COVID-19 updates

Minimum requirements that medical devices (ventilators, pressure-swing-adsorption plants, oxygen therapy and monitoring devices, infusion devices, portable ultrasound) must comply with to ensure quality, safety and effectiveness for management of COVID-19

This document is a compilation of relevant WHO guidance in the area of pharmaceutical quality assurance and regulatory guidelines for medicines as published in WHO’s Technical Report Series

This document provides examples of existing WHO guidance documents for vaccines and biologicals adopted by WHO Expert Committee on Biological Standardization, published in WHO’s Technical Report Series.

This document provides a framework on how regulatory authorities in low- and middle-income countries can help to mitigate medical product shortages

This document from International Coalition of Medicines Regulatory Authorities (ICMRA) lists recommendation for collective support by Medicines Regulatory Authorities to counter the global COVID-19 pandemic

Indian Council of Medical Research  has established a fast-track mechanism for validation of Indian COVID-19 testing kits for commercial use

To encourage research and development of in-vitro diagnostic kits for diagnosis of COVID-19, the Central Drugs Standard Control Organization, Government of India will process applications on high priority

To speed up research and development of a drug or vaccine for COVID-19, the Drugs Controller General of India will process applications on high priority

World Customs Organization has developed a quick guide to Harmonized System (HS) classification reference for COVID-19 medical supplies