STAKEHOLDERS MEETING TO DISCUSS GUIDELINE FOR SUBMISSION OF DOCUMENTATION FOR REGISTRATION OF HUMAN

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STAKEHOLDERS MEETING TO DISCUSS GUIDELINE FOR
SUBMISSION OF DOCUMENTATION FOR REGISTRATION OF
HUMAN MEDICINAL PRODUCTSLand Mark Hotel15 May
2008

• CLINICAL PART

Sophia Ally Drug Evaluation officer Tanzania
Food and Drugs Authority
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contents

• Introduction
• Guidelines
• Bioequivalence study report
• Biowaver
• Safety and efficacy data for new chemical
  entities

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Introduction

• Safety and Efficacy of Medicine
• Full non clinical and clinical data
• New chemical entities
• Reference Current ICH Guideline
• Bioequivalence data - Generic products

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Introduction

• The bulk of medicinal product in Tanzanian market
  are Generic.
• Emphasis of the Guidelines is on the product
• Presentation is on the safety and efficacy data
  on the generic medicine -Bioequivalence

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Guidelines for BE Studies

• Reference to WHO guidelines on registration
  requirements to establish interchangeability (WHO
  Technical Report Series, No. 937, 2006, Annex
  7)
• http//www.who.int/medicines/publications/pharmpr
  ep/TRS_937.pdf
• BE Data to be presented in the application
  form-annex 2

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Clinical study report (BE)

• Data about preparations used
• Description of the study design
• Characterization of study subjects

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Clinical study report (BE)

• Description of study procedures
• Description and validation of drug determination
  methods in investigated material.
• Sensitivity
• - Precision
• repeatability
• - Accuracy
• Specificity

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Clinical study report (BE)

• Calculation methodology of pharmacokinetic
  parameters
• Description of statistical methodology and
  results of statistical calculations

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Clinical study report (BE)

• Quality assurance of the study
• Description of quality assurance methods
• Monitoring, auditing, inspections
• Conclusions

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Biowaver

• Biowaiver is a regulatory drug approval process
  when the dossier (application) is approved based
  on evidence of equivalence other than through in
  vivo equivalence testing
• Reference Proposal to waive in vivo
  bioequivalence requirements for WHO Model List of
  Essential Medicines immediate-release, solid oral
  dosage forms".
• (WHO Technical Report Series, No. 937, 2006
  Annex 8)
• http//www.who.int/medicines/publications/pharmpr
  ep/TRS_937.pdf

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Criteria for biowaiver

• Biopharmaceutical classification system (BCS )
• Highly solubility
• dose/solubility ratio of less than 250ml
  at 37?C,over Ph range of 1.2-6.8
• High permeability
• absorption to extent of 85 or more

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Criteria for biowaiver

• Risk
• Benefit/risk analysis
• Pharmaceutical form
• (aqueous solutions)
• Solutions for oral use
• Parenteral
• Opthalmic
• Locally acting
• Nebulizer inhalation or nasal sprays

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Criteria for biowaiver

• Powders for reconstitution as a solution
• Gases

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Unsuitable scenarios for BE

• Comparative Pharmacodynamic studies
• - Dose-response relationship
• - Measurement to provide PD response profile
• - Validation of Pharmacodynamic
  measurements/Method
• Comparative clinical studies

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BE Data for Fixed dose combination product

• BE for individual components

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New chemical entitities

• ICH guidelines
• Safety S1-8
• Efficacy E1-12
• Available free of charge online at www.ich.org

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Thank you