1. Regulating Medicines

2. Medicines Development 10,000 substances Eureka 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 1 product 3,000 patient/years exposure

3. Why regulate Medicines? • Assurance of: • Quality (stability, purity) • Safety • Efficacy • Need to update information • Pharmacovigilance

4. 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

5. Who Regulates • FDA • TGA • In NZ Medsafe: New Zealand Medicines and Medical Devices Safety Authority • Medsafe's mission isTo enhance the health of New Zealandersby regulating medicines and medical devicesto maximise safety and benefit.

6. Medsafe Functions • 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

7. What do Regulations Define? • 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

8. Regulations on Labeling • 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

9. Clinical Trials • 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

10. Phases of Clinical Trials • 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

11. Approval of a Clinical Trial • 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

12. Regulations for New Drug Approval in NZ • 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.

13. Medsafe Functions • 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

14. Post-Marketing Activities • Medicines testing programme • Compliance monitoring • Complaints investigation • Pharmacovigilance (adverse reactions monitoring) • Publications • Regulatory action

15. Compliance Activities • Good manufacturing practice (GMP) audits • Recalls and complaints • Medicines testing • Medicines device monitoring • Licencing activities • Wholesalers licence • Pharmacy licence • Importing licence

16. Access to Medicines • Medicines Classification Committee • Prescription medicines • Restricted medicines • Pharmacy-only medicines • General sales medicines

17. Issues considered in reclassification: • Toxicity • Abuse Potential • Inappropriate use • Precautions • Communal Harm • Convenience • Potency • Current Availability • Therapeutic Index