Uzbekistan has introduced a comprehensive regulatory framework governing the conduct of clinical trials for medical devices. The newly approved rules establish clear criteria for when clinical trials are required, define the decision-making process for initiating such trials, and regulate the roles of regulatory authorities, experts, clinical institutions, and applicants. The framework aims to ensure patient safety, scientific validity, and regulatory transparency while facilitating access to innovative medical technologies.

Medical Devices Exempt from Clinical Trials

The regulatory framework identifies specific categories of medical devices that may undergo state registration without conducting clinical trials. These include:

• Medical devices classified as low-risk (Class I) under the safety classification system;
• In vitro diagnostic devices that have been prequalified by the World Health Organization or registered with WHO support;
• Medical devices for which clinical trials have already been conducted in Uzbekistan;
• Certain devices recognized based on prior circulation and proven safety and effectiveness, subject to the submission of supporting scientific evidence.

This differentiated approach allows regulators to focus clinical trial requirements on higher-risk devices while accelerating market access for well-established or low-risk products.

Decision-Making Authority and Regulatory Oversight

The decision on whether a medical device must undergo clinical trials is taken by an Expert Council operating under the Ministry of Health. This decision is based on a recommendation from the state body responsible for the safety of pharmaceutical and medical products.

Clinical trials are conducted depending on the safety class of the medical device and must involve no fewer than 20 clinical trial subjects, with the possibility of multi-center trials for higher-risk devices. This ensures statistically meaningful results while maintaining proportionality.

Integration with the Medical Device Registration Process

The clinical trial framework is closely integrated with the broader system for the state registration of medical devices. After a positive conclusion at the initial expert review stage, laboratory testing and specialized expert examination of the medical device are carried out simultaneously.

An independent expert engaged in the specialized examination evaluates:

• The suitability and accreditation of the clinical base where the trial will be conducted;
• The appropriateness of the clinical trial design;
• The use of modern and advanced methods for assessing safety and effectiveness.

This parallel review model reduces regulatory timelines while preserving rigorous scientific assessment.

Ethical Review and Protection of Trial Subjects

A key safeguard within the framework is the mandatory ethical review conducted by a designated ethics committee. Clinical trials may not commence without a positive ethical opinion confirming that the study is ethically justified and that the rights, dignity, and safety of trial participants are adequately protected.

Participation in clinical trials is strictly voluntary and based on informed written consent. Special rules apply when trials involve minors or persons with limited legal capacity, requiring consent from legal representatives. Trial participants retain the right to withdraw at any stage without adverse consequences for their medical care.

Conduct of Clinical Trials and Monitoring

Clinical trials must be conducted in approved medical institutions by qualified investigators in accordance with recognized good clinical practice standards. Applicants are responsible for:

• Providing the medical device and related documentation;
• Ensuring insurance coverage for potential harm to trial subjects;
• Monitoring and auditing trial quality and compliance.

Adverse events must be promptly documented and reported. Where serious risks to life or health arise, the competent authority is empowered to suspend or terminate the clinical trial.

Reporting, Final Review, and Market Authorization

Upon completion of a clinical trial, a clinical trial report is prepared and submitted for final expert review. The report is assessed for consistency with the approved trial protocol and supporting documentation.

Based on the final expert conclusion, the Expert Council decides whether the medical device may be authorized for use in medical practice or whether registration should be refused. This final decision ensures that only devices meeting established safety and performance standards reach the healthcare system.

Practical Implications for Manufacturers and Importers

For manufacturers, importers, and distributors of medical devices, the new framework provides:

• Greater clarity on regulatory expectations;
• Predictable pathways for registration depending on device risk;
• Enhanced alignment with international standards;
• Improved protection against regulatory uncertainty.

At the same time, the framework reinforces public confidence by prioritizing patient safety and evidence-based decision-making.

The introduction of a structured and risk-based system for conducting clinical trials of medical devices represents an important milestone in the development of Uzbekistan’s healthcare regulation. By combining scientific rigor, ethical oversight, and administrative efficiency, the framework supports innovation while ensuring that medical devices used in practice meet high standards of safety and effectiveness

Uzbekistan has taken a significant step toward the digitalization of legal services by introducing a formal procedure for performing notarial actions remotely through videoconferencing. The newly approved regulatory framework establishes comprehensive rules for conducting notarial acts without the physical presence of individuals or representatives of legal entities at a notary office, while maintaining legal certainty, confidentiality, and procedural safeguards.

