Comparative analysis of Russian and International requirements for establishing the interchangeability of generic medicinal products

2016 ◽  
pp. 6-12
Author(s):  
A.A. Chernyshkova ◽  
◽  
E.O. Trofimova ◽  
Keyword(s):  
Comparative Analysis ◽  
Medicinal Products

scholarly journals Order of medicines rationing with the provision of qualified surgical help to military servicing

2019 ◽  
pp. 20-30
Author(s):  
O. V. Bielyozorova ◽  
O. P. Shmatenko
Keyword(s):  
Nervous System ◽  
Comparative Analysis ◽  
Medical Care ◽  
Medical Service ◽  
Blood System ◽  
Military Hospital ◽  
Medicinal Products ◽  
Surgical Assistance ◽  
Care And Treatment ◽  
The Military

The standardization of medicines, taking into account the considerable experience of the military medical service, is a promising direction for improving the medical supply of the health facilities of the Ministry of Defense of Ukraine and provides medical provision in accordance with established norms in order to fully and timely meet the needs of the medical service in the Ministry of Health for the provision of quality and effective medical care and treatment of wounded and sick. The purpose of the study was the rationale of the method of valuation and a comparative analysis of the proposed norms for supplying medicines to a military hospital and a military mobile hospital offered in the treatment of surgical personnel. A comprehensive analysis of the medical treatment of soldiers in the surgical section of the military hospital and the military mobile hospital was conducted (345 and 202 persons, respectively), the normative method of the proposed nomenclature and the number of drugs for the provision of qualified surgical care in the conditions of the military hospital and the military mobile hospital. The nomenclature of medicines under the international non-proprietary names included in the proposed list of norms for the supply of medicinal products and is intended for servicemen of a surgical profile for the needs of military hospitals and military mobile hospitals is 147 and 130 titles of medicines, respectively. In the conditions of the military hospital in the species diversity, the most represented groups are medicinal products that affect the blood system and hemopoiesis (19%), drugs that affect the nervous system (16%), antimicrobials for systemic use (15%); in the conditions of a military mobile hospital ‒ medicines affecting the blood system and hemopoiesis (23 titles), in the second place drugs affecting the nervous system (21 titles), the third means affecting the digestive system and path (19 titles). Thus, a comparative analysis of the proposed fragment of the delivery of medicines for the needs of the military hospital and the military mobile hospital with approved Temporary Settlement of Medical Assets for the provision of medical care and treatment of wounded and patients for a special period demonstrated the conformity of the nomenclature of drugs to 41% (68 INN medicines for provision of qualified surgical assistance from 167 INN medicines for providing qualified medical aid).

Comparative analysis of the effectiveness of medicinal products for the laser wounds regeneration

2020 ◽  
Vol 19 (1) ◽  
pp. 105
Author(s):  
T. N. Korolkova ◽  
M. A. Ignatyuk ◽  
I. A. Shepilova ◽  
E. V. Kruglik
Keyword(s):  
Comparative Analysis ◽  
Medicinal Products

Comparative analysis of the scope of European Union paediatric investigation plans with corresponding orphan designations

2017 ◽  
Vol 103 (5) ◽  
pp. 427-430 ◽  
Author(s):  
Andrea Ecker ◽  
Segundo Mariz ◽  
Frauke Naumann-Winter ◽  
Koenraad Norga ◽  
Ingeborg Barisic ◽  
...  
Keyword(s):  
European Union ◽  
Comparative Analysis ◽  
Rare Diseases ◽  
Market Forces ◽  
The European Union ◽  
Medicinal Products ◽  
Paediatric Investigation Plan ◽  
Pharmaceutical Development ◽  
Orphan Medicinal Products ◽  
Small Patient

BackgroundMarket forces may not be sufficient to stimulate research and development of medicines for small patient populations, such as children and patients with rare diseases. Both the European Union Orphan and Paediatric Regulations were introduced to address the unmet public health needs of these smaller patient populations through the use of incentives, rewards and obligations. Developers for new medicines for rare diseases must agree a paediatric investigation plan (PIP) or waiver with the European Medicines Agency’s (EMA) Paediatric Committee (PDCO), and can also apply for an orphan designation (OD) from the EMA’s Committee of Orphan Medicinal Products (COMP). The scope of both the OD and the PIP (or waiver) is defined by the agreed condition.ObjectivesThe aim of this study was to analyse the approach of PDCO and COMP in defining the appropriate condition for a PIP or OD, respectively, in order to investigate potential challenges in the paediatric development of orphan medicines which have to meet the requirements of both legislations.MethodsA comparative analysis of PIP conditions and OD conditions was performed for medicines that have been reviewed by both Committees.ResultsWe found that in the substantial majority of cases there is no divergence between the conclusions of COMP and PDCO with regard to the condition for which a medicine is to be developed.ConclusionThese findings demonstrate that a collaborative approach allows both Regulations to work synergistically to foster pharmaceutical development for rare diseases in childhood.

