Russian pharmaceutical association Inpharma discussed international regulatory practices during the Second International Forum of Pharmaceutical Inspectors in the United Arab Emirates.
During a session on regulatory features for medicines across different regions held on November 25, Inpharma executive director Vadim Kukava moderated a discussion that reviewed regulatory requirements and shared manufacturer experiences in bringing drugs to foreign markets.
Speakers included Shaikha Al Mazroui, head of the National Reference Laboratory for Drug Control at the Emirates Drug Establishment, Shanti Marlina Sibuea, acting director of Indonesian Food and Drug Authority’s Directorate of Production Supervision of Narcotics, Psychotropics, and Precursors (ONPP), and Nikita Punia, Vice President of Commerce at Pharmasyntez.
The panel examined how regulatory environments are shaped in different countries, which requirements are applied to drug circulation, and which regulatory models prove most effective for international market entry.
They also addressed key barriers manufacturers face when dealing with regulators, along with tools to speed up registration, increase transparency of requirements, and align national standards with global rules.
A particular focus was given to rapidly evolving regulatory changes in the Middle East, where quality and safety control standards have accelerated in recent years alongside expanding local production capacity.
This is creating a new level of requirements for drugmakers.
Indonesia’s experience also drew interest, as the country systematically improves drug availability by modernizing legislation, attracting investment, and supporting programs for vulnerable groups.
In closing, Kukava noted that the examples of the UAE and Indonesia demonstrate that successful pharmaceutical market development requires a flexible approach, combining global standards with local priorities.
He said this principle is also key for Russia’s pharmaceutical industry as it seeks global integration while strengthening its own technological sovereignty.
Kukava emphasized that developing domestic innovation cannot be separated from the global pharmaceutical ecosystem, as isolation hinders progress and reduces competitiveness.
For Russia, he said, it is critical to combine international practices with creating conditions that help bring innovative drugs to market.
This comprehensive approach would form the basis for quality growth in the pharmaceutical sector, strengthen drug security, and increase its social focus, Kukava added.
