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March 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.
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.
March 13, 2020
The National Institute for Health and Care Excellence (NICE) has issued a positive recommendation for Teva Pharmaceutical’s migraine therapy, Ajovy (fremanezumab).
EMA, along with its partners across the European medicines regulatory network, are keeping a close watch on the pharmaceutical supply chains in the European Union as a result of the potential impact of COVID-19.
March 06, 2020
European Union and national authorities are continuing to work on the prevention and management of nitrosamine impurities in medicines.
The global safety organization of Novartis is in the process of conducting a comprehensive review of a limited number of cases where patients treated with Beovu (brolucizumab) have experienced severe vision loss, inflammation, and potential retinal vasculitis.
March 02, 2020
No matter why change may be needed, it is important to comply with all the relevant regulatory requirements, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.