This development reflects a broader policy objective of expanding access to justice, improving service efficiency, and integrating modern information technologies into the notarial system.

Scope and Applicability of Remote Notarial Services

The approved procedure applies to notaries and their assistants, trainees, and secretaries, as well as all participants involved in a notarial act conducted via videoconferencing. All persons involved are required to ensure strict confidentiality of information obtained in the course of the notarial process.

Remote notarial actions may be performed in relation to those acts permitted under notarial legislation, provided that identity verification, capacity assessment, and procedural integrity can be ensured through digital means.

Digital Platforms and Technical Infrastructure

Remote notarization is carried out through the state electronic portal “e-notarius.uz” in conjunction with the automated information system “Notarius.” These platforms serve as the core technological infrastructure for submitting applications, verifying identities, exchanging documents, scheduling notarial sessions, and recording completed notarial acts.

Notarial actions performed via videoconference are confirmed electronically, and all relevant data is recorded in the system, ensuring traceability and legal validity.

Application and Review Process

To initiate a remote notarial action, an applicant must register on the electronic portal and verify their identity using the available authentication mechanisms. The applicant selects a notary through the system and submits an electronic application specifying the requested notarial act and providing the required information.

The notary reviews the application within a defined timeframe and informs the applicant electronically of whether the application is complete or requires correction. Notifications may be delivered through electronic channels and, where applicable, via the applicant’s registered phone number.

If deficiencies are identified, the applicant is given an opportunity to remedy them. Failure to do so within the prescribed period results in refusal of the application in accordance with notarial legislation.

Timing and Payment Procedures

Once the application is accepted, information regarding the notarial act is entered into the system, and the applicable fees are calculated automatically. Payment invoices are generated and sent electronically to the applicant.

The timeframe for performing the notarial act is determined by the notary and may not exceed the maximum period established by the procedure. Applicants are also granted limited flexibility to request an alternative time slot, subject to agreement with the notary.

Identity Verification and Legal Capacity Assessment

A central element of the remote notarial framework is the verification of identity and legal capacity. Identification is conducted using modern information technologies, including biometric verification tools such as facial recognition, as well as checks against relevant state information resources.

During the videoconference, the notary personally communicates with the parties to assess their legal capacity, understanding of the transaction, and voluntariness of consent. Where doubts arise regarding capacity, mental condition, or external pressure, the notary may suspend or refuse the notarial action and, where required, take additional verification measures.

Requirements for the Videoconference Environment

Strict requirements apply to the conditions under which videoconferencing is conducted. During the notarial session:

• No unauthorized persons may be present at the location of the parties;
• The environment must be quiet, well-lit, and suitable for clear communication;
• The video image must be clear and uninterrupted.

The notary may request a visual confirmation of the surrounding space to ensure compliance with these requirements.

Finalization and Legal Effect of Notarial Acts

Once the draft notarial document is ready, the notary explains to the parties their rights and obligations, as well as the content and legal consequences of the notarial act. The completed act is recorded in the system, assigned a registration number, and electronically certified.

Video recordings of the notarial session are automatically created and stored in the system for the period prescribed by law. These recordings serve as evidence of the performance and certification of the notarial act.

Certified documents are subsequently delivered to the parties either in person, through courier services, or by other legally permitted means.

Legal Significance and Practical Impact

The introduction of remote notarial actions represents a major modernization of Uzbekistan’s notarial system. It reduces the need for physical presence, increases accessibility for individuals and businesses, and enhances procedural efficiency, particularly for cross-regional and time-sensitive transactions.

At the same time, the framework preserves the fundamental principles of notarial activity, including personal verification, legal certainty, confidentiality, and protection of parties’ rights.

Uzbekistan has taken an important step toward strengthening the regulatory and methodological foundations of pharmaceutical quality control by formalizing the procedure for developing general and individual pharmacopoeial articles and integrating them into the State Pharmacopoeia.

This development addresses a critical aspect of pharmaceutical regulation: ensuring that quality standards for medicines and medical products remain scientifically sound, up to date, and aligned with international best practices, even in cases where specific methods are not yet reflected in the national pharmacopoeia.

