New guidance from the
EMA has been published in March 2020. This guideline provides a framework to
facilitate the management of post-approval Chemistry, Manufacturing and
Controls (CMC) changes in a more predictable and efficient manner. A harmonised approach regarding technical and
regulatory considerations for lifecycle management will benefit patients,
industry, and regulatory authorities by promoting innovation and continual
improvement in the pharmaceutical sector, strengthening quality assurance and improving
supply of medicinal products.
The focus is with pharmaceutical
drug substances (APIs) and products (both chemical and biological) that require
a marketing authorization; drug-device combination products; and with analytical
methods.
Posted by Dr. Tim Sandle,
Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)
No comments:
Post a comment
Pharmaceutical Microbiology Resources