Regulating Medicines

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Regulating Medicines
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Medicines Development
10,000 substances
Eureka
Pre-Clinical Investigation Animal
toxicology Animal pharmacokinetics/ pharmacodynami
cs
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
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Why regulate Medicines?

• Assurance of
• Quality (stability, purity)
• Safety
• Efficacy
• Need to update information
• Pharmacovigilance

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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

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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
  devices to maximise safety and benefit.

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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

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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

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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

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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

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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

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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

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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.

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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

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Post-Marketing Activities

• Medicines testing programme
• Compliance monitoring
• Complaints investigation
• Pharmacovigilance (adverse reactions monitoring)
• Publications
• Regulatory action

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Compliance Activities

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

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Access to Medicines

• Medicines Classification Committee
• Prescription medicines
• Restricted medicines
• Pharmacy-only medicines
• General sales medicines

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Issues considered in reclassification

• Toxicity
• Abuse Potential
• Inappropriate use
• Precautions
• Communal Harm

• Convenience
• Potency
• Current Availability
• Therapeutic Index