Tajikistan Medical Device Clinical Trials: Approval and Conduct Requirements

1. Key takeaways

Clinical trials in Tajikistan are approved by the Ministry of Health, conducted within health institutions designated by the Ministry, and led by authorized physicians with adequate qualifications. Article 34 of Law No. 1893 contains 10 paragraphs covering purpose, approval, the document list, trial sites, investigator qualifications, adverse reaction reporting, submission of results, procedure-making, funding sources and a dedicated procedure for medical devices. GRZAN highlights three key constraints. First, the decision to conduct a clinical trial is made by the Ministry of Health on the basis of the written consent of citizens, taking into account the conclusions and submissions of the supervisory authority under Article 34(2). Second, the investigator must immediately notify the Ministry of Health when adverse reactions occur under Article 34(6). Third, patient participation must be voluntary and supported by written consent under Article 35(1) and Article 35(2).

2. Legal basis

3. Expert insights

Insight 1: Article 34(2) makes the written consent of citizens a precondition of approval, which is uncommon in comparative terms. The provision requires the Ministry of Health to make its decision on the basis of citizens’ written consent, together with the conclusions and submissions of the supervisory authority. This structure elevates subject consent from an ethical requirement to an element of administrative approval. GRZAN handles this in practice by submitting the informed consent documents as part of the approval application package, rather than leaving them to be signed before trial initiation. Filing them early also gives reviewers a chance to comment on the consent wording before the trial design is locked.

Insight 2: the immediate notification of Article 34(6) is the only time-related wording, and it specifies no hours. The provision requires the investigator to notify the Ministry of Health immediately when adverse reactions occur. GRZAN does not adopt the circulating claim of reporting serious adverse events within 72 hours: neither Article 34(6) nor Article 20(3) sets any specific number of hours, and any concrete reporting deadline must await normative documents of the Ministry of Health. Companies should design their SOPs around the literal requirement of immediacy, setting internal trigger mechanisms and internal deadlines measured in hours, rather than waiting for a statutory figure that does not yet exist.

Insight 3: Article 34(4) restricts trial sites to the list determined by the Ministry of Health. Companies cannot freely choose any hospital in Tajikistan for a trial; the site must come from the list. GRZAN recommends requesting that list at the project initiation stage and assessing in parallel the department capabilities and enrollment potential of the listed institutions, because both factors directly affect trial design, feasibility and overall duration.

Insight 4: Article 34(8) and Article 34(10) separate the procedure-making powers. Paragraph 8 covers medicines and parapharmaceuticals, while paragraph 10 covers clinical trials and clinical and laboratory verification of medical devices. This separation mirrors the structure of Article 17(10) and Article 17(12) and confirms again that the legislature deliberately splits device procedures from medicine procedures. When requesting procedural documents, companies should ask explicitly for the version applicable to medical devices.

Insight 5: Article 34(9) allows trial funding from interested parties. The provision expressly permits funding from the state budget, from interested natural or legal persons, and from other sources not prohibited by law, which gives sponsor-funded trials a legal basis. At the same time, Article 19(3) requires that members of the ethics review committee not be dependent on manufacturers and developers of medicines or other interested parties, showing a deliberate counterweight between funding and the independence of ethical judgment.

4. Practical recommendations

1. Include the informed consent documents in the approval application. Under Article 34(2), GRZAN recommends submitting the informed consent template together with the approval application and discussing the template content with the Ministry of Health in advance.
2. Design internal SOPs around immediacy, not around a statutory hour count that does not exist. Set internal reporting deadlines in hours and define the internal criteria and responsible persons for what counts as an adverse reaction.
3. Request the trial site list at project initiation. Under Article 34(4), obtain the currently valid list of health institutions from the Ministry of Health and assess the department match of each listed institution.
4. Request the procedural documents applicable to medical devices. Under Article 34(10), obtain the procedure for clinical trials and clinical and laboratory verification of medical devices, not the medicines version under paragraph 8.
5. Implement all six information items of Article 35(3) fully. The informed consent form should cover, item by item, the essence of the product and the trial, side effects, expected effectiveness and safety, the degree of risk, measures for unexpected effects and insurance conditions; missing items become obstacles in ethics review and approval.

5. Verification checklist

• □ Confirmed that the decision to conduct the trial is made by the Ministry of Health under Article 34(2)
• □ Included the informed consent documents in the approval application package
• □ Obtained the currently valid trial site list from the Ministry of Health under Article 34(4)
• □ Confirmed that the physician leading the trial holds the required authorization under Article 34(5)
• □ Set the internal adverse reaction reporting SOP and responsible persons around the immediacy requirement of Article 34(6)
• □ Obtained the procedural documents for clinical trials applicable to medical devices under Article 34(10)
• □ Confirmed that the informed consent form covers all six information items of Article 35(3)

Regulatory information verified as of October 29, 2026.

In the Central Asian market, the core capabilities of GRZAN concentrate on three areas. First, distinguishing the different legal positions of each market within the Eurasian Economic Union: Kazakhstan and Kyrgyzstan are full member states where a dual-track choice exists between the national route and the Union route; Uzbekistan is an observer state with only a national route; Tajikistan and Turkmenistan sit outside the Union framework and must follow purely national procedures. Second, local authorized representative services: GRZAN acts as the statutory representative of manufacturers in these countries and undertakes registration submissions, regulatory communication and post-market reporting obligations. Third, quality system and testing support: GRZAN helps establish a quality management system conforming to ISO 13485 and connects clients with locally accredited laboratory resources.

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