1.35% is the share of Italian drugs in the Russian market
In the special economic zone «Technopolis «Moscow», the VIth meeting of the working group on industry and high technology of the Russian-Italian Council for Economic, Industrial and Currency & Finance Cooperation has been launched. It is the platform for the IInd meeting of the working subgroup on cooperation in pharmacy and biomedicine. The meeting is dedicated to discussions of the priorities in cooperation between the two countries towards inspections and securing the quality of pharmaceutical products.
Today, within the premises of the technology and innovation special economic zone of the city of Moscow – «Technopolis «Moscow», the Director of the Department of Pharmaceutical and Medical Industry Development of Minpromtorg of Russia Mr. Aleksey Alekhin and the Director General for Industrial Policy, Competitiveness and Small and Medium Enterprises at the Italian Ministry of Economic Development Mr. Stefano Firpo, are establishing the top priorities in cooperation between Russia and Italy within the meeting of the working subgroup on cooperation in pharmacy and biomedicine.
As a reminder, the share of Italian products in the Russian market of medicines consistently comprises 1.35%. In monetary terms, based on the results for 2018, the volume of Italian drugs sold within the RF territory was $254 million (with the total market volume of $21.43 billion).
«Italy is a strategically important partner for Russia, and we see the necessity to develop and strengthen cooperation between our states, including that at the level of cooperation between pharmaceutical inspectorates,» has noted the Deputy Head of the Russian GMP Inspectorate, the Director of FSI «SID & GP» Mr. Vladislav Shestakov who is also taking part in the meeting of the working subgroup. «Our main goal is to provide patients both in Russia and in Italy with high-quality and effective drugs.» As it has been pointed out in the speech by the Head of Drug Inspections Department of SID & GP Ms. Ekaterina Nikiforova, from 2016, the Russian GMP inspectorate has carried out 102 inspections of Italian drug manufacturers resulting in issuance of 58 conclusions about compliance with GMP standards. At the same time, 21 manufacturing sites have been refused issuance of GMP-certificates. The majority of GMP non-conformities found by the inspectors, which were 245 in 2018, were related to
- cross-contamination of the finished non-sterile product (in part of securing process equipment cleaning),
- storage conditions for the finished products, starting materials and packaging materials at warehouses,
- non-compliance of HPLC methods used for product release testing with the requirements of the normative document
- absence of continuous particles monitoring (sterile products) throughout the critical process in A zones.
Mr. Vladislav Shestakov and Italian colleagues have emphasized close cooperation between the inspectorates: FSI «SID & GP» and the Italian Medicines Agency (AIFA) as the national authority responsible for GMP inspections in Italy. AIFA’s inspectors participate in GMP inspections carried out by SID & GP as observers, and the Italian delegation has shared their impression of these at the meeting of the working group focusing on the professionalism of Russian colleagues and their openness for collaboration. Training GMP inspections are carried out at Italian manufacturing sites. The Italian regulator, having been notified about critical non-conformities found by the Russian inspectorate at local manufacturing sites, is very careful with such observations. «Currently, we are negotiating with the colleagues establishment of the official professional trust-based bilateral cooperation, which, I am convinced, will very soon be finalized by signing a Memorandum of Understanding,» said Mr. Vladislav Shestakov.
- 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
- Pharma is under control
- PIC/S Meetings in Toyama (Japan)
- Russia will be able to join PIC/S and break into new pharmaceutical markets