Rules of good laboratory practice: analysis of changes in the legislation
Abstract
New rules of good laboratory practice in the Russian Federation and the Eurasian Economic Union were adopted in 2016. The rules of good laboratory practice of the Eurasian Economic Union in the field of drugs is a document that will allow for a coordinated policy in the field of pre-clinical studies and to establish common principles and rules for the evaluation of medicinal products in the Member States of the Union with a view to forming a common medical devices market circulation. Creating uniform rules and approaches to the drugs market regulation based on international experience will increase the safety of drugs available on the market and their accessibility to the population of states - members of the EAEU.
About the Authors
N. Yu. Velts
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
T. M. Bukatina
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
E. Yu. Pasternak
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
T. N. Nikolaeva
Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
S. V. Romanova
Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
References
1. Federal Law of January 31, 2016 ¹ 5-FZ «On ratification of the Agreement on Common Principles and Rules for the Treatment of medicines in the framework of the Eurasian Economic Union.»
2. Order of the Ministry of Health from April 1, 2016 ¹ 199n «On approval of rules of good laboratory practice» (in Russian).
3. The decision of the Council of the Eurasian Economic Commission dated November 3, 2016 ¹ 81 «On approval of rules of good laboratory practice of the Eurasian Economic Union in the sphere of circulation of drugs»
4. Koreshkov W. Doors open. Rossiyskaya Gazeta [Electronic resource] 2016 (cited 28 Dec 2016). Avaible at: https://rg.ru/2016/12/20/sozdanie-obshchego-rynkalekarstv-stanet-odnim-iz-prioritetov-easo.html (in Russian).
5. Velts NYu, Alyautdin RN, Kazakov AS, Bukatina TM, Darmostukova MA. The rules of good laboratory practice. Safety and Risk of Pharmacotherapy 2016; 1: 28–32 (in Russian).
6. Mokhov AA, Murashev AN, Krasilshchikova MS, Khokhlova ON, Semushina SG, Rasskazova EA, Rzhevskiy DI, Popov VS, Javorsky AN. On the need to improve the legislation on laboratory animals. The Bulletin of the Scientific Center for Expert Evaluation of Medical Products 2016; 4: 62–68 (in Russian).
7. Soldatov AA, Avdeeva JI, Alpatova NA, MedunitsynNV, Mironov AN. General principles of preclinical and clinical research in safety and efficacy of biopharmaceuticals when making changes in the manufacturing process. Biopreparation (Biopharmaceuticals) 2013; 2: 22–27 (in Russian).
Review
For citations:
Velts N.Yu., Bukatina T.M., Pasternak E.Yu., Nikolaeva T.N., Romanova S.V. Rules of good laboratory practice: analysis of changes in the legislation. Safety and Risk of Pharmacotherapy. 2017;5(1):27-31. (In Russ.)
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