|The department of technology of endocrine drugs of the All-Soviet-Union Scientific Research Institute of Automation (VNIIA) and Moscow Drug Products Plant No. 1 served as the basis for creating the All-Soviet-Union Research and Development Institute of Blood Substitutes and Hormonal Drugs Technologies (VNIITKGP).|
|In accordance with the order of the Ministry of Medical Industry dated March 18, 1974 № 107, the Scientific Council of VNIITKGP was established in order to consider the main issues of scientific activity, which is operating until nowadays.|
|Due to the merger of the Ministry of Medical Industry and the Chief Directorate of Microbiological Industry under the USSR Council of Ministers, VNIITKGP was transferred to the Ministry of Medical and Microbiological Industry. The Institute was the leading research institution in the field of creation, study, development of technology and industrial production of blood substitutes, blood preservatives, hormonal and organotherapeutic medicines, their synthetic substitutes, suture surgical materials from animal raw materials, biologically active substances, as well as the base organization of the Ministry of Medical and microbiological industry standing for standardizing the above-mentioned groups of medicines.|
|The VNIITKGP was renamed to become FSI «State Institute of Blood Substitutes and Medical Preparations» (FSI «SIBS & MP»). During the 1990s, which were the difficult time for the whole country, the Institute was the only one of the 7 specialized scientific institutions in the industry to preserve its structure and drugs development functions.|
|The Federal State Institution «State Institute of Blood Substitutes and Medical Preparations» was transferred to the Ministry of Industry, Science and Technologies of the Russian Federation.|
|The main activity of the Institute was the implementation of applied scientific research in the field of medicine and pharmacology in the area of studying mechanisms of medicines’ action on the human body, studying and development of medicines and medical devices. Over the past 10 years, the Institute has created 38 drugs (blood substitutes, organotherapeutic drugs, genetically engineered insulins, and others), the majority of which have been introduced into production at the country’s largest pharmaceutical enterprises.|
|FSI «State Institute of Blood Substitutes and Medical Preparations» was transferred to the Ministry of Industry and Trade of the Russian Federation.|
|The Institute was renamed to become the Federal State Institution «State Institute of Drugs and Good Practices» (FSI «SID & GP»). FSI «SID & GP» was accredited as the expert organization engaged in the license control of pharmaceutical enterprises located in the Russian Federation, in the composition of the commission of the Minpromtorg of Russia.|
|FSI «SID & GP» was authorized to inspect the manufacturers of human drugs effecting the manufacturing outside the Russian Federation to check the manufacturers’ compliance with the GMP Rules with the purpose of issuing the certificates of the drugs manufacturers’ compliance with Good Manufacturing Practice.|
|Beginning of the inspection of the manufacturers of human drugs effecting the manufacturing outside the Russian Federation and supplying their products to the pharmaceutical market of Russia for compliance with Good Manufacturing Practice. The GMP I all-Russian conference with the participation of foreign specialists was carried out, bringing together the pharmaceutical industry experts and the representatives of the regulatory bodies and specialized associations.|
|The Russian Ministry of Industry and Trade and the State Institute of Drugs and Good Practices (SID&GP) have jointly initiated the pre-application procedure for the Russian Inspectorate to join the Pharmaceutical Inspection Co-operation Scheme (PIC/S). Its membership will allow peer-to-peer cooperation with inspectors from all over the world, sharing experience and fair discussion of inspections related issues with foreign colleagues. The Russian Ministry of Industry and Trade along with the SID&GP provided significant support for the opening of the independent ISPE branch in Eurasia. The goal here is to gain access to global trends and international expertise in pharmaceutical engineering for the pharmaceutical community of the Eurasian Economic Union. Publication of the monograph «What Is Good And What Is Bad In Pharmaceutical Production» by Vladislav Shestakov and Yuriy Podpruzhnikov. Director of the Institute was awarded the «Honorary Chemist» title and state awards of the Syrian Arab Republic, in recognition of SID&GP staff’s contribution to inspection of Syrian pharmaceutical plants. Winning the All-Russia open contest of pharmaceutical experts ‘Platinum Ounce’ in the nomination «For contribution to implementation of GMP-standards in Russia».|
