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Thailand`s FDA and Russian inspectorate will conduct a joint inspection

 On August 15, a meeting of national GMP inspectors was held at the site of the Russian-Thai business forum organized by the Ministry of Industry and Trade of Russia. The Thai FDA and the FGI GILS and NP agreed on closer cooperation, including representatives of the Thai inspectorate announced their readiness to participate in observer status at an inspection of the local site, which will be held next week.

The Russian-Thai business forum this year has become rich in events for the pharmaceutical industry. Domestic companies not only met with the largest distributors in Thailand interested in representing Russian products on their market, but also organized a productive discussion with manufacturers and regulators, and the GMP inspectorate of the two countries held a closed working meeting. Until this moment, the cooperation of the inspectorates was practically not carried out - inspections of production sites were carried out without the presence of a national regulator, and the results of inspections were not comforting.

According to Vladislav Shestakov, deputy head of the Russian state GMP inspectorate, director of FBI GILS and NP, out of 3 inspections conducted from 2016 to 2019, two production sites were refused a GMP certificate. Among the inconsistencies that were identified at both sites, violations of the requirements of the GMP rules during the validation of the packaging process were noted (not all stages of the process are included in the validation work). The Thai regulator was given a full list of criticisms prepared on the basis of work carried out by the Russian GMP inspectorate. This list has become the subject of close study of acting Ms. Patcharivan Fungnil, Head of the Biological Preparations Division, Post-Registration Control Unit, FDA Drug Control Department.

“The insufficient level of interaction between the Russian and Thai regulators leads to the fact that pharmaceutical manufacturers often do not understand the sequence of actions during GMP inspections and the procedure in case of refusal to issue a certificate of compliance with GMP standards," Vladislav Shestakov noted.

As a result, Mr. Pramout Akarapanon, the head of the biological products department of the pre-registration control unit of the FDA Drug Control Department, expressed a desire for the participation of the Thai FDA inspectors in the next inspection, which will be carried out by the FBI “GILS and NP” in Thailand in late August.

At the meeting, regulators spoke about the features of national drug regulatory systems and the work of GMP inspectors. In particular, the Thai FDA noted that, unlike Russian colleagues, whose inspectors have 80 inspectors, the Thailand inspectorate is much smaller - it is represented by only 30 specialists. At the same time, unlike Russia, the Thai drug regulatory system is more centralized, therefore, a significant part of the bilateral meeting of the Thai FDA and the FGI "GILS and NP" was devoted to explaining the structure of drug regulation in Russia and the interaction between the Ministry of Health, the Ministry of Industry and Trade of Russia, and the Ministry of Agriculture economy of the Russian Federation, and their specialized subordinate institutions (NTsESMP, Roszdravnadzor and GILS and NP).

As a result of bilateral negotiations between the Russian and Thai inspectors of the FDA of Thailand and FBI GILS and NP, they agreed to organize training GMP inspections at production sites in Thailand and the participation of FDA inspectors in GMP inspections conducted by GILS and NP in observer status. Considering the request made by Russian pharmaceutical companies that came to the Russian-Thai business forum for public analytical information about the market, by manufacturers, pharmaceutical products, regulators plan to organize the work of their analytical centers in this direction. The international information project “GMP News” and the All-Russian GMP conference with international participation, in which the Thai FDA plans to participate, can be used as public platforms for the distribution of analytical materials.

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