Back to Search
Start Over
Planning a Programme of Pre-authorisation Clinical Trials of Medicines for the Treatment of Chronic Hepatitis C
- Source :
- Ведомости Научного центра экспертизы средств медицинского применения, Vol 9, Iss 1, Pp 6-13 (2019)
- Publication Year :
- 2019
- Publisher :
- SCEEMP, 2019.
-
Abstract
- In 2016 the WHO Assembly defined a global strategy to combat viral hepatitis viruses, which seeks to eliminate these infections by 2030. The most important goals of this programme, adopted by 194 countries, are to reduce the incidence of viral hepatitis by 90 % and mortality rates – by 65 % as compared to the levels observed in 2016. Therefore, there is an obvious need for development of medicines for the treatment of chronic hepatitis C. The aim of the present paper was to determine basic approaches to planning pre-authorisation clinical trials for the main groups of medicines for the treatment of chronic hepatitis C. The paper summarises the current trends in the treatment of chronic hepatitis C; it lists medicines with direct antiviral effect that are currently registered in the Russian Federation, as well as interferon-free and interferon-containing regimens for the treatment of this disease. The authors examined the current requirements in force in the Russian Federation, namely: the Federal Law No. 61-FZ «On circulation of medicines» dated April 12, 2010, the Guideline on Evaluation of Medicinal Products, the Clinical Recommendations for Diagnosis and Treatment of Adult Patients with Hepatitis C, as well as recommendations of the European Medicines Agency and the Food and Drug Administration in order to analyse the planning of programmes of pre-authorisation clinical trials of interferon alfa products and direct antivirals.
- Subjects :
- Medicine (General)
medicine.medical_specialty
interferon-containing regimens
interferon-free regimens
interferon alfa products
Disease
01 natural sciences
R5-920
medicine
Intensive care medicine
Interferon alfa
pre-authorisation clinical trials
010405 organic chemistry
business.industry
Incidence (epidemiology)
Mortality rate
direct antivirals
Hepatitis C
Guideline
medicine.disease
0104 chemical sciences
Clinical trial
010404 medicinal & biomolecular chemistry
chronic hepatitis c
business
Viral hepatitis
medicine.drug
Subjects
Details
- ISSN :
- 26191172 and 19912919
- Volume :
- 9
- Database :
- OpenAIRE
- Journal :
- The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products
- Accession number :
- edsair.doi.dedup.....3d6ac96082f935e863dde7b194423133
- Full Text :
- https://doi.org/10.30895/1991-2919-2019-9-1-6-13