Considerations regarding demonstration of efficacy and safety of homeopathic medicines
The article analyses the regulatory and legal framework for medicines evaluation in the Russian Federation and abroad, as well as guidelines, scientific literature and practical experience to justify criteria for evaluation of efficacy and safety of homeopathic medicines. When selecting appropriate...
Saved in:
| Main Authors: | , , , |
|---|---|
| Format: | Article |
| Language: | Russian |
| Published: |
Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)
2018-02-01
|
| Series: | Регуляторные исследования и экспертиза лекарственных средств |
| Subjects: | |
| Online Access: | https://www.vedomostincesmp.ru/jour/article/view/126 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| Summary: | The article analyses the regulatory and legal framework for medicines evaluation in the Russian Federation and abroad, as well as guidelines, scientific literature and practical experience to justify criteria for evaluation of efficacy and safety of homeopathic medicines. When selecting appropriate evaluation criteria the authors took into account specificity of homeopathic medicines composition and dosage form formulation, specific characteristics of pharmaceutical substances and therapeutic action, as well as known limitations on the use of standard test methods. The key criteria for homeopathic medicines evaluation are: compliance of the substance quality and the drug production technology with corresponding pharmacopoeial requirements, substantiation of the drug composition safety, and confirmation of the proposed efficacy and safety by the evidence-based pre-clinical and clinical programme. |
|---|---|
| ISSN: | 3034-3062 3034-3453 |