GxP-summit – venue for regulators meetings
The III GxP-summit takes place in Yaroslavl, where not only the young and potential pharmacists meetings with the key stakeholdersof national pharmaceutical industry are being 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 qulified 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 Hangurian manufactures, as a result of which 11 GMP certificates were issued and only 3 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 2016-2018 period, thus the total sales of Hungarian medicines was USD 569,39m or 128,47m of packages at the 2018 year end. The Hugarian mediciens 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 rigestered in Russia. At the same time 35 drugs are localized at the Fininshed Dosage Form stage, 24 drugs are localized at the packaging stage, 119 drugs are not localized.
The main market for medicines realese from Hungaury to Russia is retial commercial market. The largest volume of medicines sales was recorded in “G03-Reproductive hormones and reproductive system modulaters” 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 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 Hunguary 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 Hunguary in Q1 2019 for USD 129,72m and 22,93ea in volume terms: “Lordestin” (INN – Desloratadine) and “Bidop” (INN – Bisoprolol).
- What is in the Programme of V GMP-conference?
- The rules of organizing and conducting inspections of drug manufacturers for the compliance with GMP requirements have been changed
- FSI “SID & GP” of the Ministry of Industry and Trade of the Russian Federation and company Sandoz held the first online forum on biotechnologies
- The SID&GP under the auspices of the Ministry of Industry and Trade of the Russian Federation conducted the first online inspection of Roche’s manufacturing site
- Rules for organizing and conducting inspection of pharmaceutical manufacturers for compliance with GMP requirements have been changed