Work Item
ASTM WK73465
New Guide for Accelerated CMC development, manufacture and supply of therapies and vaccines for use in pandemics such as COVID-19
1. Scope
This guide provides recommendations for approaches to Chemistry, Manufacturing and Controls (CMC) and Good Manufacturing Practices (GMP) to support the accelerated development, manufacture and supply of new vaccines and treatments for use in pandemics such as COVID-19.
Keywords
Regulatory flexibility; anti-viral; medicine;
Rationale
The approaches in this guide can provide a framework for the basis for discussion with regulatory authorities to enable companies to understand the information needed to satisfy regulatory requirements for the Quality module of a Marketing Authorization Application for medicine or vaccine for use in the pandemic, and the Good Manufacturing and Distribution Practices for supply of the medicine, when new medicines must be developed and supplied in accelerated timelines and potentially is large quantities for use around the world.
The title and scope are in draft form and are under development within this ASTM Committee.
Work Item Status
Date Initiated: 07-03-2020
Technical Contact: Graham Cook
Item: 002
Ballot: E55 (20-05)
Status: Negative Votes Need Resolution