ArticleAfrican journal of laboratory medicine2014
Improving access to new diagnostics through harmonised regulation: priorities for action.
Article in African journal of laboratory medicine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 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
16 citing papers in PubMed, 42 citations in OpenAlex.
- The future of diagnostics in Africa.Nature medicine · 2026Review
- Evolving Landscape of Emerging Virus Diagnosis: Challenges and Innovations.Molecular biotechnology · 2026Review
- Advancing clinical biochemistry: addressing gaps and driving future innovations.Frontiers in medicine · 2025Review
- Improving the efficiency of the regulatory approvals of HIV in vitro diagnostics in low- and middle-income countries: Perspective of the IAS Industry Liaison Forum diagnostic partners.PLOS global public health · 2025Article
- Medical device regulation and oversight in African countries: a scoping review of literature and development of a conceptual framework.BMJ global health · 2023Article
- Use of Physical Accessibility Modelling in Diagnostic Network Optimization: A Review.Diagnostics (Basel, Switzerland) · 2022Review
- Systems and processes for regulation of investigational medical devices in Uganda.Frontiers in medical technology · 2022Article
- The Lancet Commission on diagnostics: transforming access to diagnostics.Lancet (London, England) · 2021Review
- Keep the quality high: the benefits of lot testing for the quality control of malaria rapid diagnostic tests.Malaria journal · 2020Article
- Strategies for Heterogeneous R&D Alliances of In Vitro Diagnostics Firms in Rapidly Catching-Up Economies.International journal of environmental research and public health · 2020Article
- Preparing national tiered laboratory systems and networks to advance diagnostics in Africa and meet the continent's health agenda: Insights into priority areas for improvement.African journal of laboratory medicine · 2020Article
- Regulation of HIV self-testing in Malawi, Zambia and Zimbabwe: a qualitative study with key stakeholders.Journal of the International AIDS Society · 2019Article
- Health care workers' perceptions of point-of-care testing in a low-income country-A qualitative study in Southwestern Uganda.PloS one · 2017Article
- Rapid diagnostic tests for malaria.Bulletin of the World Health Organization · 2015Article
- Diagnostics for Developing Countries.Diagnostics (Basel, Switzerland) · 2015Article
- Regulation of medical diagnostics and medical devices in the East African community partner states.BMC health services research · 2014Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
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 or overzealous 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, as well 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.
Identifiers
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.