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• I. LAWS

  - Rwanda FDA Law

  - Law relating to the regulation and inspection of food and pharmaceutical products

  II. REGULATIONS

  - Rwanda FDA’s Regulations governing Clinical Trials in Rwanda: For regulation, approval and inspection of clinical trials

  - Rwanda FDA’s Regulations governing Pharmacovigilance in Rwanda

  - Regulation Governing control of import – export of pharmaceutical products and medical devices

  - Rwanda FDA’s Regulations governing Registration of Medicinal Products

  - Rwanda FDA’s Regulations governing Registration of Medical Devices

  - Rwanda FDA’s Regulations Related to Regulatory Services Tariff/fees and fines

  - Rules and Regulations for Research Activities in Rwanda

  - Rwanda FDA’s Clinical Trials Requirements

  III. PRESIDENTIAL /MINISTERIAL ORDERS OR INSTRUCTIONS

  - Presidential order on food supplements Regulation in Rwanda

  - Ministerial Order Nº 002/17/10/Tc of 27/10/2017 Determining the Fees for Other Related Services Products, Medical Devices and Registration Of Pharmaceutical Products, Medical Devices And Other Related Services

  - Ministerial instructions no 003/2010 of 09/12/2010 regulating research activities in Rwanda

  - Ministerial Order nº 20/37 of 30/10/2015 determining the code of ethics for pharmacy profession. (O.G n°48 of 30/11/2015)

  IV. POLICIES

  - Health Sector Policy

  - Science, Technology and Innovation Policy (NCST - 2020)

  - Pharmacy Policy Rwanda

  - Policy of Traditional Complementary Alternative Medicine

  V. GUIDELINES

  - RNEC Standard Operating Procedures

  - National Health Research Committee (NHRC) Review Checklist

  - Health Systems Operational Research Challenge Fund Implementation guidelines

  - NISR VISA - Procedures of Visa application to conduct any statistical survey in Rwanda