Australia issues revised guidance, forms on minor variations to prescription drugs
This article was originally published in SRA
Executive Summary
Australia's Therapeutic Goods Administration is inviting feedback on revised guidelines and related application forms that, when finalised and implemented in 2013, will make it easier for companies to make minor variations to registered prescription medicines1.
You may also be interested in...
COVID-19 Vaccines Donated To Philippines Require Emergency Use Authorization
Days after a senior Chinese government official offered free COVID-19 vaccines to the Philippines government, the country’s medicines regulator said the donated jabs would need an emergency approval before they can be used on the public.
EDQM Sets 2023 Target For Modernizing ‘Certificates Of Suitability’
The European Directorate for the Quality of Medicines & HealthCare is proceeding carefully to find the right balance between serving the diverse requirements of various stakeholders that make use of its ‘certificates of suitability.’
Global Regulators Issue Advice On Clinical Comparability Of Biosimilar MAbs
The International Pharmaceutical Regulators Programme has documented various approaches currently being used for the clinical comparability of biosimilar monoclonal antibodies in different jurisdictions.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: