общая и частная фармакопейная статья (in context)
English translation: general and individual/specific pharmacopoeia(l) monographs
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| 08:53 Oct 9, 2020 |
| Russian to English translations [PRO] Medical - Medical: Pharmaceuticals / pharmacopoeia | |||||||
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|  Selected response from: Oleg Lozinskiy Russian Federation Local time: 05:45 | ||||||
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| 4 +2 | general and specific/individual pharmacopoeia/pharmacopoeial monographs |
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Answers
1 hr confidence: 
peer agreement (net): +2
peer agreement (net): +2general and specific/individual pharmacopoeia/pharmacopoeial monographs Explanation: The first part of Volume I of the Union's Pharmacopoeia includes 157 harmonized general pharmacopoeial monographs containing general information on applying the pharmacopoeial analysis and its methodologies, methods of biological and microbiological tests, reagents, devices and apparatus for analyzing the quality of both medicines already available in the market and new medicines still under development. It is planned to fill the document with new general and specific monographs as its next volumes will be prepared for publication. http://www.eurasiancommission.org/en/nae/news/Pages/12-08-20... The second stage envisages the development of harmonised specific pharmacopoeial monographs for pharmaceutical substances (including substances for veterinary pharmaceuticals), natural medical raw materials(plant, animal), pharmaceuticals and other medicines by the authorised bodies of the Member States in circulation of medicines on the basis of the Pharmacopoeial Committee of the Union. Subsequent volumes of the Pharmacopoeia of the Union include harmonised individual pharmacopoeial monographs for pharmaceutical substances (including veterinary pharmaceutical substances), natural medical raw materials (plants, animals), pharmaceuticals and other medicines. Harmonised general and individual pharmacopoeial monographs, which are not included in the regular edition of the Pharmacopoeia of the Union, may be issued in the form of addenda. The edition contains 304 new general and individual pharmacopeial monographs for pharmaceutical substances, natural medical raw materials, medicines, radio-pharmaceutical medications and raw materials for radio-pharmaceutical medications, homeopathic medicines, and medical products. https://www.google.ru/url?sa=t&rct=j&q=&esrc=s&source=web&cd... P.S. По поводу "individual" vs. "specific" - они в одном и том же документе 2015 года ухитрились использовать и то, и другое. Но в информации о принятии документа 2020 года используют "individual". -------------------------------------------------- Note added at 1 час (2020-10-09 10:31:40 GMT) -------------------------------------------------- Sorry, в информации о принятии документа 2020 года используют "specific". -------------------------------------------------- Note added at 1 час (2020-10-09 10:44:41 GMT) -------------------------------------------------- В практике СССР и России использовалось и используется "individual": Blood products were first represented in the State Pharmacopoeia of the USSR IX and X editions (1961 and 1968) by a single monograph "Gamma globulin for the prevention of measles". During the next 50 years there were no general monographs (GM) or individual monographs (IM) in the State Pharmacopoeia of the Russian Federation that laid down regulatory requirements for the quality of human blood products. In this regard, there came a need to develop GMs and IMs on human blood products taking into account modern approaches, specific features of a complex multi-level production technology and modern harmonized requirements for blood products, ensuring their quality, efficacy and safety in humans. The Order of the Ministry of Health of the Russian Federation "On the adoption of general monographs and individual monographs” No. 768 of 21.11.2014 brought into effect 32 GMs and IMs on blood products, including 11 GMs and 5 IMs that have been introduced into the national pharmacopoeial texts for the first time. The monographs were developed with due regard to modern pharmacopoeial methods of analysis that account for a high level of quality control of this type of products. https://www.vedomostincesmp.ru/jour/article/view/53 |
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