In Moscow, an agreement was signed between the State Institute of Drugs and Good Practices (SID & GP) and the Spanish Agency of Medicines and Medical Devices (AEMPS). Under the agreement, the two organizations will cooperate in part of inspections of pharmaceutical facilities for compliance with GMP guidelines and in taking measures against substandard, counterfeit medicines.
SID & GP continues to expand the geography of cooperation with foreign GMP inspectorates. Thus, 5th March, an agreement on cooperation was signed with the Spanish AEMPS. The parties emphasize that, in the context of rapidly developing manufacture of medicines and active pharmaceutical ingredients outside the country of manufacture, regulators from all over the world are sorely in need of establishment of reliance aimed at timely sharing of the information, experience and developing unified approaches to inspections at manufacturing sites. Ultimately, the main goal of every regulator is to provide patients with high-quality drugs and prevent penetration of counterfeit products to the market.
Signing of the agreement with Spanish colleagues is the result of out interaction aimed at continuous training of our inspectors and sharing of the information about the structure and activities by GMP inspectorates, peculiarities of inspections and national regulations in terms of GMP, GDP, effective certification and licensing procedures,
said the Director of SID & GP Mr. Vladislav Shestakov.
As a reminder, starting from 2016, 64 GMP inspections of Spanish drug manufactures have been carried out as of the current date. 39 GMP certificates issued. Today, there are 4 more inspections yet to be carried out according to the schedule. Four sites are waiting for the resolution on issuance of the Russian GMP-certificate, and two companies have initiated a withdrawal of their applications for an inspection.
Formalizing our cooperation with AEMPS (from a legal prespective) will allow Russian and Spanish inspectors to be more actively involved in GMP inspections as observers. Indeed, our Spanish colleagues have more than once attended the inspections carried out by Russian inspectors in Spain as observers. We will share the experience of taking measures against counterfeit drugs and will continue to practice joint training of our inspectors by organizing training inspections in Spain and in Russia,
commented on signing of the agreement Mr. Vladislav Shestakov.
Regardless the negative dynamics in 2018, in volume terms, the sales of Spanish drugs in the Russian market have reached 1,329,432 packs. In the period from 2015 to 2018, Spanish drugs retained their position in the Russian market – their share was 0.3% of the total volume of the drugs market. In monetary terms, otherwise, the volume of sales in 2018 was at the level of the previous year and comprised RUB 1,898,133,704.78.
The mission of the AEMPS is to ensure quality, safe, effective and accessible medicines and medical devices to citizens likewise to provide them with accurate related information.
In the framework of a growing globalization of the manufacturing of medicines and active substances is of great interest, for the efficient development of AEMPS mission, to arrange mechanisms for the exchange of information and cooperation with authorities of other countries with similar development roles.
Hence, through this agreement, both institutions will strengthen the activities of exchange of information and experiences among the pharmaceutical inspection services to foster and harmonize criteria in order to impact in the quality of these activities.
Furthermore, falsified and illegal medicines and medical devices, spread out worldwide, imply an important risk for public health. The manufacturing, distribution and sale of these products are an awfully lucrative and illegal business which entails a global threat for patients’ health. Thus, by virtue of this agreement, the FSI “SID & GP” and the AEMPS will additionally collaborate by sharing strategies in this area what will certainly strengthen the effectiveness of these actions for both institutions to safeguard citizens’ health.