Download How A Medicine Reaches The NZ Market

Medicines
Development
Eureka
10,000
substances
Pre-Clinical Investigation
Animal toxicology
Animal pharmacokinetics/
pharmacodynamics
Clinical Investigation
Phase I Safety and pharmacology
Phase II Efficacy
Phase III Safety and Efficacy
Marketing Approval
Phase IV
17 years and 800 million US dollars
3,000 patient/years exposure
1
product
Why regulate Medicines?
Assurance of:
• Quality (stability, purity)
• Safety
• Efficacy
• Need to update information
• Pharmacovigilance
Regulation of Medicines
Key activities:
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Control of the manufacturing chain
Control of the distribution chain
Pre-market evaluation and approval
Post-market surveillance
Control of access to medicines
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FDA
TGA
In NZ Medsafe: New Zealand Medicines and
Medical Devices Safety Authority
Medsafe's mission is
To enhance the health of New Zealanders
by regulating medicines and medical devices
to maximise safety and benefit.
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Evaluate applications from manufactures
wishing to market a new medicine
Approve clinical trials on new medicines
Monitor the safety of medicines and medical
devices
Issue licences to importers and distributors of
medicines
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Rules on manufacturing and purity of
medicines
Animal data required before human studies
can be approved
Levels of safety and efficacy required for
approval for marketing
Claims that can be made in medicines
advertising
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Part of the approval process consists of
writing a ‘drug label’
Contains data on the pharmacological
actions, approved use, side effects and
dosing of the drug for prescribers.
Content of the label is defined by law
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A clinical trial is defined as any research on
human subjects conducted to gain new
knowledge into mental and physical health
and disease.
Involve a wide range of health professionals
and are usually conducted in hospitals, the
community or academic institutions.
Divided into 5 distinct phases
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Phase I - evaluation in volunteers - fate of
drug in body and safety profile
Phase II - initial studies in patients – proof of
concept and dose ranging
Phase III – pivotal proof of effectiveness and
safety. Multicentre.Controlled.
Phase IV-comparative trials
Phase 5-new indications
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Through the Ministry of Health
Applications assessed by the Health Research
Council Standing Committee of Therapeutic
Trials (SCOTT)
Requires submission of all preclinical and
clinical data and clinical trial protocol
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Requirements for the approval to market a
medicine in New Zealand are set out in the
Medicines Act 1981 and Regulations 84.
Approval granted by the Minister of Health on
advice from the ministry through Medsafe a
business unit of the Ministry of Health.
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Evaluate applications from manufactures
wishing to market a new medicine
Approve clinical trials on new medicines
Monitor the safety of medicines and medical
devices
Issue licences to importers and distributors of
medicines
Post-Marketing Activities
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Medicines testing programme
Compliance monitoring
Complaints investigation
Pharmacovigilance (adverse reactions
monitoring)
• Publications
• Regulatory action
Compliance Activities
• Good manufacturing practice (GMP)
audits
• Recalls and complaints
• Medicines testing
• Medicines device monitoring
• Licencing activities
– Wholesalers licence
– Pharmacy licence
– Importing licence
Access to Medicines
Medicines Classification Committee
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Prescription medicines
Restricted medicines
Pharmacy-only medicines
General sales medicines
Issues considered in
reclassification:
• Toxicity
• Abuse Potential
• Inappropriate
use
• Precautions
• Communal
Harm
• Convenience
• Potency
• Current
Availability
• Therapeutic
Index