Tajikistan Ethics Review Council: Role in Medical Device Clinical Trials

1. Key takeaways

Ethics review in Tajikistan is carried out by the ethics review committee, whose charter and composition are developed and approved by the Ministry of Health. Article 19 of Law No. 1893 provides that ethics review is conducted by the ethics review committee in order to issue reasoned conclusions on clinical trials of medicines, medical devices and parapharmaceuticals; that the charter and the composition of the committee are developed and approved by the Ministry of Health; and that members may include representatives of medical, educational, scientific and other public organizations, while persons joining the committee must not be dependent on manufacturers and developers of medicines or other interested parties. GRZAN notes that although Article 19 contains only 3 paragraphs, it connects directly with the approval procedure of Article 34(2) and is a prerequisite stage on which the launch of any clinical trial depends.

2. Legal basis

3. Expert insights

Insight 1: Article 19(1) expressly includes medical devices within the scope of ethics review. The provision refers to clinical trials of medicines, medical devices and parapharmaceuticals. This means that device trials also pass through the ethics review committee; ethics review is not reserved for medicines. GRZAN schedules ethics review and the Ministry of Health approval under Article 34(2) as two sequential stages in every project plan, neither merged into the other nor omitted, because each produces a distinct document on which the next stage depends.

Insight 2: the independence requirement of Article 19(3) is drafted in rigid terms. The provision uses the formulation that persons joining the committee must not be dependent on manufacturers and developers of medicines or other interested parties. Read together with Article 34(9), which allows interested parties to fund trials, the counterweight designed by the legislature is visible: funding is permitted, but the funder must not influence ethical judgment. When cooperating with local institutions, companies should take care that no conflict of interest appears in the composition of the committee, because an objection on this ground can invalidate the review conclusion.

Insight 3: because the charter and composition are owned by the Ministry of Health, the operating rules of the committee are changeable. Article 19(2) grants the development and approval of the charter and composition to the Ministry of Health. GRZAN recommends requesting the currently valid committee charter before every ethics submission and checking whether the document list, the review cycle and, where applicable, the fee schedule still match previous experience, since a change of charter version can quietly alter the submission requirements.

Insight 4: Article 19 and Article 35 together form a two-layer structure of subject protection. Article 19 operates at the institutional layer, where the committee issues its conclusion, and Article 35 operates at the individual layer, guaranteeing voluntary participation, written consent, full information, the right to withdraw at any stage and written parental consent for minors. Article 35(6) further prohibits trials on certain categories of subjects. When designing the consent process, companies should satisfy both layers at once: the protocol must convince the committee, and the information must be genuinely understood by the subjects.

Insight 5: ethics review connects with the import exemption for trial samples. Article 17(4)(9) lists samples of medicines and medical devices used for preclinical and clinical research among the situations exempt from registration, and Article 26(8)(4) lists the conduct of preclinical and clinical trials among the exemptions from import and export restrictions. Taken together, the three provisions form a complete channel for trial samples: exemption from registration, exemption from import restrictions, and ethics review with approval. When preparing trial samples for import, companies should have all three legal bases ready at the same time.

4. Practical recommendations

1. Obtain the currently valid committee charter. Under Article 19(2), GRZAN recommends requesting the ethics review committee charter from the Ministry of Health before submission and checking the document list and review process against it.
2. Avoid conflicts of interest in cooperation agreements. Under Article 19(3), when contracting with local institutions and investigators, avoid situations where an investigator also sits on the committee, and state the independence requirement expressly in the agreement.
3. Schedule ethics review and Ministry approval as two stages. In the project plan, list ethics review under Article 19 and approval under Article 34(2) as separate items, each with its own duration, instead of merging the estimates into one.
4. Prepare the three legal bases for trial sample import together. For imported trial samples, prepare simultaneously the registration exemption under Article 17(4)(9), the import and export exemption under Article 26(8)(4), and the ethics review conclusion under Article 19.
5. Cover the six information items of Article 35(3) in the consent form item by item. Present the required information as a checklist inside the consent form, which helps the committee verify completeness and helps subjects understand what they are agreeing to.

5. Verification checklist

• □ Confirmed that ethics review applies to clinical trials of medical devices under Article 19(1)
• □ Obtained the currently valid ethics review committee charter and submission list under Article 19(2)
• □ Verified that no committee member falls within the dependency situations of Article 19(3)
• □ Scheduled ethics review and the approval of Article 34(2) as two independent stages
• □ Prepared the registration exemption, import and export exemption and ethics review bases for the trial samples
• □ Confirmed that the informed consent form covers all six information items of Article 35(3)
• □ Confirmed that the trial subjects fall outside the prohibited categories of Article 35(6)

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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