Registration and licensing directorate

Ensure the safety, efficiency and quality of medicine so as to authorize their use in the country and to ban those medicines which are unsafe, poor qulity abnd ineffective. In addition, food safety and quality will be ensured. It authorizes conduting clinical trial, monitor the process, evaluate the results and atuthorize the use of the result in such a way that it benefits the public; as well as cause to suspend or stop the clinical trial.

Activities performed under this Directorate are as follows:

  1. Food and medicine market authorization
  2. Issuance of certificates of competency to medical representatives
  3. Medical promotion material evaluation
  4. Clinical Trial Authorization and Monitoring
  • Foreign manufacturer GMP inspection team

Evaluate dossier, conduct GMP inspection on foreign manufacturer to authorize safe, effective and qualifty product to be used in the country and available in the market. Issue certificate of competency to medical representatives, evaluate Medicine promotion material, authorize and monitor clinical trial

  • Local manufacturer GMP inspection team

Evaluate dossier, conduct GMP inspection on local manufacturers to authorize safe, effective and quality to be used in the country and available market. Issue certificate of competency to medical representatives, evaluate medicine promotional material, authorize and monitor clinical trial. In addition, the team will perform consultative inspection and provide necessary standards from designing and construction to production for local manufacturers.

Checklists and Formats

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