2020年2月10日 · In vitro diagnostics are also the first line of defence against the possibility of the re-emergence of eradicated diseases. Smallpox, for example, is unlikely to reappear; however, WHO maintains a network of partnerships around the world dedicated to the rapid diagnosis and containment of any potential cases.

2021年6月14日 · Technical specifications for selection of essential in vitro diagnostics for SARS-CoV-2 NOTE: This publication is under review and a new version will be published during the third quarter of 2022. Technical specifications for in vitro diagnostics...

2021年1月28日 · It is expected that national essential diagnostics lists will provide similar benefits and improve access to essential in vitro diagnostic tests. It will also contribute towards health systems strengthening and realizing universal health coverage , which is central to Goal 3 of the Sustainable Development Goals (Ensure healthy lives and promote ...

2019年11月20日 · This document is intended to provide a convenient reference to the second edition of the WHO Model List of Essential In Vitro diagnostics (EDL). The EDL presented here provides abbreviated information including the EDL table itself and should be read and interpreted with reference to the report of the second meeting of the WHO Strategic Advisory Group of …

2023年10月18日 · Technical report of the fourth meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics, 2022 (including the fourth WHO model list of essential in vitro diagnostics (EDL 4)). This report also includes the applications received for the EDL 4 and a summary of the deliberations and recommendations by the SAGE IVD members and the …

The WHO Emergency Use Listing (EUL) is open to candidate in vitro diagnostics (IVDs) to detect SARS-CoV-2 (originally called 2019-nCoV). Since 28 February 2020, manufacturers of IVDs for the detection of SARS-CoV-2 nucleic acid are invited to submit an Expression of Interest (EoI) for assessment of candidate IVDs under the EUL procedure.

10.4 In vitro equivalence testing for non-oral dosage forms 227 10.5 In vitro equivalence testing for scale-up and post-approval changes 229 References 229 Appendix 1 Recommendations for conducting and assessing comparative dissolution profiles 232 Appendix 2 Equilibrium solubility experiments for the purpose of classification of

2021年1月29日 · The group also oversees maintenance of the WHO Model List of Essential In Vitro Diagnostics (EDL), which serves as an evidence-based reference point for countries to develop their own national lists to guide how they choose and use IVDs.

2021年6月20日 · Post-market surveillance is a set of activities conducted by manufacturers, to collect and evaluate experience gained from medical devices that have been placed on the market, and to identify the need to take any action. Post-market surveillance is a crucial tool to ensure that medical devices continue to be safe and well performing, and to ensure actions …

The WHO Emergency Use Listing Procedure (EUL) is a risk-based procedure for assessing and listing unlicensed vaccines, therapeutics and in vitro diagnostics with the ultimate aim of expediting the availability of these products to people affected by a public health emergency.