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Committees

Revised: 30 January 2015

Medicines Assessment Advisory  Committee

Agenda for the 101st meeting of the Medicines Assessment Advisory Committee to be held at the Rydges Wellington, 75 Featherston Street, Pipitea, Wellington 6011 on Tuesday 10 March 2015 at 9:30 am

1

Welcome and Introductions

A brief overview of Medsafe, the medicine evaluation process and the role of the Committee will be provided for the two new members.

2

Apologies

3

Confirmation of the minutes of the 100th meeting held on Tuesday 30 September 2014

4

Declaration of conflicts of interest

5

Matters arising

5.1

Prochymal (remestemcel-L) 100 million cells in 15 mL solution for injection (TT50-8843)

CARSL Consulting

At the 99th meeting on 1 July 2014, the Committee recommended that if the medicine Prochymal was not used in New Zealand over the next two years its approval should lapse when the provisional consent expires on 14 June 2016.

Medsafe met with CARSL Consulting following this recommendation. The Committee will be provided with an update on this meeting.

5.2

Relvar Ellipta (fluticasone fluorate and vilanterol trifenatate) 100 mcg/25 mcg and 200 mcg/25 mcg powder for inhalation (TT50-9114,a)

GlaxoSmithKline (NZ) Limited

At the 100th meeting on 30 September 2014, following a review of the evaluation, the Committee recommended that Medsafe should provide a response to the questions posed by the reviewer at a future meeting.

The Committee will be provided with an update on the progress of Medsafe's response.

6

Applications for consent to distribute a new medicine under section 20 of the Medicines Act 1981 (referred by the Minister of Health under section 22(2))

6.1

Tresivac MMR vaccine, powder for injection with diluent (TT50-9138)

Te Arai BioFarma Limited

Tresivac is a MMR vaccine containing live measles, mumps and rubella viruses. The measles and mumps virus strains used differ from those products currently registered in New Zealand. Vaccination with a MMR vaccine forms part of the New Zealand immunisation schedule at age 15 months and four years.

The application has undergone two rounds of 'Requests for Information' in accordance with Medsafe's standard evaluation processes and many issues remain unresolved. Medsafe is unable to recommend that the benefits of using the medicine Tresivac in the prevention of MMR outweigh the risk presented by these unresolved issues.

The application is being referred to the Committee for independent advice as to whether the Minister of Health should grant consent.

7

Review of evaluation reports

7.1

List of medicines for potential review in 2015

The Committee will be provided with a list of all medicines of which evaluations were concluded in 2014.

The Committee will discuss which medicines should be reviewed (a maximum of eight will be chosen) and by which member of the Committee. Completed reviews will be brought back to the next meetings in June and September 2015.

8

General business

8.1

New Zealand's domestic regulatory reform

An update will be provided following the announcement that the Australian and New Zealand Governments have agreed to cease efforts to establish a joint therapeutic products regulator (the Australia New Zealand Therapeutic Products Agency (ANZTPA)).

8.2

Any other business

9

Date of next meeting

 

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