Customer Requirement: A global Non-profit organization in the area of female health & wellness wanted to obtain drug device registration and market authorization for their contraceptive that included its administration device, in CIS region, including Azerbaijan, Kyrgyzstan and Tajikistan. The contraceptive was classified as a drug-device combination product for which regulations are challenging to navigate through particularly for CIS countries. The company had no previous experience in this region and was looking to partner with CIS region experts in the field to support their requirement.
Problem Statement: Registering drug-device combination products in CIS countries is associated with many challenges. One of the main issues is the lack of harmonization and uniformity in the regulatory requirements for member countries (Azerbaijan, Kyrgyzstan, and Tajikistan). Each CIS country has its own registration process, documentation, and evaluation/assessment criteria for a given product; different levels of expertise and resources of each national competent agency can complicate registration processes more and cause inconsistency and delays in decision-making and review processes. It is also difficult to stay updated with and gain access to changes in regulations. Additionally, language barriers and differences in the interpretation of technical data can hinder effective communication between authorities and manufacturers. Navigating these regulatory complexities demands a comprehensive understanding of each country’s specific requirements and a local network.
Key Objectives: To stay ahead of the evolving regulatory landscape for successful drug-device registration and market authorization Azerbaijan, Kyrgyzstan, and Tajikistan.
DDReg Solutions and Processes Adopted: The dedicated regulatory team at DDReg navigated through the dynamic and complex requirements for drug-device products of the CIS countries. It classified the drug-device products based on its potential application risk to determine its requirements. Through its extensive local network and partners in the associated countries, the regulatory team at DDReg could obtain first-hand access to the most recent regulations. The local partners would liaise with relative agencies to get regulatory updates and communicate them to DDReg. The team thoroughly worked to compile the dossier for the drug-device combination product, keeping in mind the updated and recent regulatory requirements.
Business Impact: DDReg successfully brought the drug-device combination contraceptive to target CIS countries of the female health product organization. In doing so, the business relationship between both parties strengthens as did DDReg’s capabilities in bringing combination products to the CIS market.
Want to know more about drug-device combination products? Read our blog on Drug-Device Products: Navigating Through the EU.