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

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.  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.

6.  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.  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.  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.  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.  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.  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.  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.  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