. Macdonald. Strengthening regulatory systems for medicines in a changed world: where do we go from here? BMJ Global Health, 6(1), e004680 (2021). https://doi.org/10.1136/bmjgh-2020-004680
3. M. Brown-Tuttle. Regulatory Intelligence 101. Regulatory Affairs Professionals Society (RAPS), 2014.
4. FREYR® blogs. Regulatory Intelligence in emerging markets. March 17, 2015. URL: https://preprod.freyrsolutions.com/es/blog/regulatory-intelligence-in-emerging-markets
5. C. Hynes. Regulatory intelligence: Implications for product development. TOPRA, 2014; 13 p. URL: http://bit.ly/2pr5UiY
6. D. Dannemiller, L. DeWitt & A. Gajjaria. Building regulatory-ready organizations: Managing regulatory and compliance risk at investment management firms. Deloitte University Press, 2017. URL: https://www.deloitte.com/us/en/insights/industry/financial-services/regulatory-and-compliance-risk-investment-management-firms.html
7. L.V. Sacks, H.H. Shamsuddin, Y.I. Yasinskaya, K. Bouri, M.L. Lanthier & R.E. Sherman. Scientific and regulatory reasons for delay and denial of FDA approval of initial applications for new drugs, 2000-2012. JAMA, 311(4), 378–384 (2014). https://doi.org/10.1001/jama.2013.282542
8. G. Tafuri, F. Trotta, H.G.M. Leufkens & L. Pani. Disclosure of grounds of European withdrawn and refused applications: a step forward on regulatory transparency. British Journal of Clinical Pharmacology, 75(4), 1149–1151 (2013). https://doi.org/10.1111/j.1365-2125.2012.04424.x
9. I. Barton, A.L.V. Avanceña, N. Gounden & R. Anupindi. Unintended consequences and hidden obstacles in medicine access in Sub-Saharan Africa. Frontiers in Public Health, 7, 342 (2019). https://doi.org/10.3389/fpubh.2019.00342
10. W.K. Sietsema & M.M. Siegenthaler. Global pharmaceutical and biologics regulatory strategy. Regulatory Affairs Professionals Society (RAPS), 2020.
11. T.C. Kühler, M. Bujar, N. McAuslane & L. Lawrence. To what degree are review outcomes aligned for new active substances (NASs) between the European Medicines Agency and the US Food and Drug Administration? A comparison based on publicly available information for NASs initially approved in the time period 2014 to 2016. BMJ Open, 9, e028677 (2019). https://doi.org/10.1136/bmjopen-2018-028677
12. A.C. Egilman, A. Kapczynski, M.E. McCarthy, A.T. Luxkaranayagam, C.J. Morten, M. Herder, J.D. Wallach & J.S. Ross. Transparency of regulatory data across the European Medicines Agency, Health Canada, and US Food and Drug Administration. Journal of Law, Medicine & Ethics, 49(3), 456–485 (2021). https://doi.org/10.1017/jme.2021.67
13. M. Batra & N.E. Storm. The elements of global regulatory strategy — The basics. RF Quarterly, 2(3), 4-19 (2022). URL: https://library.raps.org/elements_of_global_regulatory_strategy_the_basics/
14. K. Klein, P. Stolk, P. Tellner, V. Acha, S. Montagne & I. Stöckert. Regulatory flexibilities and guidances for addressing the challenges of COVID-19 in the EU: What can we learn from company experiences? Therapeutic Innovation & Regulatory Science, 56, 366–377 (2022). https://doi.org/10.1007/s43441-022-00383-3
15. United Kingdom. Medicines and Healthcare products Regulatory Agency (MHRA). Common issues identified during clinical trial applications. 22 March 2017. URL: https://www.gov.uk/government/publications/common-issues-identified-during-clinical-trial-applications
16. M. Briel, B.S. Elger, S. McLennan, S. Schandelmaier, E. von Elm & P. Satalkar. Exploring reasons for recruitment failure in clinical trials: A qualitative study with clinical trial stakeholders in Switzerland, Germany, and Canada. Trials, 22(1), 844 (2021). https://doi.org/10.1186/s13063-021-05818-0
17. Brown-Tuttle M. The Regulatory Strategist Toolbox: Clinical Endpoint Analysis Tools. Regulatory Focus. Regulatory Affairs Professionals Society (RAPS), September 2018. URL: https://www.raps.org/news-and-articles/news-articles/2018/9/the-regulatory-strategist-toolbox-clinical-endpoi
