Russian and British regulators signed a Memorandum on Cooperation in carrying-out drug manufacture inspections
During the business meeting in London between the State Institute of Drugs and Good Practices of the Ministry of Industry and Trade of the Russian Federation and the Medicines and Healthcare Products Regulatory Agency of the United Kingdom of Great Britain and Northern Ireland (MHRA), a Memorandum on Cooperation in carrying-out GMP inspections of drug manufacturers was signed.
On 29 January, 2019, representatives of FSI “SID & GP” supported by the Trade Delegation of Russia in the UK met with representatives of the Medicines and Healthcare Products Regulatory Agency of the United Kingdom of Great Britain and Northern Ireland. The key topic of the meeting was cooperation between regulatory authorities of the two countries.
Based on the data for 11 months of 2018, sales of drugs from the UK comprised 67.48 billion rubles in monetary terms and 131.13 million packs in volume terms. Currently, the UK is fifth in the list of countries selling drugs on the Russian market in monetary terms after Russia, Germany, the USA and France. The share of British drugs in the total volume of sales for 11 months of 2018 was 6% in monetary terms and 3% in volume terms. The dynamics of sales of British drugs on the Russian market for 11 months of 2018 demonstrated a growth by 8.31% in monetary terms and by 0.8% in volume terms as compared with the same period of 2017.
The main goal of signing the Memorandum is to establish a mechanism of cooperation using which the countries, governed by their legislation, strive for sharing the experience and competences with inspectorates, implement common educational initiatives, carry out joint training inspections, participate in expert events organized by the parties.
“We hope that such an agreement, having the legal basis, will help the inspectorates of the two countries cooperate regularly both in sharing the information as requested and in elaboration of bilateral approaches to carrying-out inspections, common requirements for classification of non-conformities found by our inspectors, which, in its turn, will create the environment for professional reliance and recognition. Globally, our cooperation will promote reduction of regulatory barriers for the business and enhancement of mutually-beneficial trade relations between the countries”, emphasized in his speech the Director of the State Institute of Drugs and Good Practices of Minpromtorg of Russia Mr. Vladislav Shestakov.
Within the business meeting, colleagues shared the information about the structure of the inspectorate and the regulatory system of their countries. The parties discussed the issues of organizing joint workshops and training inspections. A part of the meeting was dedicated to discussion of technical issues of GMP inspections: Russian experts talked about the structure and the specialization of the Russian GMP inspectorate, the procedure for organizing inspections, most frequent deficiencies; British colleagues presented their approach and the policy in terms of
GMP/GDP inspections, the procedure for selecting the sites, the order of certification and licensing of drug manufacturers.
Besides, Russian experts held a business meeting with the Trade Delegation of Russia in the UK. The issues and suggestions on cooperation in promoting export from Russia were discussed.
At the end of the meeting the management of MHRA were given the invitations to participate in the IV All-Russia GMP Conference with international participation which will be held in Kaliningrad on 23-25 September, 2019 and the offer to be observers during inspections of British sites by the Russian inspectorate – it is planned to have 5 of such in 2019. Representatives of FSI “SID & GP” expressed their will and readiness to take part in the next GMDP conference to be held by MHRA in November 2019.
“This Memorandum proves that, in spite of the current political crisis, experts continue collaboration for the benefit of patients’ health impacting in a positive way the dynamics of development of trade relations between the two countries and establishing a positive image through professional recognition”, commented signing of the document the Director of the State Institute of Drugs and Good Practices of Minpromtorg of Russia Mr. Vladislav Shestakov.
- 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
- Pharma is under control