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
- Traditional medicines
- Complementary and alternative medicines
- Medical supplies and instruments
- Food including Food supplement and infant formula
- Sanitary items
- Raw and packaging materials
Institutions Regulated by FMHACA
- Importers and wholesalers
- Drug quality control Labs
- Scientific offices
- Specialized Hospitals
- Speciality Centers