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Regulating Medicines

Learn about the importance of regulating medicines, including the need for quality, safety, and efficacy assurance. Explore the key activities involved in regulation, such as manufacturing and distribution control, pre-market evaluation and approval, and post-market surveillance. Discover the role of regulatory bodies like FDA, TGA, and Medsafe in ensuring the health and well-being of patients. Gain insights into clinical trials, drug labeling, and the process of new drug approval in New Zealand. Also, explore post-marketing activities, compliance monitoring, pharmacovigilance, and access to medicines.

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Regulating Medicines

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  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

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