across the product lifespan TRUSTED to ensure the SAFETY and EFFICACY of all therapeutic products FLEXIBLE and RISK APPROPRIATE with enabling legislation framework to ensure therapeutic products are ACCESSIBLE ID: 914718
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Therapeutic Product Regulation
across the product lifespanTRUSTED to ensure the SAFETY and EFFICACY of all therapeutic productsFLEXIBLE and RISK APPROPRIATE with enabling legislation framework to ensure therapeutic products are ACCESSIBLE Consistent with INTERNATIONAL approaches, EFFICIENT and RESPONSIVE to support NZ ECONOMYA regulator with CAPABILITY , independence and ACCOUNTABILITY to make decisions that support safety and innovative health care solutions now and into the future
THERAPEUTIC PRODUCTSMedicines, medical devices and cells and tissue therapiesAim to treat or prevent ill health in humans
FOODNATURAL HEALTH PRODUCTSPSCYCHOACTIVE PRODUCTSCan NOT also be therapeutic productsCan NOT make therapeutic claimsMay be able to make health claims under specific rulesPerson bringing product to market will choose which regime to comply with according to how they want to position their product and compliance costs.Regulators will work together to ensure products are only regulated under one regime
CONTROLLED DRUGSMay also be therapeutic productsProcesses balance access to therapeutic products with risk of misuse and diversion
HEALTH PRACTITIONERSCompetence, registrations and scope of practice overseen by Responsible AuthoritiesScope of practice to now also include prescribing authorityNew prescribing authorities will be subject to consultation processes and approval by Minister of Health
HUMAN TISSUE
Will also be therapeutic products to enable oversight, particularly as technology develops
Human Tissue Act is concerned with consent to use donor tissue.
Organs for immediate transplantation will continue to be primarily governed by clinical decision-making to recognise their scarcity.
There are approx 7000 approved medicines
160 clinical trials approved each year
4500 suspected adverse reactions each year
50 million prescriptions each year
Medsafe
evaluates 200 new medicines and 1500 changes to medicines each year
There are approx 48,000 notified medical devices
980 audits of pharmacies each year
400 export certificates each year
HAZARDOUS SUBSTANCES AND NEW ORGANISMS
May also be therapeutic productsProcesses will be aligned and streamlined
Appendix 1: An overview of the objectives and context for therapeutic products regulation