The Role of the Pharmacopoeia in Quality Assurance

The pharmacopoeia serves as a core regulatory instrument, defining mandatory quality requirements for medicinal products, substances, excipients, and methods of quality control. Within this system, pharmacopoeial articles are divided into general and individual standards, each serving a distinct regulatory purpose.

General pharmacopoeial articles establish uniform analytical methods, requirements for reagents, indicators, reference standards, and testing approaches applicable across multiple categories of medicinal products. Individual pharmacopoeial articles, by contrast, define specific quality indicators and control methods for particular medicines, raw materials, excipients, or medical products.

Both types of articles are subject to periodic review, reflecting the dynamic nature of pharmaceutical science, manufacturing technologies, and quality control methodologies.

Institutional Framework for Development

The procedure for developing pharmacopoeial articles in Uzbekistan is structured as a multi-level, expert-driven process. Responsibility is distributed among a secretariat, working groups, specialized expert commissions, editorial boards, and editorial councils, with the involvement of professionals from the Center for Pharmaceutical Product Safety under the Ministry of Health.

This layered governance model is designed to ensure scientific rigor, transparency, and consistency throughout the drafting and approval process, while also allowing for the engagement of external experts from other state bodies, academic institutions, and specialized organizations.

Planning, Transparency, and Stakeholder Input

Development of pharmacopoeial articles is carried out on the basis of an annual plan approved by the leadership of the Center. This plan takes into account proposals submitted by applicants and other interested stakeholders, as well as broader developments in science, medicine, and pharmaceutical technology.

Applicants may include holders of registration certificates for medicinal products or medical devices, while interested parties encompass pharmaceutical organizations, research institutions, and higher education establishments. This approach creates a structured channel for industry and scientific input while maintaining regulatory oversight.

Information on the initiation and completion of work on pharmacopoeial articles is made publicly available, reinforcing transparency and predictability in the standard-setting process.

Scientific and International Foundations

A defining feature of the framework is its explicit reliance on scientific evidence and international harmonization. Pharmacopoeial articles are developed on the basis of:

• results of scientific research, testing, and measurement;
• contemporary achievements in medicine, pharmacy, and related sciences;
• practical experience gained from the application of new medicinal products, medical devices, and quality control methods;
• leading global pharmacopoeias, international and regional standards, and recommendations of international organizations involved in pharmaceutical quality control.

This orientation ensures that national standards do not evolve in isolation, but rather remain compatible with globally recognized quality benchmarks.

Technical and Editorial Requirements

The framework establishes detailed requirements for the structure, language, and presentation of pharmacopoeial articles. Texts must be concise, precise, and unambiguous, avoiding outdated terminology, figurative language, or unnecessary foreign terms where equivalent expressions exist in the state language.

Articles are prohibited from containing legal norms, reinforcing their technical and scientific character rather than regulatory duplication. Uniform formatting, terminology definitions, and clear internal structure are mandated to support consistent interpretation and application in practice.

Evaluation, Approval, and Integration

Draft pharmacopoeial articles undergo a structured evaluation process involving scientific review and scoring based on predefined criteria. These criteria assess scientific validity, alignment with international standards, and compliance with established methodological requirements.

Based on the outcome of this evaluation, articles may be recommended for approval, returned for revision, or rejected. Approved articles are formally integrated into the State Pharmacopoeia and introduced into practice following a defined implementation period, allowing industry and laboratories to adapt to new requirements.

Updating and Lifecycle Management

The framework also regulates how changes and additions to existing pharmacopoeial articles are made, as well as the conditions under which outdated articles may be withdrawn. Amendments may be driven by scientific progress, technological innovation, regulatory changes, or substantiated proposals from stakeholders.

This lifecycle approach ensures that the State Pharmacopoeia remains a living instrument, capable of evolving alongside scientific and industrial developments.

Regulatory Significance

Taken as a whole, this framework strengthens the institutional credibility of pharmaceutical standard-setting in Uzbekistan. By combining scientific rigor, stakeholder engagement, international alignment, and procedural transparency, it enhances confidence in the quality control system governing medicines and medical products.

For pharmaceutical manufacturers, laboratories, regulators, and international partners, these developments signal a more predictable, harmonized, and professionally governed environment for pharmaceutical quality assurance in Uzbekistan.