Russian and international regulations
In the Russian Federation creation, conducting preclinical and clinical trials of the drug and also its production are regulated by a few main normative documents.
- Federal law of the Russian Federation on circulation of drugs (Art. 4, 11) of April 12, 2010, No. 61-FZ; http://base.garant.ru/12174909/
- Federal Law N 241-FZ On Amendments to the Federal Law “On Circulation of Medicines“ and the Federal Law “On Amendments to the Federal Law” On Circulation of Medicines ” http://www.roszdravnadzor.ru/drugs/controllslp
As well as documents of the Eurasian Economic Commission:
Order number 170 of 12.22.15 “On the draft decision of the Council of the Eurasian Economic Commission” On the rules of registration and examination of drugs for medical use “
Order number 174 dated 12.22.15 “On the draft decision of the Council of the Eurasian Economic Commission” On approval of rules of good laboratory practice of the Eurasian Economic Union “
The Federal Law of 12.04.2010 № 61-FZ “On Circulation of Medicines”, as well as legal acts designed to implement the Act does not provide for the accreditation of organizations and institutions engaged in conducting preclinical studies of drugs, and are not assigned to any -or executive body functions of maintaining a list of such entities.http://www.roszdravnadzor.ru/drugs/controllslp/faq/88
- Order of the Ministry of Health and Social Development of the Russian Federation dated April 01, 2016 № 199n “On approval of the rules of good laboratory practice“; http://www.roszdravnadzor.ru/drugs/controllslp
- National Standard of the Russian Federation GOST R 33044-2014 “Principles of Good Laboratory Practice” (Order of the Federal Agency for Technical Regulation and Metrology of the November 20, 2014 № 1700 Article interstate standard GOST 33044-2014 enacted as a national standard of the Russian Federation 1 August 2015 This standard is identical to the international instrument OECD Guide 1: 1998 OECD Principles of good laboratory practice). ГОСТ 33044-2014
- Manual on conducting preclinical studies of drugs. Under the editorship of Mironov A.N., Bunatyan N.D. et al., M., publishing house “Grif and K”, 2012; http://www.regmed.ru/gf.aspx?id=d948ac01-192c-4347-aba6-3231678657f1
- GOST ISO series No. 10993 “Medical products. Assessing biological effect of medical products”; http://tehnorma.ru/gosttext/gost/gostdop_923.htm
- The main document defining the keeping and breeding of animals in the vivarium (experimentally–biological clinics) is a joint venture 18.104.22.16818-14 “Sanitary requirements for facilities, equipment and maintenance of experimental biological clinic (vivarium)” www.consultant.ru/document/cons_doc_LAW_155631/
- Directive 2010/63 / EU of the European Parliament and of the Council of the European Union of 22 September 2010 on the protection of animals used for scientific purposes http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&reference=A7-2013-0324&language=EN
- Guide for the care and use of laboratory animals. National Academy press. –Washington, D.C. 1996. http://www.nap.edu/openbook.php?record_id=5140&page=8
- The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH); http://www.ich.org/
- OECD protocols on testing chemical agents in toxicological studies; http://www.oecd.org/
GLP (Good Laboratory Practice) is a quality laboratory practice. It means that planning of preclinical trials, drawing up protocols and research reports are carried out based on GLP standards. Control over conducting trials and requirements for vivarium and quality of animals is in the forefront of GLP rules. Following GLP rules allows to ensure the accuracy of research results and their reproducibility.
GLP rules define the technology of conducting preclinical trials associated with determination of the test substance safety. GLP rules include:
– requirements for organization of trials;
– requirements for staff of researchers;
– requirements for rooms where trials are carried out and animals are kept;
– requirements for quality of animals, their housing and feeding conditions;
– requirements for laboratory equipment and its calibration;
– requirements for test and control substances;
– requirements for drawing up and conducting a detailed standard experimental work technique (SOP – standard operating procedure) and order of conducting trials (protocol);
– requirements for data recording and report design;
– requirements for quality control service;
– standard experimental work techniques.
It must be said that GLP rules first developed in the USA gained recognition in other countries of the world very quickly. Today virtually all developed countries regulate creation, testing and production of drugs by their national state rules and standards based on GLP requirements.