Regulatory Services in Kazakhstan

Kazakhstan is a member of the Eurasian Economic Union (EAEU) in addition to Armenia, Belarus, Kyrgyzstan, and Russia, which influences state policies. As different guidelines for the same region became a challenging task for manufacturers and exporters, the EAEU implemented unified procedures for common drug registration procedures. The National Center for Drug Expertise, medical devices and Medical Equipment oversees the evaluation and regulation of medicinal products. This agency falls under Kazakhstan’s Ministry of Health. Marketing authorization holders (MAHs) are not required to be residents of Kazakhstan; however, an applicant must be. Dossiers are accepted in electronic and paper-based formats in Russian or Kazakh and must include the product’s composition, production specifications, and shelf life, as well as quality control techniques. Overall, the requirements set forth for product registration and approval are among the most stringent in the region. This makes it difficult for foreign manufacturers to obtain market authorization for their products and even more so in the local language. Important data can be miscommunicated which can lead to market authorizations being rejected or, in the case of product renewal, products being recalled.

As a leading global contender, DDReg’s regulatory services in Kazakhstan provides on-going support and development of the customized strategies during all regulatory phases while keeping track of the most recent regulatory requirements to ensure high quality and timely submissions. We deliver reliable safety measures, ensure risk mitigation, and collaborate with experts to facilitate effortless delivery of product launches, regulatory filings, and market authorizations.