Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

COVID-19 Prompts WHO To Waive Onsite Prequalification Inspections

Executive Summary

Agency describes criteria for waiving routine prequalification inspections for existing drugs and vaccines as well as new products in light of COVID-19.

You may also be interested in...



COVID-19 Prompts WHO To Propose Revisions To GMPs For Investigational Drugs Guideline

Accelerated development of COVID-19 products prompts World Health Organization to revise a guideline on good manufacturing practices for investigational drugs and propose a new guideline applying GMP principles to R&D facilities.

US FDA Explains How It Will Resume Inspections Suspended By Pandemic

Phased approach will prioritize the safety of FDA and industry employees while striking an appropriate balance between a scaled-back surveillance inspection program and the continuation of providing robust regulatory oversight,’ Commissioner Hahn says in a memo from self-isolation.

COVID-19 May Delay WHO’s Prequalification Of Drugs, Devices, IVDs

Work and movement-related restrictions are affecting the ability of companies to provide a timely response to questions relating to their prequalification dossiers.

Related Content

Topics

UsernamePublicRestriction

Register

LL1134531

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel