I. Major Duties and Responsibilities

  • Sets standards of quality, safety and efficacy of drugs and ensure their observance.
  • Sets standards of competence and issues, controls, renews, revokes, suspends certificate of competence of drug establishments.
  • Evaluates and issues, renews, revokes and suspends drug registration certificate
  • Undertake inspection of pharmaceutical premises, establishments and port of entry and exit.
  • Prepares categories and revises national list of drugs.
  • Formulates police, and prepares draft legislation.
  • Control quality of raw and packing materials used for the production of drugs and finished products.
  • Prepares standards of quality, safety and efficacy of traditional drugs
  • Serves as drug information resource center and controls advertisement and promotion.
  • Control production, import, export, distribution and use of Narcotic drugs and Psychotropic substances.
  • Conduct and coordinate post marketing drug quality surveillance.
  • Issues license for conducting clinical trials, monitors and evaluates the process and authorizes the use of results.
  • Creates favorable conditions for the promotion and expansion of drug trade

II. Scope of Control

Products Regulated by FMHACA

  • Human Medicines
  • Radio-pharmaceuticals
  • Traditional medicines
  • Complementary and alternative medicines
  • Medical supplies and instruments
  • Food including Food supplement and infant formula
  • Sanitary items
  • Cosmetics
  • Raw and packaging materials

Institutions Regulated by FMHACA

  • Manufacturers
  • Importers and wholesalers
  • Exporters
  • Drug quality control Labs
  • Scientific offices
  • Specialized Hospitals
  • Speciality Centers

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