- Guideline for Registration of Transfusion Transmissible Infections(TTI) test kits
- Guideline for registration of Biotechnology Products for Human use
- Guideline on Pharmacoviglance for Traditional Medicines-Dzongkha version
- Medical Device Strategy
- Guideline for Advertisement of Medicinal Products
- Guideline on Pharmacoviglance for Traditional English-version
- Guideline on Pharmacoviglance for Veterinary centres
- Blood and Blood Products Regulation of Bhutan 2016
- National Standards for Blood Transfusion Services
- Guideline for disposal of Pharmaceutical Waste
- Guideline for Registration of Biotechnology Products for Veterinary Use
- Guideline for Registration of API
- Inspection Guideline
- Application, Registration fees and Renewal fees
- Conditions & Documents for ER Registration of Medicinal products
- Guidance document on Technical Authorization for Manufacture and Regulatory Certifications
- Bhutan National Formulary for Traditional Medicines 2019
- Bhutan National Formulary 2019
- Guideline for Management and Handling of Defective Medical Products, 2019
- Sampling Guideline for Pharmaceutical Products and Related Materials, 2019
- Guidelines for Good Manufacturing Practices of Medical Gases
- Guideline for Regulating Health Supplements
- Guidelines for Regulating Human Vaccines
- Addendum 2021: Guideline for Registration of Medicinal Products 2020
- Guideline for Import, Sale, Distribution and Use of COVID-19 Self-Test Kits 2022