What You Need to Know Before Registering a Drug in Central Asia

Understand the legal framework: one region, multiple systems

Though harmonization is progressing, registering pharmaceuticals in Central Asia still involves country-specific rules:

• Kazakhstan: Fairly structured, requiring GMP certification and 8–12 months for approval.

• Uzbekistan: More complex, with local data requirements and longer processing time (up to 14 months).

• Kyrgyzstan & Tajikistan: Loosely regulated, often requiring local facilitation and longer timelines.

Registration fees range from €3,000 to €8,000, excluding translation or consulting costs.

How to avoid delays and reduce costs

Common mistakes include incomplete documentation, incorrect formatting, or language issues. To ensure success:

• Assess each country’s regulatory framework.

• Prepare validated certificates and test results.

• Work with authorized translators.

• Design a market-entry strategy aligned with local partners.

Why European manufacturers benefit from working with ACIR

ACIR Southern Europe offers full support for European companies, handling documentation, translation, submission, and regulatory follow-up—saving time, reducing risk, and ensuring faster market access.