I, Jonathan Coleman, Minister of Health, pursuant to section 96C(1) of the Medicines Act 1981 (“the Act”), hereby authorise Living Cell Technologies Limited (LCT) to conduct a clinical trial involving xenotransplantation as described in its application dated the 21st day of August 2015 for protocol number LCT/PD-015, subject to the following conditions:
- In the event that LCT ceases trading in New Zealand, it will transfer its tissue stores and patient data relating to the trial to the Ministry of Health.
- LCT is, on request, to provide to the Ministry of Health (or such other person or organisation as the Minister may nominate for the purpose) any patient information and tissue samples required for the purposes of establishing and maintaining a government administered national patient register and tissue archive.
- All LCT laboratory facilities are subject to inspections from Medsafe, International Accreditation New Zealand, or any person nominated by the Minister at any time during the trial, within normal working hours.
- LCT will, when directed by Medsafe, provide a report on their compliance with any new or amended international guidelines on xenotransplantation (including those being developed by the World Health Organization), including details of how they will amend their study, if required, to bring it into compliance.
- LCT will provide Medsafe with evidence that an accredited Health and Disability Ethics committee has considered and approved the NTCELL study protocol and associated documents.
- LCT will provide Medsafe with evidence that the Good Manufacturing Practice certificate for its manufacturing site includes manufacture of NTCELL.
This conditional authorisation will remain in effect for the period that the clinical trial has been approved by an accredited Health and Disability Ethics committee, unless sooner varied or revoked, pursuant to section 96C(4) of the Medicines Act 1981.
Dated this 5th day of November 2015.
Hon JONATHAN COLEMAN, Minister of Health.