Regulatory reliance to approve new medicinal products in Latin American and Caribbean countries
Bibliographic Data
| ID | 14965702 |
|---|---|
| Authors | Carlos E Durán (0000-0003-1853-3641, Ghent University Hospital, corresponding author), Martín Cañás (0000-0003-0500-5866, Ministerio de Salud - Provincia de Buenos Aires), Martín Urtasun (0000-0001-6018-8250, Ministerio de Salud - Provincia de Buenos Aires), Martín A Urtasun, Monique Elseviers (0000-0001-9415-6900, Ghent University Hospital), Tatiana Andia (0000-0003-1805-2549, Universidad de los Andes), Robert Vander Stichele (0000-0001-9118-9651, Ghent University Hospital), Thierry Christiaens (0000-0003-4064-2908, Ghent University Hospital) |
| Year | 2021 |
| Volume | 45 |
| Pages | 1-10 |
| Publication date | 2021-01-01 |
| Open Access | Yes |
| Type | ARTICLE |
| Venue | Revista Panamericana de Salud Pública (JOURNAL) |
| Journal identifiers | ISSN: 1020-4989 • E-ISSN: 1680-5348 |
| Publisher | Pan American Health Organization (PUBLISHER • US) |
| DOI | 10.26633/rpsp.2021.10 |
| PMID | 33859678 |
| OpenAlex | W3155755939 |
| Language | EN |
| Citations received | 6 |
| References cited | 5 |
Regulatory 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
Agency (philosophy · Authorization · Business · Caribbean region · Economic growth · Economics · Jurisdiction · Latin Americans · Legislation · Marketing authorization · Political science · Regulatory authority · Regulatory science · Biomedical Ethics and Regulation · Biosimilars and Bioanalytical Methods · Law · Medicine · Pharmaceutical Economics and Policy · Public Administration
Between knowledge and politics. Negotiating and objectifying standards and measures in Latin America
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| Citations per year | 1.2 |
|---|---|
| Citation span | 2021 - 2026 (6) |
| Highly cited | No |