Overview of the Guidelines on Submission of Documentation for Registration of Human Medicinal Produc

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Overview of the Guidelines on Submission of
Documentation for Registration of Human Medicinal
Products in Tanzania

• Hiiti Sillo
• Acting Director
• Medicines and Cosmetics TFDA
• LandMark Hotel, Dar es Salaam
• 15th May 2008

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Background

• Why guidelines for registration of medicines
• To facilitate applicants to provide in a uniform
  manner in terms of content and format evidence
  that
• Medicines seeking registration demonstrate
  consistence in terms of manufacturing process and
  quality control
• Competent authorities can be prove quality,
  safety and efficacy though evaluation of
  documentation
• Not intended to inhibit innovation variations
  post registration are accepted
• Marketing Authorization/Drug Registration/Product
  License issued as evidence after satisfactory
  evaluation

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Why Review the Current Guidelines

• Operational since June 2004
• Almost 5 years now
• Many changes have occurred during this period
• Changes in Bioequivalence requirements e.g.
  Biowaivers
• Lack of guidance on variations/alterations
• The guidelines were oversummarised

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The Review Process

• Key references
• Current edition (June 2004)
• WHO Prequalification Guidelines
• ICH guidelines especially for new drug molecules
• The process
• Review by TFDA drug evaluators
• Inputs internal technical committee
• Stakeholders comments
• Approval by TFDA Management
• Publication hard copies on website
• Transitional arrangements implementation

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Outline of the Guidelines

• Administrative Data
• Summary of Product Characteristics
• Active Pharmaceutical Ingredients
• Finished Pharmaceutical Products
• Interchangeability/Bioequivalence
• Pharmacology, Toxicology and Efficacy of New
  Drugs
• Fixed Dose Combination Products
• Guidelines for Variations/Alterations
• Annexes

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Expectations

• Consistent and uniform documentation of
  submissions
• Efficient and effective evaluation
• Evidence based registration

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Applicability

• Human Medicinal Products
• Domestic pharmaceutical manufacturers
• Foreign pharmaceutical manufacturers
• Implementation from July 2008 with transitional
  arrangements

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By the End of Day Today
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THANK YOU VERY MUCH