OR WAIT 15 SECS
© 2020 MJH Life Sciences and BioPharm International. All rights reserved.
© 2020 MJH Life Sciences™ and BioPharm International. All rights reserved.
October 15, 2020
Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.
Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.
July 16, 2020
Global regulatory authorities have published a report describing the aligned positions on COVID-19 vaccine development, which were agreed upon by meeting participants of the second workshop on COVID-19 vaccine development.
March 15, 2020
With some FDA inspections on hold, will the US drug supply maintain its quality standards?
Monographs are developed based on the submission of information and materials from a company having regulatory approval for the product, and this submission feeds into the pharmacopoeia revision process.
This final article in the series has two purposes: to summarize all the considerations that go into a company’s compendial affairs program and to look ahead at topics that will likely result in further evolution in the pharmacopoeias around the world.
This article returns to the topic of complying with pharmacopoeial requirements with a case study at the intersection of monograph development and compliance.
December 15, 2019
The revision process and the resulting publication of proposed and official updates for pharmacopoeias around the world are described.