National Medicines Regulatory Authority (NMRA)

Medicines Regulatory Division

• Guideline on Registration of Medicines

• Guidelines on Evaluation of Similar Bio therapeutic Products (SBPs)

• Biosimilars_EU-guide_2017

• Route of Administration

• Guidelines for Handling and Storage of Vaccines in the Private Sector

• Guideline for safe Disposal of Expired & Unwanted pharmaceuticals
• Guideline on Import control 
• Guideline on Advertising of Medicines & Medicinal Products to General Public
• Guideline on submitting registration sample to NMQAL
• Guideline on Labeling of Medicines
• Guideline on Variations for Medicines 
• Guideline on Post Marketing Surveillance
• Guideline on Registration of Vaccines
• Guideline on Importing Medicines for Personal Use

Medical Device Regulatory Division

• Guidelines for registration of Medical Devices

• Guideline on Import control
• Guideline for safe Disposal of Expired & Unwanted pharmaceuticals
• Guideline on submitting registration sample to NMQAL

Borderline Products Regulatory Division

• Approved iodine guideline

• Guidelines on product categorization reference details vitamins and elements

• Guideline on Import control
• Guideline for safe Disposal of Expired & Unwanted pharmaceuticals
• Guideline on submitting registration sample to NMQAL

Pharmacies Regulatory Division

• Guideline on Good Pharmacy Practice 

• Guideline on Good Distribution Practice 

• Guideline for Good Storage Practices for Pharmaceuticals 

• Guidelines for Community Pharmacy Practice

Clinical Trials Regulatory Division

• Guidelines for the recognition of Ethics Review Committees

• Ethics Review Committee Guidelines - FERCSL

• Guidelines for the Conduct of Clinical Trials in Sri Lanka

• Guideline for Good Clinical Practice- ICH

Cosmetic Regulatory Division

• Guidelines for registration of cosmetics in Sri lanka

Manufacturing Regulatory Division

• Guideline on Approval of an Overseas Manufacturing Plant of Medicines

• Guideline on Preparation of Site Master Files
• Guideline on Good Manufacturing Practice
• Guideline for preparation and conduct of the GMP inspection

Pharmacovigilance Regulatory Division

•  Guideline on Complaints

• Guideline on Pharmacovigilance
• Guideline on Recall of Medicines, Medical Devices & Borderline products
• Guideline on Rapid Alert System

Education and Publication Regulatory Division

• Guideline on Education & Training for staff of NMRA

• General Guidelines

  • Guideline on Complaints 

  • Guideline for the Waivers of Registration (WOR) 

  • Guideline on Transfer of Market Authorization Holder 

  • Guidelines for the recognition of Ethics Review Committees