Biomedical Cell Products or High-Tech Drugs?
Marketing authorisation is a prerequisite for the use of drugs in medical practice in the Russian Federation. The marketing authorisation procedure is applicable to ordinary medicinal products. As for advanced therapy medicinal products containing viable human cells — there are currently two authori...
Main Authors: | V. A. Merkulov, E. V. Melnikova |
---|---|
Format: | Article |
Language: | Russian |
Published: |
Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
2019-06-01
|
Series: | Биопрепараты: Профилактика, диагностика, лечение |
Subjects: | |
Online Access: | https://www.biopreparations.ru/jour/article/view/219 |
Similar Items
-
Methodological aspects of the development of product files for biomedical cell products
by: E. V. Melnikova, et al.
Published: (2021-07-01) -
Clinical trials for cellular therapy products: conclusions reached by foreign regulatory bodies
by: E. V. Melnikova, et al.
Published: (2020-07-01) -
Justification of Methodological Approaches to Identification Testing of Biomedical Cell Products
by: E. V. Melnikova, et al.
Published: (2019-03-01) -
Treatment of Genetic Diseases: Current Trends in the Development of Biomedical Cell Products
by: O. A. Rachinskaya, et al.
Published: (2019-12-01) -
STUDY APPROACHES TO DEFINITION OF THE PRODUCT IN THE PRODUCTION OF HIGH-TECH
by: E. P. Garina, et al.
Published: (2017-09-01)