Emergency approvals – moving things along in a Pandemic 09 April 2020
With disrupted supply chains, shortages of medicines, masks, ventilators and test kits, everyone wants the regulator’s attention – right now, today. The good news is that pandemic planning has been a thing for regulators for many years. And they have the powers and the laws to do things differently. From expedited reviews to waivers of change applications to emergency supply approvals without product registrations, it all becomes possible. Regulators still expect to see some sort of evidence of safety and efficacy though it may be much more flexibly interpreted.
Do you want to get a medical device or medicine approved quickly in response to COVID-19? Hear from Arthur Brandwood and Robert Stringer as they discuss how Australia’s TGA has become fleet of foot in these troubled times.