scholarly journals Determination of Anthracene Derivatives in Herbal Medicines

2021 ◽  
Vol 11 (2) ◽  
pp. 104-114
Author(s):  
O. V. Evdokimova ◽  
A. V. Beketova ◽  
M. N. Lyakina
Keyword(s):  
Comparative Analysis ◽  
Herbal Medicines ◽  
Quality Standards ◽  
Test Methods ◽  
Medicinal Products ◽  
Herbal Medicinal Products ◽  
Herbal Preparations ◽  
Anthracene Derivatives ◽  
Herbal Medicinal

The relevance of this study stems from the need for alignment of test methods used for identification and assay of anthracene derivatives in herbal preparations and herbal medicinal products. The aim of the study was to analyse Russian and international quality standards and to identify the most specific and sensitive test methods that could be used for herbal medicines containing anthracene derivatives. The comparative analysis of requirements in the Identification, Determination of major classes of bioactive compounds, and Assay parts of the Russian and foreign pharmacopoeial monographs for herbal preparations and herbal medicinal products containing anthracene derivatives, demonstrated that the main test method used for identification is thin layer chromatography, while assays most often rely on spectrophotometry. The so-called “consistent standardisation” principle is implemented in the Russian quality standards as regards alignment of methods used for anthracene derivative determination in herbal preparations (i.e. active pharmaceutical ingredients, APIs) and herbal medicinal products containing these APIs. The comparative analysis of requirements in the Russian and foreign quality standards for herbal medicines containing anthracene derivatives demonstrated the need for elaboration of two general chapters: Qualitative analysis of anthracene derivatives in herbal medicines and Quantitative analysis of anthracene derivatives in herbal medicines.

scholarly journals The Impact of Reimbursement Practices on the Pharmaceutical Market for Off-Patent Medicines in Slovakia

2021 ◽  
Vol 12 ◽  
Author(s):  
Tomas Tesar ◽  
Peter Golias ◽  
Lucia Masarykova ◽  
Paweł Kawalec ◽  
András Inotai
Keyword(s):  
Comparative Analysis ◽  
Generic Drugs ◽  
European Medicines Agency ◽  
Medicinal Products ◽  
Generic Medicines ◽  
Patent Medicines ◽  
Reference Pricing ◽  
External Reference ◽  
The Impact ◽  
Visegrad Group

Background: The aim of this study was to investigate the impact of selected legislative initiatives and their implementation for off-patent medicinal products in Slovakia compared with the rest of the Visegrád Group (V4 countries).Methods: We analyzed the development of applications for the reimbursement of generic and biosimilar drugs. Particular emphasis was placed on a) the availability and penetration of biosimilars from 2006 to 2020 in Slovakia, b) a comparative analysis of biosimilars in V4 countries based on the national reimbursement lists of medicinal products for August 2021. Data relating to the sales of generic and biosimilar medicines in Czechia, Hungary, Poland, and Slovakia were based on the IQVIA MIDAS MAT July 2021.Results: The number of applications for the reimbursement of generic drugs decreased from 296 in 2016 to 165 in 2020. In financial terms, the sales of generic medicines in Slovakia increased from 21.7% in 2015 to 22.3% in 2020. Over the same period, the sales of generic drugs in Poland fell from 40.4% in 2015 to 35.0% in 2020, from 26.2 to 22.1% in Hungary, and from 29.6 to 20.4% in Czechia. When considering the 66 biosimilars registered by the European Medicines Agency 38 drugs (58%) were available on the Slovak market as of August 1, 2021; this compared to 32 drugs (48%) in Poland, 38 drugs (58%) in Hungary, and 40 drugs (61%) in Czechia. In financial terms, the sales of biosimilars in Slovakia increased from 0.94% in 2015 to 2.00% in 2020. Over the same period, the sales of biosimilars in Poland increased from 0.59% in 2015 to 1.29% in 2020, from 0.72 to 2.23% in Hungary, and from 0.76 to 2.15% in Czechia.Conclusion: To intensify the use of generic and biosimilar medicines, we suggest the comprehensive re-evaluation of combinations of the three-threshold entry, the amount of mandatory price reductions, and external reference pricing requirements (as the average of the three lowest prices among the official prices of a medicinal product in other Member States) for generic and biosimilar drugs. We also suggest cancellation of the exception from the fixed co-payment of the insured.

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