Eureka Pre-Clinical Investigation Animal toxicology Animal pharmacokinetics/ pharmacodynamics Clinical Investigation Phase I Safety and pharmacology Phase.

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

Issues considered in reclassification:

• Toxicity

• Abuse Potential

• Inappropriate use

• Precautions

• Communal Harm

• Convenience

• Potency

• Current Availability

• Therapeutic Index