|The quality management system of FSI «SID & GP» is certified on compliance with the requirements of the international standard ISO 9001: 2015 and the national standard GOST R ISO 9001-2015. The Institute’ Director, Vladislav Shestakov, in the opinion of more than 500 pharmaceutical industry experts, was recognized as the most influential person in the development of GMP in Russian and international pharmaceutical sphere and won the “Influence Rating” award. FSI «SID & GP» held the III All-Russia GMP-Conference with international participation in Kazan. The Conference set a record for the number of guests and participants – more than 2,000 specialists from Russia and other countries. FSI «SID & GP» celebrated the anniversary date – the 45th anniversary of its founding.|
|The FSI “SID & GP” signed cooperation agreements with a number of countries on good manufacturing practice (The UK’s MHRA, Spain’s AEMPS, the Republic of Cuba’s CECMED, Chile’s ISP, and the Agency for the Development of the Pharmaceutical Industry under the Ministry of Health of the Republic of Uzbekistan).|
On November 12, 2019, the Russian Federation received a positive assessment of the pre-accession application submitted to the Pharmaceutical Inspection Cooperation Scheme (PIC/S).
Experts of the FSI “SID & GP” took part in the training of representatives of the Ministry of Health of the Republic of Nicaragua.
The terms of reference of the Working Group on Pharmaceutical Inspections for Compliance with the Rules of Good Practices for the circulation of medicines within the framework of the EAEU.
A cooperation agreement was signed with the Pirogov Russian National Research Medical University on joint implementation of projects in the field of development of medicines for children.
|More than 340 remote inspections of foreign pharmaceutical manufacturers were carried out.|
A subsidiary organization was established – National Center of Reference Standards”.
During the period of border closures in response to the COVID-19 pandemic, the FSI “SID & GP” of the Ministry of Industry and Trade of Russia conducted an inspection in a remote format for the first time (the production site of the Roche plant, Basel, Switzerland).
The V All-Russian GMP Conference with international participation was held for the first time in a virtual format.
FSI “SID & GP” has received an extension of the scope of accreditation with the ability to provide pre-licensing consulting services for pharmaceutical distributors.
On December 22, 2020, a joint membership application was submitted to the PIC/S.
The recertification audit of the quality management system for compliance with the requirements of ISO 9001:2015 (national equivalent is GOST R ISO 9001-2015)was completed.
The first GLP PLANET scientific conference was held in St. Petersburg with the support of the FSI “SID & GP”.
|Cooperation agreements were signed with the national regulatory authorities of Algeria, Venezuela, and Montenegro.|
On April 22, 2021, the grand opening of the Eurasian Academy of Good Practices took place.
The first GxP-Fest-2021 International Student Festival was organized by the Eurasian Academy of Good Practices with the support of the FSI “SID and GP”.
A virtual simulation pharmaceutical complex “VR Facility 2.0 Solid Dosage Forms” was presented at the VI All-Russian GMP Conference with international participation in St. Petersburg.
|FSI “SID & GP” of the Russian Ministry of Industry and Trade became the thought leader of the new concept and the new name of the Academician Semashko Russian Pharmaceutical Forum.|
Russia’s application to join the Pharmaceutical Inspection Cooperation Scheme (PICS) was frozen.
As part of the VII GMP conference in Irkutsk, a master class on good manufacturing practice and GMP inspection in the format of an interactive quest was held.
At the Global Regulators Conclave held in India in September, Vladislav Shestakov came up with an idea of forming a new Global Association of Pharmaceutical Inspectorates (GAPI) to promote regulatory cooperation and industry partnership. The initiative was actively supported by the conclave participants.
The simulation virtual pharmaceutical complex “Virtual Facility 2.0. Solid Dosage Forms” was presented in Nicaragua at a congress on pharmaceuticals and immunobiology.