Tashkent, Uzbekistan (UzDaily.com) -- At the beginning of the year, legislative changes regarding the pharmaceutical market were adopted in the Republic of Uzbekistan. The country will begin to implement a new system of pharmacological surveillance, introduce a ban on storing drugs in warehouses without the necessary certificates, and will also work on mutual recognition of GMP certificates with Russia. These changes can improve the safety situation of drugs sold in the republic, Olzhas Satybaldin, a representative of the international biopharmaceutical company AstraZeneca, told UzDaily.

At the end of January, the President of the Republic of Uzbekistan signed a decree “On additional measures to regulate the pharmaceutical industry,” according to which a pharmacological surveillance system is being created in the country. It will begin operating in July and will be aimed at promptly identifying and timely responding to potential threats associated with the use of drugs.

“Pharmacovigilance is a comprehensive system for monitoring the safety of medicines, which also obliges doctors to report adverse events in patients after using medicines as soon as possible so that they have the opportunity to react promptly. For example, as a general rule, several serious indicators must be reported to regulators within 24 hours, including threats to life, disability, and other events requiring medical intervention. Consolidating pharmacovigilance requirements will allow us to systematize information, analyze the effectiveness and safety of drugs, as well as how correctly they are used by doctors and patients, and react in time to prevent tragedies, which, unfortunately, sometimes occur,” emphasized Olzhas Satybaldin.

According to him, the pharmacovigilance system was working in the country before the signing of the decree, but it did not fully comply with the standards of international practice. Now the standard of good pharmacovigilance practice - GVP - is being introduced in the republic, and the Ministry of Health is creating an electronic system for collecting and analyzing information about adverse reactions to drugs.

In addition to pharmacovigilance, the decree implies the introduction of another standard – good storage practices (GSP). According to it, a quality control system for storing medicines will be introduced in Uzbekistan, that is, it will actually be prohibited to store medicines in customs and other warehouses that have not received a certificate of compliance with the standard. True, the ban is introduced only from 1 January 2026, probably to give warehouses time to bring the infrastructure into proper condition.

“This is a very important change in legislation, which will improve the quality of storage of drugs and thereby increase the investment attractiveness of the country. When entering the Uzbekistan market, international manufacturers were faced with the fact that warehouses for storing medicines did not meet the necessary requirements. For example, you cannot simply store all medications together on shelves; there are groups of medications that must be stored separately and not mixed. In addition, Uzbekistan is a country with a special temperature regime, particularly in summer. Therefore, the requirements for the cold chain must be high. But international companies had questions regarding compliance with the rules of distribution practice, including the storage of drugs in the country. We talked a lot about this, and the regulator heard us,” said an AstraZeneca representative.

Also at the beginning of the year, it became known that Uzbekistan and Russia were ready for mutual recognition of GMP certificates for medicines. We are talking about certificates of good manufacturing practice - a unified system of requirements for the organization of production and quality control of medicines from the beginning of processing of raw materials to the receipt of finished products. According to Olzhas Satybaldin, this will help bring factories in Uzbekistan to the level of Russian production, which will affect the quality of products. Also, mutual recognition of GMP certificates will simplify the entry of drugs from Russia and other countries that have a Russian certificate into the Uzbek market.

“Positive changes are taking place in the legislation of Uzbekistan, which provide a reasonable understanding that the lives of citizens will improve in the context of the provision of medical care and drug safety. Of course, there are still problems that require attention. Thus, drugs continue to enter the country through “gray” channels: drugs are imported in suitcases and sold without receipts. They, of course, cost less, but this does not make them safer; on the contrary: drugs are imported without observing the cold chain, are stored incorrectly, and falsified drugs are also found in the packaging of the real drug. As a result, patients may be poisoned after taking medications or there will be no therapeutic effect. We are confident that the situation with drug quality control in Uzbekistan will still be adjusted, and the rules for the market will become stricter in terms of compliance with requirements,” added Olzhas Satybaldin.