Zobrazeno 1 - 10
of 37
pro vyhledávání: '"registration dossier"'
Publikováno v:
Безопасность и риск фармакотерапии, Vol 12, Iss 3, Pp 331-340 (2024)
INTRODUCTION. Documents on the pharmacovigilance system of the marketing authorisation holder (MAH), including the Pharmacovigilance System Master File (PSMF) and the PSMF-based summary of the pharmacovigilance system (SPS), are a mandatory component
Externí odkaz:
https://doaj.org/article/425b4e69f60547eabdb9f68f05519747
Autor:
A. A. Spasov
Publikováno v:
Безопасность и риск фармакотерапии, Vol 11, Iss 3, Pp 246-251 (2023)
It is strategically critical to secure pharmaceutical independence for Russia by developing the industry using the latest achievements in science and technology. The development of nationally and internationally competitive medicines calls for the ha
Externí odkaz:
https://doaj.org/article/dd3aa4ee8df345779b73859ad50ebaa1
Publikováno v:
Ведомости Научного центра экспертизы средств медицинского применения, Vol 13, Iss 2-1, Pp 345-360 (2023)
Since 2021, the marketing authorisation (MA) of new medicinal products in the Russian Federation has been carried out according to the Rules of Marketing Authorisation and Assessment of Medicinal Products for Human Use that are implemented by Decisio
Externí odkaz:
https://doaj.org/article/f47b2f6762ee40a7a5a26df35d30e520
Publikováno v:
Разработка и регистрация лекарственных средств, Vol 11, Iss 4, Pp 133-138 (2022)
Introduction. New requirements for the registration of generic drugs after the entry of the Russian Federation into the Eurasian Economic Union (EAEU) and the signing of the Agreement on Common Principles and Rules for the Circulation of Medicinal Pr
Externí odkaz:
https://doaj.org/article/d8b6d93e09314d44add9d12539fc85d5
Autor:
E. M. Rychikhina
Publikováno v:
Ведомости Научного центра экспертизы средств медицинского применения, Vol 12, Iss 3, Pp 341-347 (2022)
The legislation of the Eurasian Economic Union (EAEU) includes all the necessary requirements and tools to implement a unified approach to preparing Module 1 of the electronic Common Technical Document (eCTD) for the concerned member states (CMSs). H
Externí odkaz:
https://doaj.org/article/bdd8364d4be54affb54fd215ec8332a6
Publikováno v:
Разработка и регистрация лекарственных средств, Vol 11, Iss 1, Pp 159-164 (2022)
Introduction. An important task for pharmaceutical manufacturers is to bring high quality, effective and safe medicines to the market. In the event that the country's resources are not enough, drugs that have been successfully registered in other cou
Externí odkaz:
https://doaj.org/article/aad5f9ff7a2246359f4c3d9ef50685bb
Publikováno v:
Разработка и регистрация лекарственных средств, Vol 10, Iss 2, Pp 155-161 (2021)
Introduction. One of the main business objectives of Russian pharmaceutical companies is export development. To obtain marketing authorization in countries with a good potential for business it is of greater importance to be competent in drugs regist
Externí odkaz:
https://doaj.org/article/6ea44726562441d98ea3052e1c783748
Autor:
I. V. Shulgina, O. A. Lobovikova, O. A. Voloh, O. V. Gromova, A. K. Nikiforov, A. V. Komissarov, V. A. Demchenko, A. S. Fes’kova, S. S. Galetova, N. P. Mironova, V. I. Pavlova
Publikováno v:
Разработка и регистрация лекарственных средств, Vol 9, Iss 1, Pp 109-114 (2020)
Introduction. The inevitable of post-registration variations due to the improvement of production processes and quality control related to the integration of the modern technological solutions, replacement of equipment, suppliers of raw, consumables
Externí odkaz:
https://doaj.org/article/11b816b11ba5412caa2da1c0ac166582
Autor:
V. A. Shevtsov, Yu. V. Olefir, V. A. Merkulov, V. P. Bondarev, I. N. Indikova, E. E. Evreinova, A. V. Rukavishnikov, L. M. Khantimirova, D. V. Gorenkov
Publikováno v:
Ведомости Научного центра экспертизы средств медицинского применения, Vol 9, Iss 1, Pp 41-48 (2019)
Externí odkaz:
https://doaj.org/article/f174a2d0d0d24a6da0c6fbc8e67b4f84