REGULATORY INFORMATION

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Medicines Assessment Advisory Committee

Administrative processes of the Medicines Assessment Advisory Committee

The Medicines Assessment Advisory Committee (MAAC) process consists of the following 6 steps:

1. A new medicine application is received by Medsafe or a changed medicine notification is referred to the Minister under section 24(5) of the Medicines Act 1981.
2. The application is assigned to evaluators for assessment of the clinical and pharmaceutical chemistry data.
3. Evaluation is undertaken, issues resolved if possible, and an evaluation report prepared.
4. Based on the evaluation Medsafe either makes a recommendation to the Minister's delegate to grant consent OR to refer the application under section 22(2) of the Medicines Act 1981, to the MAAC for further advice.
5. The MAAC considers applications referred to it and makes a recommendation to the Minister's delegate on whether or not consent should be granted.
6. The Minister's delegate makes a decision on whether to grant or refuse to grant consent to distribute the new medicine.

Key features of the MAAC process:

• The pharmaceutical chemistry and clinical assessment of a New Medicine Application or Changed Medicine Notification referred under section 24(5) of the Medicines Act 1981 will commence as soon as feasible after an application is received by Medsafe.
   
• Once initial evaluation is completed, further information will be requested from the applicant to resolve any issues that have arisen during evaluation. A copy of the evaluation report will be provided to the applicant.
  
  Up to two requests for further information may be made in an attempt to resolve any outstanding clinical or pharmaceutical chemistry issues before the evaluation report is finalised.
   
• Based on the finalised evaluation report, Medsafe will either make a recommendation to the Minister's delegate to grant consent or that consent cannot be recommeded.
   
• In deciding whether to recommend that consent is granted, Medsafe will take into account recommendations made by the evaluator and other factors such as the nature of the medicine, the quality of the data submitted, the conclusions reached by the evaluator and whether the medicine has been approved by other regulatory authorities.
   
• Where Medsafe's recommendation is to grant consent and the Minister's delegate accepts this recommendation, the consent process will proceed without the application being referred to the MAAC.
   
• Where Medsafe is not able to recommend to the Minister's delegate that consent is granted, the application will be referred to the MAAC. Applications are referred to the MAAC when Medsafe is unsure whether to recommend consent, other regulators differ in their approvals, or the application is a world first new chemical entity.
   
• The MAAC meeting agenda will be finalised one month prior to the date of the meeting. The applicant will be notified of the MAAC meeting date and that their application has been placed on the MAAC agenda.
   
• The MAAC will make a recommendation to the Minister's delegate whether to grant or refuse to grant consent. The final decision rests with the Minister's delegate and process is appealable under section 22(4) of the Medicines Act 1981.
   
• Applications may be withdrawn from the MAAC process at any time.

Any correspondence regarding the MAAC should be addressed to the:

Secretary
Medicines Assessment Advisory Committee
Medsafe
PO Box 5013
Wellington 6145