Eureka
Pre-Clinical InvestigationAnimal toxicology
Animal pharmacokinetics/pharmacodynamics
Clinical InvestigationPhase I Safety and pharmacology
Phase II EfficacyPhase III Safety and Efficacy
Marketing ApprovalPhase IV
17 years and 800 million US dollars
Medicines Development
3,000 patient/years exposure
10,000substances
1 product
Why regulate Medicines?
Assurance of:
• Quality (stability, purity)
• Safety
• Efficacy
• Need to update information
• Pharmacovigilance
Regulation of Medicines
Key activities:• Control of the manufacturing chain
• Control of the distribution chain
• Pre-market evaluation and approval
• Post-market surveillance
• Control of access to medicines
FDA TGA In NZ Medsafe: New Zealand Medicines and
Medical Devices Safety Authority Medsafe's mission is
To enhance the health of New Zealandersby regulating medicines and medical devices to maximise safety and benefit.
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
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
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
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
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
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
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.
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
• 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
• Prescription medicines
• Restricted medicines
• Pharmacy-only medicines
• General sales medicines