| Guideline for Registration of Medicinal Products 2020 |
| Addendum 2021: Guideline for Registration of Medicinal Products 2020 |
| Guideline for Registration of Medical Devices 2022 |
| Guideline for Importation of Medicinal Products and Health Supplements |
| Guideline for Regulating Human Vaccines |
Guideline for Cancellation, Suspension and Withdrawal of Market Authorisation of Medical Products, 2023
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Pharmacovigilance Guide for Adverse Drug Reaction Monitoring And Causality Assessment, 2017
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| Guideline for Regulating Health Supplements |
| Interim Guideline for Regulating Face mask |
| Guideline for Import, Sale, Distribution and Use of COVID-19 Self-Test Kits 2022 |
| Inspection Guideline, 2018 |
| Guideline for Registration of Biotechnology Products for Human Use |
| Interim Guideline for Import of Hand Sanitizers |
| Guideline on Pharmacovigilance for Traditional Medicines Dzongkha Version |
| Guideline on Pharmacovigilance for Traditional Medicines English Version |
| Guideline for Advertisement of Medicinal Products |
| Guideline on Pharmacovigilance for Veterinary Centers |
| Guideline for Disposal of Medical Product Waste |
| Guideline for Registration of Biotechnology Products for Veterinary Use |
| Guideline for Registration of API |
| Guidance document on Technical Authorization for Manufacture and Regulatory Certifications |
| 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 |
