ArticleRevista panamericana de salud publica = Pan American journal of public health2021
Regulatory reliance to approve new medicinal products in Latin American and Caribbean countries.
Article in Revista panamericana de salud publica = Pan American journal of public health, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
22 citing papers in PubMed, 42 citations in OpenAlex.
- Regulatory Reliance in Latin America: Opportunities and Implementation Challenges for International Pharmaceutical Companies.Therapeutic innovation & regulatory science · 2026Review
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- Efficacy and Safety of Anti-PD-(L)1 Treatments: A Systematic Review and Meta-Analysis of Asian vs Non-Asian Patients with Esophageal Squamous Cell Carcinoma.Gastro hep advances · 2026Review
- Access to Reserve Antibiotics in Latin America and the Caribbean: Situation, Challenges, and Future Directions.Infection and drug resistance · 2026Review
- Global research progress in antibody-drug conjugates for solid tumors: Bibliometrics and visualized analysis.Human vaccines & immunotherapeutics · 2025Review
- Clinical and economic impact of the availability of innovative therapies for advanced lung cancer in men in Latin America: a population-based secondary data study.Lancet regional health. Americas · 2025Article
- The therapeutic futility paradox: insights from oncological drug litigation in Ecuador.Frontiers in medicine · 2025Article
- EU's Extraterritorial Obligations for Global Medicine Access Under the Convention on the Rights of Persons with Disability (CPRD).The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics · 2025Article
- Trust Beyond Borders: European External Regulatory Influence on Access to Medicines.The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics · 2025Article
- Comparison between European Medicines Agency and US Food and Drug Administration in Granting Accelerated Marketing Authorizations for Covid-19 Medicines and their Utilized Regulations.Therapeutic innovation & regulatory science · 2024Article
- Methodological guidelines and publications of benefit-risk assessment for health technology assessment: a scoping review protocol.BMJ open · 2023Article
- Comparison of the Latin America Regulation Landscape and International Reference Health Authorities to Hasten Drug Registration and Clinical Research Applications.Therapeutic innovation & regulatory science · 2023Article
- Regulatory, health technology assessment and company interactions: the current landscape and future ecosystem for drug development, review and reimbursement.International journal of technology assessment in health care · 2023Article
- Regulatory agilities impacting review timelines for Pfizer/BioNTech's BNT162b2 mRNA COVID-19 vaccine: a retrospective study.Frontiers in medicine · 2023Article
- Review time of oncology drugs and its underlying factors: an exploration in China.Frontiers in pharmacology · 2023Article
- Cancer Therapy Approval Timings, Review Speed, and Publication of Pivotal Registration Trials in the US and Europe, 2010-2019.JAMA network open · 2022Article
- Medicines Regulatory Science Expertise in Africa: Workforce Capacity Development and Harmonisation Activities Towards the Establishment of the African Medicines Agency.Pharmaceutical medicine · 2022Article
- The Hitchhiker's Guide to Human Therapeutic Nanoparticle Development.Pharmaceutics · 2022Review
- Regulatory reliance pathways during health emergencies: enabling timely authorizations for COVID-19 vaccines in Latin America.Revista panamericana de salud publica = Pan American journal of public health · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo describe the current status of regulatory reliance in Latin America and the Caribbean (LAC) by assessing the countries' regulatory frameworks to approve new medicines, and to ascertain, for each country, which foreign regulators are considered as trusted regulatory authorities to rely on.
methodsWebsites from LAC regulators were searched to identify the official regulations to approve new drugs. Data collection was carried out in December 2019 and completed in June 2020 for the Caribbean countries. Two independent teams collected information regarding direct recognition or abbreviated processes to approve new drugs and the
resultsRegulatory documents regarding marketing authorization were found in 20 LAC regulators' websites, covering 34 countries. Seven countries do not accept reliance on foreign regulators. Thirteen regulatory authorities (Argentina, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Mexico, Panama, Paraguay, Peru, Uruguay, and the unique Caribbean Regulatory System for 15 Caribbean States) explicitly accept relying on marketing authorizations issued by the European Medicines Agency, United States Food and Drug Administration, and Health Canada. Ten countries rely also on marketing authorizations from Australia, Japan, and Switzerland. Argentina, Brazil, Chile, and Mexico are reference authorities for eight LAC regulators.
conclusionsRegulatory reliance has become a common practice in the LAC region. Thirteen out of 20 regulators directly recognize or abbreviate the marketing authorization process in case of earlier approval by a regulator from another jurisdiction. The regulators most relied upon are the European Medicines Agency, United States Food and Drug Administration, and Health Canada.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.