Scope

  • National Organization for Research and Control of Biologicals (NORCB) is responsible for ensuring Safety, Quality and Efficacy of imported and domestic biological products and vaccines in compliance with the national and international standards.

  • NORCB is involved in :

  1. National regulatory system.
  2. Registration and marketing Authorization (MA).
  3. Vigilance.
  4. Marketing Surveillance and control.
  5. Regulatory Inspections.
  6. Laboratory Access & testing.
  7. Clinical Trials oversight.
  8. NRA lot release.

  • NORCB is the only responsible Organization for the Laboratory Access & testing functions for biological products and vaccines.

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