133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T +64 4 496 2000
W www.medsafe.govt.nz
26 November 2021
Matthew Hooton
By email: [FYI request #17402 email]
Ref:
H2020115478
Dear Mat hew
Response to your request for official information
Thank you for your request under the Official Information Act 1982 (the Act) to the Ministry of
Health (the Ministry) on 30 October 2021. You specifically requested:
“...any medicines, in the last five years, that you have turned down for use in New Zealand
after they had been approved for use in the USA by the FDA.”
The following new medicine applications were either refused approval or withdrawn by the
sponsor following referral by Medsafe to the Medicines Assessment Advisory Commit ee under
section 22(2) of the Medicines Act 1981 during this period. More information about these
applications is available at:
www.medsafe.govt.nz/regulatory/DbSearch.asp.
Medicine
Status
Lidocaine (B.Braun)
Refused
Nasovac-S
Withdrawn
Heberprot-P
Withdrawn
Liposomal Doxorubicin SUN Withdrawn
Azmasol HFA Aerosol
Withdrawn
Diclofenac Mylan
Withdrawn
Travoprost-multichem
Withdrawn
Clonazepam BNM
Withdrawn
Iberogast
Withdrawn
Medsafe does not hold information on the approval status of medicines in other jurisdictions.
Therefore, your request for information on the approval status of these applications in the USA is
refused under section 18(g)(i) of the Act, as the information requested is not held by the Ministry
and there are no grounds for believing it is held by another agency subject to the Act.
Further information
Applications for consent to distribute a new medicine may be referred to the MAAC committed by
the Minister of Health under section 22(2) of the Medicines Act 1981, if he is not satisfied that he
should give his consent to the distribution of the medicine. This includes medicines that have
undergone full evaluation and where there remain outstanding questions regarding the safety,
efficacy, or quality of the medicine. Applicants may choose to withdraw their medicine application
at any time during the consent process, and it is common that applicants withdraw their
applications prior to them being referred to the MAAC.
Medsafe has an abbreviated evaluation pathway in which review of overseas regulatory
evaluation reports forms the basis of our evaluation. The abbreviated evaluation pathway has
shorter evaluation timeframes and reduce costs to applicants. Medsafe is considered a leader in
reliance pathways for medicine applications as we have had abbreviated pathway in place for
more than a decade.
Medsafe approval of medicines helps to ensure that medicines approved for supply within New
Zealanders are suitable and appropriate. For example, it may take into account other medicines
that are commonly used in New Zealand, the way in which dif erent medicines are used in New
Zealand, and proposed supply chain for New Zealand. Medsafe’s independent premarket
evaluation helps to manage the risk of medicines and provides the public assurance that
approved medicines are of acceptable efficacy, safety and quality.
Note that although medicines may have similar ‘brand names’ in various jurisdictions and are
mostly the same, the exact nature of the medicine can dif er depending on where it is supplied.
This can include for example sites or manufacture and testing, release specifications, indications
and contraindications, warning statements, shelf life.
It is also important to note there are dif erence in medicines legislation employed by various
international regulators. For example, the US FDA has the ability to grant ‘Emergency Use
Authorisation’ for medicines, and did so with the Pfizer COVID-19 vaccine, Comirnaty, in
December 2020. This allowed the FDA to authorise use of Comirnaty based on a review of the
very limited data available at the time and make a decision based on the benefit of the vaccine
weighed up against the risk to public of the COVID-19 outbreak in the USA at the time. The FDA
later approved Comirnaty following a full evaluation, in August 2021. Medsafe used our
provisional consent pathway to grant approval of Comirnaty with conditions imposed in February
2021.
Medsafe pre-market evaluation of medicines also ensures that we have ready access to technical
information and are able to understand and respond to post-market issues promptly. This
includes for example assessment of adverse event reports, investigation of suspected product
quality issues, and overseeing market recalls. Data reviewed during premarket evaluation is
critical to these post market functions. The New Zealand public has a high expectation that
Medsafe is able to effectively manage such risks.
I trust this information fulfils your request. Under section 28(3) of the Act, you have the right to
ask the Ombudsman to review any decisions made under this request. The Ombudsman may be
contacted by email at:
[email address] or by calling 0800 802 602.
Please note that this response, with your personal details removed, may be published on the
Ministry website at:
www.health.govt.nz/about-ministry/information-releases/responses-official-
information-act-requests.
Yours sincerely
Chris James
Group Manager
Medsafe
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