Matches in SemOpenAlex for { <https://semopenalex.org/work/W2023689383> ?p ?o ?g. }
- W2023689383 abstract "A new generation of diagnostic tests is being developed for use at the point of care that could save lives and reduce the spread of infectious diseases through early detection and treatment. It is important that patients in developing countries have access to these products at affordable prices and without delay. Regulation of medical products is intended to ensure safety and quality whilst balancing the need for timely access to beneficial new products. Current regulatory oversight of diagnostic tests in developing countries is highly variable and weak regulation allows poor-quality tests to enter the market. However, inefficient orover zealous regulation results in unnecessary delays, increases costs and acts as a barrier to innovation and market entry. Setting international standards and streamlining the regulatory process could reduce these barriers. Four priority activities have been identified where convergence of standards and protocols or joint review of data would be advantageous: (1) adoption of a common registration file for pre-market approval; (2) convergence of quality standards for manufacturing site inspections; (3) use of common evaluation protocols, aswell as joint review of data, to reduce unnecessary duplication of lengthy and costly clinical performance studies; and (4) use of networks of laboratories for post-market surveillance in order to monitor ongoing quality of diagnostic devices. The adoption and implementation of such measures in developing countries could accelerate access to new diagnostic tests that are safe and affordable." @default.
- W2023689383 created "2016-06-24" @default.
- W2023689383 creator A5024271503 @default.
- W2023689383 creator A5040282103 @default.
- W2023689383 creator A5084237972 @default.
- W2023689383 date "2014-04-04" @default.
- W2023689383 modified "2023-10-15" @default.
- W2023689383 title "Improving access to new diagnostics through harmonised regulation: priorities for action" @default.
- W2023689383 cites W1562219715 @default.
- W2023689383 cites W1748737970 @default.
- W2023689383 cites W2003061181 @default.
- W2023689383 cites W2012144531 @default.
- W2023689383 cites W2042680533 @default.
- W2023689383 cites W2055933450 @default.
- W2023689383 cites W2058081235 @default.
- W2023689383 cites W2068818174 @default.
- W2023689383 cites W2089407186 @default.
- W2023689383 cites W2099645926 @default.
- W2023689383 cites W2127073450 @default.
- W2023689383 cites W2140653229 @default.
- W2023689383 cites W2151160139 @default.
- W2023689383 cites W2162720994 @default.
- W2023689383 cites W2164435512 @default.
- W2023689383 cites W3121611380 @default.
- W2023689383 cites W4238750842 @default.
- W2023689383 cites W4240650446 @default.
- W2023689383 cites W4293761358 @default.
- W2023689383 doi "https://doi.org/10.4102/ajlm.v3i1.123" @default.
- W2023689383 hasPubMedCentralId "https://www.ncbi.nlm.nih.gov/pmc/articles/5637758" @default.
- W2023689383 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/29043177" @default.
- W2023689383 hasPublicationYear "2014" @default.
- W2023689383 type Work @default.
- W2023689383 sameAs 2023689383 @default.
- W2023689383 citedByCount "33" @default.
- W2023689383 countsByYear W20236893832014 @default.
- W2023689383 countsByYear W20236893832015 @default.
- W2023689383 countsByYear W20236893832017 @default.
- W2023689383 countsByYear W20236893832018 @default.
- W2023689383 countsByYear W20236893832019 @default.
- W2023689383 countsByYear W20236893832020 @default.
- W2023689383 countsByYear W20236893832021 @default.
- W2023689383 countsByYear W20236893832022 @default.
- W2023689383 countsByYear W20236893832023 @default.
- W2023689383 crossrefType "journal-article" @default.
- W2023689383 hasAuthorship W2023689383A5024271503 @default.
- W2023689383 hasAuthorship W2023689383A5040282103 @default.
- W2023689383 hasAuthorship W2023689383A5084237972 @default.
- W2023689383 hasBestOaLocation W20236893831 @default.
- W2023689383 hasConcept C10138342 @default.
- W2023689383 hasConcept C111472728 @default.
- W2023689383 hasConcept C111919701 @default.
- W2023689383 hasConcept C112930515 @default.
- W2023689383 hasConcept C118518473 @default.
- W2023689383 hasConcept C138885662 @default.
- W2023689383 hasConcept C144133560 @default.
- W2023689383 hasConcept C162324750 @default.
- W2023689383 hasConcept C182306322 @default.
- W2023689383 hasConcept C18903297 @default.
- W2023689383 hasConcept C21547014 @default.
- W2023689383 hasConcept C2777481183 @default.
- W2023689383 hasConcept C2779530757 @default.
- W2023689383 hasConcept C38652104 @default.
- W2023689383 hasConcept C41008148 @default.
- W2023689383 hasConcept C86803240 @default.
- W2023689383 hasConcept C98045186 @default.
- W2023689383 hasConceptScore W2023689383C10138342 @default.
- W2023689383 hasConceptScore W2023689383C111472728 @default.
- W2023689383 hasConceptScore W2023689383C111919701 @default.
- W2023689383 hasConceptScore W2023689383C112930515 @default.
- W2023689383 hasConceptScore W2023689383C118518473 @default.
- W2023689383 hasConceptScore W2023689383C138885662 @default.
- W2023689383 hasConceptScore W2023689383C144133560 @default.
- W2023689383 hasConceptScore W2023689383C162324750 @default.
- W2023689383 hasConceptScore W2023689383C182306322 @default.
- W2023689383 hasConceptScore W2023689383C18903297 @default.
- W2023689383 hasConceptScore W2023689383C21547014 @default.
- W2023689383 hasConceptScore W2023689383C2777481183 @default.
- W2023689383 hasConceptScore W2023689383C2779530757 @default.
- W2023689383 hasConceptScore W2023689383C38652104 @default.
- W2023689383 hasConceptScore W2023689383C41008148 @default.
- W2023689383 hasConceptScore W2023689383C86803240 @default.
- W2023689383 hasConceptScore W2023689383C98045186 @default.
- W2023689383 hasIssue "1" @default.
- W2023689383 hasLocation W20236893831 @default.
- W2023689383 hasLocation W20236893832 @default.
- W2023689383 hasLocation W20236893833 @default.
- W2023689383 hasLocation W20236893834 @default.
- W2023689383 hasLocation W20236893835 @default.
- W2023689383 hasOpenAccess W2023689383 @default.
- W2023689383 hasPrimaryLocation W20236893831 @default.
- W2023689383 hasRelatedWork W1542828274 @default.
- W2023689383 hasRelatedWork W1552305846 @default.
- W2023689383 hasRelatedWork W1926369042 @default.
- W2023689383 hasRelatedWork W2211347220 @default.
- W2023689383 hasRelatedWork W2277754909 @default.
- W2023689383 hasRelatedWork W2899084033 @default.
- W2023689383 hasRelatedWork W3125375134 @default.
- W2023689383 hasRelatedWork W3141446821 @default.
- W2023689383 hasRelatedWork W3143173726 @default.
- W2023689383 hasRelatedWork W85446892 @default.