Yesterday we looked at the response from the authorities in Middle East & Latin America (COVID-19 – Regulators Respond – Middle East & Latin America Focus). Today we’ll be focusing on Australia & New Zealand.
Many aspects of our lives have been affected by the pandemic which has seen cases and deaths around the world.
The pharmaceutical industry has by no means escaped this impact. We have experienced an increase in demand for products used to treat COVID-19 symptoms; the disruption of product supply; an impact on manufacturing, clinical trials and R&D, the curtailment of on-site inspections, problems in meeting timelines and requirements set by regulatory agencies, I could go on…
So far in this mini blog series we have looked at flexibilities from the EU, UK, USA, India and the Middle East and Latin America. Today we are looking at the regulatory responses in Australia and New Zealand.
The Australian agency, the TGA, is expediting assessment of variations for medicines in short supply. Approval timelines have been significantly reduced e.g. from 45 working days to 8.
The TGA has introduced remote GMP inspections based on risk form July 2020.
GovTEAMS TGA portal may be used for submission of large dossiers. This cannot be used for sequences which can be sent via email or uploaded to the TBS portal.
TGA are in line with EU GMP validity e.g. for sites located in or outside of the EEA the validity of GMP certificates will be extended until end of 2021. There is no need for further action unless you are changing the scope of the certificate e.g. adding new buildings/ products etc.
In the case of an out of stock situation – if it relates to a PHARMAC funded medicine, then applicants can request an expedited variation review process from Medsafe. The agency have initiated a temporary electronic file transfer system (EFT) to companies to enable submissions to be made electronically. Medsafe does not accept CDs or paper submissions.
Medsafe recognises the extension provided by the EU for GMP Certificates on EudraGMP until the end of 2021. The agency is also accepting declarations from manufacturers where undated GMP evidence is not available due to COVID travel restrictions.