GxP-Summit – Venue for Regulators Meetings

The III GxP-summit took place in Yaroslavl, where not only the young and potential pharmacists meetings with the key stakeholders of the national pharmaceutical industry were held, but also the GMP-regulators reception on the highest level. Summit’s special guest was Dr. Mátyás Szentiványi – Director of National Institute of Pharmacy and Nutrition (OGYÉI) in Hungary.

On the 3rd of July, 2019 the Deputy Head of the Russian State GMP Inspectorate, Vladislav Shestakov met with the Director of National Institute of Pharmacy and Nutrition (OGYÉI) in Hungary, Dr. Mátyás Szentiványi. During the meeting, they have discussed the GxP-summit high practical relevance of solving problems with the qualified personnel and the perspectives of Hungarian students participation at such event the next year. The issue of GMP-inspections was not neglected by the regulatory agencies’ representatives of the two countries. In particular, the State Institute of Drugs and Good Practices (SID&GP) has conducted 17 inspections of Hungarian manufactures, as a result of which 11GMP certificates were issued and only manufacturing sites received negative decisions. As well as that the representatives of Russia and Hungary have discussed the cooperation opportunities in the field of educational programs and joint inspections.

It is to remind that according to the independent industry-specific analytical agencies, 165  tradenames’ sales were recorded in the 2016-2018 period, thus the total sales of Hungarian medicines were USD 569,39m or 128,47m of packages at the 2018 year end. The Hungarian medicines total sales amount on the Russian market was USD 136,33m or 31,48m of packages in volume terms as of Q1 2019.

According to the State Register of Medicines – 178 drugs from Hungary were registered in Russia. At the same time, 35 drugs are localized at the Finished Dosage Form stage, 24 drugs are localized at the packaging stage, 119 drugs are not localized.

The main market for medicines release from Hungary to Russia is a retial commercial market. The largest volume of medicines sales were recorded in “G03-Reproductive hormones and reproductive system modulators”  group as of Q1 2019. In the second place in terms of sales volume are the medicines of “M03- Muscle relaxants” group, in the third place are the medicines of “C09-Drugs affecting on the renin-angiotensin system” group. According to the drugs’ sales in Q1 2019, the first place holds “Mydocalm” (International Non-proprietary Name (INN) – Tolperisone), centrally acting muscle relaxant for symptomatic therapy of muscle spasm or other diseases, followed by hypersthenia or dystonia. It was sold out for USD 12,59m or 1,83m of packages in volume terms. The “Mydocalm” (INN – Tolperisone) injections’ manufacturer is “Gedeon Richter” PLC, Hungary. In the second and third places are the well-known drugs for every consumer such as “No-Spa” (INN- Drotaverine), which has relaxing,  musculotropic, vasoconstrictive and hypotensive effects and also “Suprastin” (INN – Chloropyramine) as an antihistaminic drug. As of Q1 2019, medicines from the Vital and Essential Drugs list were sold out by 42,8% in value terms (USD 58,4m).

In terms of Russian export to Hungary according to the forms of statistical reporting 2lek-prom, five types of drugs manufactured by “Gedeon Richter-RUS” CJSC were exported in 2018 for USD 221k in value terms and 195,67ea in volume terms: “Mydocalm” pills (INN – Tolperisone), “Lordestin” (INN – Desloratadine), “Pregabalin” (INN – Pregabalin), “Bidop” (INN – Bisoprolol), “Klion” pills (INN – Metronidazole). Two types of drugs manufactured by “Gedeon Richter-RUS” CJSC were exported from Russia to Hungary in Q1 2019 for USD 129,72m and 22,93ea in volume terms: “Lordestin” (INN – Desloratadine) and “Bidop” (INN – Bisoprolol).