18. C. McLeod, R. Norman, E. Litton, B.R. Saville, S. Webb & T.L. Snelling. Choosing primary endpoints for clinical trials of health care interventions. Contemporary Clinical Trials Communications, 16, 100486 (2019). https://doi.org/10.1016/j.conctc.2019.100486
19. J.U. Scher & G. Schett. Key opinion leaders — A critical perspective. Nature Reviews Rheumatology, 17, 119–124 (2021). https://doi.org/10.1038/s41584-020-00539-1
20. A. Tavridou, D. Rogers, M. Bonelli, A. Schiel & A. Hidalgo-Simon. Towards a better use of scientific advice for developers of advanced therapies. British Journal of Clinical Pharmacology, 87(6), 2459–2464 (2021). https://doi.org/10.1111/bcp.14672
21. N.J. DeVito & B. Goldacre. Evaluation of compliance with legal requirements under the FDA Amendments Act of 2007 for timely registration of clinical trials, data verification, delayed reporting, and trial document submission. JAMA International Medicine, 181(8), 1128–1130 (2021). https://doi.org/10.1001/jamainternmed.2021.2036
22. BIOMAPAS. Role of the Local Person for Pharmacovigilance (LPPV). URL: https://www.biomapas.com/role-of-the-local-person-for-pharmacovigilance-lppv/
23. H.C. Ebbers, A.K. Mantel-Teeuwisse, F.A. Sayed-Tabatabaei, E.H.M. Moors, H. Schellekens & H.G.M. Leufkens. The role of Periodic Safety Update Reports in the safety management of biopharmaceuticals. European Journal of Clinical Pharmacology, 69(2), 217–226 (2013). https://doi.org/10.1007/s00228-012-1317-3
24. Organización Panamericana de Salud (OPS). Planes de gestión de riesgos e Informes periódicos de seguridad. URL: https://www.paho.org/es/temas/servicios-salud/planes-gestion-riesgos-e-informes-periodicos-seguridad
25. M. Ambani. Regulatory intelligence: It’s more than just compliance. Guest Column. Outsourced Pharma. December 3, 2021. URL: https://www.outsourcedpharma.com/doc/regulatory-intelligence-it-s-more-than-just-compliance-0001
26. K.H. Zou, J.Z. Li, J. Imperato, C.N. Potkar, N. Sethi, J. Edwards & A. Ray. Harnessing Real-World Data for regulatory use and applying innovative applications. Journal of Multidisciplinary Healthcare, 13, 671–679 (2020). https://doi.org/10.2147/jmdh.s262776
27. M. Wegner. New approaches to regulatory innovation emerging during the crucible of COVID-19: In responding to a global health crisis, industry is discovering new, efficient ways of meeting objectives. Therapeutic Innovation & Regulatory Science, 55(2), 463–466 (2021). https://doi.org/10.1007/s43441-020-00239-8
28. C.S. Ajmal, S. Yerram, V. Abishek, V.P.M. Nizam, G. Aglave, J.D. Patnam, R.S. Raghuvanshi & S. Srivastava. Innovative approaches in regulatory affairs: Leveraging artificial intelligence and machine learning for efficient compliance and decision-making. The AAPS Journal, 27, 22 (2025). https://doi.org/10.1208/s12248-024-01006-5
29. European Medicines Agency (EMA). Leveraging the power of data for public and animal health. May 2025. URL: https://www.ema.europa.eu/en/news/leveraging-power-data-public-animal-health
30. European Medicines Agency (EMA). 2024 AI Observatory Report. Amsterdam, May 2025; 3 p. URL: https://www.ema.europa.eu/en/documents/report/2024-ai-observatory-report_en.pdf
31. A.O. Aderibigbe, P.E. Ohenhen, N.K. Nwaobia, J.O. Gidiagba & E.C. Ani. Artificial intelligence in developing countries: Bridging the gap between potential and implementation. Computer Science & IT Research Journal, 4(3), 185–199 (2023). https://doi.org/10.51594/csitrj.v4i3.629
32. D. Drago & M.M. Lumpkin. Reliance-based regulatory pathways – The key to smart(er) regulation? GlobalForum, 2022. URL: https://globalforum.diaglobal.org/issue/march-2022/reliance-based-regulatory-pathways-the-key-to-smarter-regulation/
33. P.K. Drain, R.A. Parker, M. Robine, K.K. Holmes & I.V. Bassett. Correction: global migration of clinical research during the era of trial registration. PLoS One, 13(6), e0199952 (2018). https://doi.org/10.1371/journal.pone.0199952
34. A. Lage-Dávila. Por qué la biotecnología no debe ser excepción. CUBADEBATE: Por la Verdad y las Ideas. Artículo de Opinión 9 mayo 2022. URL: http://www.cubadebate.cu/opinion/2022/05/09/por-que-la-biotecnologia-no-debe-ser-excepcion/
