Published: 1 June 2017
Publications
The Medsafe Files — Episode Four: New Medicines Assessment (Part 1)
Prescriber Update 38(2): 27-28
June 2017
New Medicine Applications (NMAs)
Medicines and related products (see Section 2 of the Medicines Act 1981 [the Act] for definitions) need consent from the Minister of Health before being marketed in New Zealand. When seeking consent to distribute a new medicine, a New Medicine Application (NMA) must be submitted to Medsafe by the New Zealand sponsor. A new medicine is a medicine for which consent for distribution in New Zealand has not been granted or the approval has lapsed.
Medsafe also has an abbreviated evaluation procedure, which is based on a medicine’s approval by another recognised regulatory agency (eg, European Medicines Agency, Therapeutic Goods Administration of Australia, Health Canada). A review of overseas regulatory reports does not mean that the originator approval will be adopted in full by Medsafe. This evaluation process is not applicable to all medicine applications.
Applications can also be made for provisional consent (under Section 23 of the Act). Provisional consent is defined mainly by the clinical need. It is ideally suited to medicines still undergoing clinical development but where it is desirable that patients have early access. It is anticipated that the medicine will be used on a restricted basis for the treatment of a limited number of patients. Provisional consent is only granted for a period not exceeding two years and will then expire, unless the sponsor applies for a renewal.
Clinical Assessment
Supporting data must be included in an application to demonstrate the safety, efficacy and quality of the ingredients and the final product. The regulatory assessment of new medicines ideally follows pharmaceutical product development. Medsafe evaluators carry out pharmaceutical chemistry and clinical assessments.
If a pharmaceutical company wishes to sell or distribute a medicine in New Zealand, data from preclinical studies must be submitted as part of the application. Data includes:
- toxicity studies
- mutagenicity studies
- carcinogenicity studies
- single and repeated dose toxicity (in two species)
- first in human studies
- dose-ranging studies
- pivotal trials.
Parts 2 and 3 of Episode Four: New Medicines Assessment will cover pharmaceutical chemistry assessment and pharmaceutical Good Manufacturing Practice and will be included in upcoming editions of Prescriber Update.
Medicines Assessment Advisory Committee (MAAC)
After the evaluation of a NMA, Medsafe evaluators will make a recommendation on whether or not consent should be granted.
In instances when Medsafe is not able to recommend that consent is granted, applications can be referred to the Medicines Assessment Advisory Committee (MAAC). The MAAC has expertise in the safety, quality and efficacy of medicines and provides advice to the Minister of Health on the benefits and risks of new medicines.
Applications are referred to the MAAC in situations such as when:
- it is for a new vaccine indicated in children
- it is a novel technology such as medicines derived from stem cells and nanotech
- it is for a medicine that has been withdrawn or refused consent by a recognised regulator
- other regulators differ in their approvals
- it is a world first new chemical entity
- Medsafe is unsure whether to recommend consent.
Change Medicine Notifications (CMNs)
The sponsor of a product must notify the Director-General of Health of planned changes to an approved product. This type of application is called a Change Medicine Notification (CMN) and includes data sheet updates and package labelling updates for over-the-counter medicines. CMNs are assessed to ensure the change does not adversely affect the quality or benefit/risk balance of the medicine.
Some product changes such as additional indications, new sites of drug substance manufacture, failure to respond to requests for information or extensions to the current indication or dosing regimen require additional assessment by Medsafe. These applications may be referred to the Minister of Health under Section 24(5) of the Act when the proposed changes are of such a character or degree that the medicine should not be distributed without the consent of the Minister of Health. Consequently, CMNs referred under Section 24(5) typically have a longer processing time frame than a CMN.
Further information on application processes and the MAAC is outlined in Part 2 of the Guideline on the Regulation of Therapeutic Products in New Zealand (GRTPNZ) (www.medsafe.govt.nz/regulatory/Guideline/GRTPNZ/Part2.pdf).
