Uzbekistan will implement a new regulatory system in the pharmaceutical sector for a simplified procedure for registering medicines and medical devices, the Director of the Pharmaceutical Product Safety Center Alisher Temirov told Uzbekistan 24 in an interview.
According to him, a draft resolution of the Cabinet of Ministers creating a new regulatory system in the pharmaceutical sector was discussed at a government meeting chaired by the president on Monday.
He said that for the first time the provisions of the draft were fully compliant with international standards.
"In practice, the system that we have now for registering medicines is not fully aligned with international standards. This undermined exports of our local manufacturers. Now, with the involvement of international experts, an updated system will be implemented," he noted.
One of the key novelties will be a fast-track registration of generic drugs.
"Once the resolution is adopted no more additional clinical trials will be required for the registration of generic drugs. In addition, a mechanism for registration based on technology transfer and state registration of biomedical cell products is being introduced – provisions that were previously absent in regulatory documents," said the head of the center.
Temirov added that, as stated in the August presidential decree, the system for registering medical devices would now be differentiated into four safety levels, united under the single definition - medical equipment.
"For the first category – the safest – the application review period has been reduced from 155 to 60 days. For the second category, it will be 90 days, and for products of the third and fourth categories – up to 120 days," he explained.
According to Temirov, the new system is aimed not only at improving the quality of regulation, but also at supporting domestic manufacturers.
"Our companies will be able to go through fast-track registration procedure abroad." While, the fast-track registration of new medicines that have already undergone state registration in countries such as European states, the USA, Japan, and Korea will become possible in Uzbekistan,” added Alisher Temirov.
He said that procedures for extending the validity of registration certificates had been simplified and priority areas for registration have been established. This primarily concerns orphan drugs, original medicines not previously registered in Uzbekistan, as well as essential medicines that are in short supply on the domestic market.
Abdulla Azizov, Director of the Agency for the Development of the Pharmaceutical Industry, previously stated that the president had given directives to revise reference prices for medicines, as a result of which the average cost of more than 2,600 drugs could drop by 40-60%. According to him, about 65% of imported medicines are not available in neighboring countries, and prices of a number of items have been inflated.
