Uzbekistan is strengthening its pharmaceutical regulation framework by introducing new requirements for assessing the effectiveness of medicines based on international scientific evidence.

The reform represents a shift toward evidence-based medicine and greater transparency in the drug registration process.

Introduction of evidence-based evaluation

 

Under the new framework, the effectiveness of medicines will be assessed using international scientific sources and methodologies.

In particular, the evaluation will rely on:

• meta-analyses;
• randomized controlled trials;
• systematic reviews.

These assessments are conducted during the state registration process to ensure that medicines meet internationally recognized standards of efficacy.

Use of international scientific databases

 

A key innovation is the formal reliance on leading global medical databases and sources, including:

• Cochrane Library;
• PubMed;
• WHO guidelines and essential medicines lists;
• NICE and other international clinical guideline platforms.

In total, 12 recognized international sources are used to verify the effectiveness of medicines, aligning Uzbekistan with global best practices.

Classification of medicines based on effectiveness

 

Following evaluation, medicines will be categorized into three groups:

• effectiveness confirmed (supported by international evidence);
• effectiveness not confirmed;
• effectiveness not studied.

This classification introduces a clearer regulatory distinction between medicines and enhances transparency for both regulators and market participants.

Role of independent expert commissions

 

The assessment process will be carried out by independent scientific commissions composed of qualified experts in medicine and pharmaceuticals.

These commissions:

• operate on principles of independence and objectivity;
• analyze international data sources;
• issue formal conclusions on the effectiveness of medicines.

Their findings form the basis for regulatory decisions on registration and continued market access.

Transparency and public disclosure

 

The results of effectiveness assessments will be:

• submitted electronically to the competent authority;
• published on an official website.

This introduces a new level of transparency in the pharmaceutical market and allows stakeholders to access information on the scientific validity of medicines.

Scope and exclusions

 

The framework does not apply to certain categories of medicines, including:

• locally developed original medicines submitted for registration;
• homeopathic products;
• certain generic medicines for external use.

This indicates a targeted approach focused primarily on medicines where international evidence can be reliably assessed.

Part of broader pharmaceutical reform

 

The new framework forms part of a wider reform aimed at:

• aligning drug regulation with international standards;
• ensuring availability of safe, effective and high-quality medicines;
• improving trust in the pharmaceutical system;
• supporting integration into global regulatory and trade systems.

Implications

 

The reform introduces several important implications:

• pharmaceutical companies will face stricter evidence requirements for registration;
• market access will increasingly depend on internationally recognized clinical data;
• regulatory transparency will improve through public disclosure mechanisms;
• the healthcare system may see a gradual shift toward clinically validated treatments.

Uzbekistan is moving toward a more rigorous and transparent pharmaceutical regulation model based on international scientific evidence.

This approach is expected to enhance the quality of medicines in the market while aligning the country with global regulatory standards.

The new rules will enter into force on 5 July 2026.