A16. Navigating the Transition from Provisional to Full Approval: Insights from TGA and Medsafe
Tracks
Prescription Medicine Regulation
| Tuesday, June 3, 2025 |
| 2:45 PM - 3:45 PM |
| Pyrmont Theatre |
Chair & Speakers
Chris James
Group Manager
Medsafe
Navigating the Transition from Provisional to Full Approval: Insights from TGA and Medsafe
Abstract
The provisional approval pathway, introduced by the TGA in 2016, has been instrumental in expediting patient access to new medicines and indications in Australia, particularly during the during the COVID-19 pandemic. Now, five years after the pandemic's onset, emerging confirmatory data offers opportunities for transitioning these therapeutics to full registration. While TGA provides a step-by-step guide for this process, additional strategies can further support applicants. This session will offer practical tips and advice beyond the published guidance to streamline the transition from provisional to full approval. Similarly, in New Zealand, the Medsafe Guideline on the Regulation of Therapeutic Products in New Zealand, New Medicine Applications (January 2023) outlines Medsafe expectations for converting provisional consent to full consent. Medsafe will provide an in-depth overview of the conversion pathway, including details on application form requirements, fee categories, and data requirements.
Biography
Chris is the Group Manager of Medsafe, the medicine and medical device regulator in New Zealand. Chris is also the Group Manager for the Medicinal Cannabis Agency.
Chris is a registered pharmacist and holds post graduate qualifications in public health. In 2006 he joined Medsafe, initially in the pharmaceutical chemistry assessment of new medicines, then moving to the post market pharmacovigilance team.
Chris has experience in risk communication including developing the early warning and alert system to provide information about new and emerging safety issues.
Chris has been Medsafe Group Manager since 2015.
Mohit Khera
Director (A/g)
TGA, Prescription Medicine Authorisation Branch
Navigating the Transition from Provisional to Full Approval: Insights from TGA and Medsafe
Abstract
The provisional approval pathway, introduced by the TGA in 2016, has been instrumental in expediting patient access to new medicines and indications in Australia, particularly during the during the COVID-19 pandemic. Now, five years after the pandemic's onset, emerging confirmatory data offers opportunities for transitioning these therapeutics to full registration. While TGA provides a step-by-step guide for this process, additional strategies can further support applicants. This session will offer practical tips and advice beyond the published guidance to streamline the transition from provisional to full approval. Similarly, in New Zealand, the Medsafe Guideline on the Regulation of Therapeutic Products in New Zealand, New Medicine Applications (January 2023) outlines Medsafe expectations for converting provisional consent to full consent. Medsafe will provide an in-depth overview of the conversion pathway, including details on application form requirements, fee categories, and data requirements.
Biography
Dr Mohit Khera is a Director (A/g) (Clinical) in Prescription Medicines Authorisation Branch, TGA. Dr Khera is registered Medical Practitioner with Medical Board, Ahpra, Australia. Dr Khera trained in Clinical Rehabilitation medicine in the NHS, UK and has a Certificate of Completion of Specialist Training in Pharmaceutical medicine, acquired-Joint Committee on Higher Medical Training, Royal College of Physicians and GMC, UK. He is a Fellow of Faculty of Pharmaceutical Medicine, Royal College of Physician RCP, UK. Dr Khera has been an Investigator for Phase 1 and Phase 2 studies at the St. George’s Hospital Medical School, London and Global Phase 4 studies. Dr Khera has been an academia researcher at Menzies Research Institute Tasmania, Hobart and Monash University, Melbourne. Dr Khera has been in Pharmaceutical industry Medical Affairs lead roles in the UK and Australia. Dr Khera has been a Medicines Australia and ABPI (UK) final signatory for medico-marketing programmes.