35. B. Romeu & R. Perez Cristiá. The CECMED Office of Innovation: A core initiative to bolster novel pharmaceutical products-The Cuban approach. Therapeutic Innovation & Regulatory Science, 55, 163–169 (2021). https://doi.org/10.1007/s43441-020-00202-7
36. J. Schueler & T. Ostler. Biopharmaceutical startup’s need of regulatory intelligence. Journal of Commercial Biotechnology, 22(1), 6–14 (2016). URL: https://bioaspekte.de/images/Articles/2016jcb_regulatorystrategy.pdf
37. M. Contardi. Changes in the medical device’s regulatory framework and its impact on the medical device’s industry: From the medical device directives to the medical device regulations. Erasmus Law Review, 2, 166–177 (2019). https://doi.org/10.5553/elr.000139
38. R. Ojha & V. Laddha. Regulatory intelligence - Need of the hour. Asian Journal of Pharmaceutical Research and Development, 1(2), 117–121 (2013). URL: https://ajprd.com/index.php/journal/article/view/66
39. H.S. Chahal, F. Kashfipour, M. Susko, N.S. Feachem & C. Boyle. Establishing a regulatory value chain model: An innovative approach to strengthening medicines regulatory systems in resource-constrained settings. Revista Panamericana de Salud Pública, 39(5), 299–305 (2016). URL: https://www.scielosp.org/pdf/rpsp/2016.v39n5/299-305/en
40. T. Peters, N. Soanes, M. Abbas, J. Ahmad, J.-C. Delumeau, E. Herrero-Martinez, et al. Effective pharmacovigilance system development: EFPIA-IPVG consensus recommendations. Drug Safety, 44, 17–28 (2021). https://doi.org/10.1007/s40264-020-01008-0
41. E. Huddle, S. Dib & M.C. Aquilina. Regulatory intelligence – Delivering regionally, operating globally. Regulatory Focus. Regulatory Affairs Professionals Society (RAPS), 2017. URL: https://www.raps.org/News-and-Articles/News-Articles/2017/1/Regulatory-Intelligence-Delivering-Regionally-O#citation
42. HUTCHMED receives complete response letter from the U.S. FDA for surufatinib for the treatment of advanced neuroendocrine tumors. HUTCHMED Press Release. URL: https://www.hutch-med.com/suru-fda-nda/
43. A.E. Mulberg, C. Bucci-Rechtweg, J. Giuliano, D. Jacoby, F.K. Johnson, Q. Liu, et al. Regulatory strategies for rare diseases under current global regulatory statutes: a discussion with stakeholders. Orphanet Journal of Rare Diseases, 14, 36 (2019). https://doi.org/10.1186/s13023-019-1017-5
44. B. Sharma, A. Gurung, P. Pradhan, D. Darjee & N.K. Kotla. Navigating the regulatory landscape: Key trends shaping today's regulatory affairs environment. International Journal of Drug Regulatory Affairs, 11(4), 87–92 (2023). https://doi.org/10.22270/ijdra.v11i4.639
45. A.E. Lottes, K.J. Cavanaugh, Y.Y.-F. Chan, V.J. Devlin, C.J. Goergen, R. Jean, et al. Navigating the regulatory pathway for medical devices-a conversation with the FDA, clinicians, researchers, and industry experts. Journal of Cardiovascular Translational Research, 15(5), 927–943 (2022). https://doi.org/10.1007/s12265-022-10232-1
46. K. Messmer. Background and skill set needed for a regulatory intelligence professional. En: W. Sietsema & D. Ashraf (editores). Regulatory Intelligence 101, 3rd ed. Regulatory Affairs Professionals Society (RAPS), 2021; pp. 23–32.
Cómo citar
APA
ACM
ACS
ABNT
Chicago
Harvard
IEEE
MLA
Turabian
Vancouver
Descargar cita
Visitas a la página del resumen del artículo
Descargas
Licencia
Derechos de autor 2026 Revista Colombiana de Ciencias Químico-Farmacéuticas
Esta obra está bajo una licencia internacional Creative Commons Atribución 4.0.
El Departamento de Farmacia de la Facultad de Ciencias de la Universidad Nacional de Colombia autoriza la fotocopia de artículos y textos para fines de uso académico o interno de las instituciones citando la fuente. Las ideas emitidas por los autores son responsabilidad expresa de estos y no de la revista.
Todo el contenido de esta revista, excepto dónde está identificado, está bajo una Licencia Creative Commons de Atribución 4.0 aprobada en Colombia. Consulte la normativa en: http://co.creativecommons.org/?page_id=13
