Pub Date : 2020-07-31DOI: 10.2174/2213476x06666191015114427
Pavan Deshpande, Rutuja Agawane, Sarath Chandra Tatikola, S. G. Vasantharaju
United States Food and Drug Administration (USFDA) is a federal agency functioning under United States Federal Executive Departments, which strives to regulate the food products and drug substances being manufactured or brought into US market, upholding Quality and Safety as prime goals. It takes care of its goals by inspecting firms which market products in the United States. It chalks out good manufacturing procedures for obtaining quality end-products. Based on inspections conducted and data collected thereby, those not abiding by rules shall be issued with Warning Letters and marketing license shall be cancelled for those who fail to justify the warning letter. This brings about discipline amongst manufacturers and sets a goal of quality that needs to be achieved to survive in market.
{"title":"US FDA Warning Letters of CAPA Violations: A Review","authors":"Pavan Deshpande, Rutuja Agawane, Sarath Chandra Tatikola, S. G. Vasantharaju","doi":"10.2174/2213476x06666191015114427","DOIUrl":"https://doi.org/10.2174/2213476x06666191015114427","url":null,"abstract":"\u0000\u0000United States Food and Drug Administration (USFDA) is a federal agency functioning\u0000under United States Federal Executive Departments, which strives to regulate the food products\u0000and drug substances being manufactured or brought into US market, upholding Quality and Safety\u0000as prime goals. It takes care of its goals by inspecting firms which market products in the United\u0000States. It chalks out good manufacturing procedures for obtaining quality end-products. Based on\u0000inspections conducted and data collected thereby, those not abiding by rules shall be issued with\u0000Warning Letters and marketing license shall be cancelled for those who fail to justify the warning\u0000letter. This brings about discipline amongst manufacturers and sets a goal of quality that needs to\u0000be achieved to survive in market.\u0000","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80462889","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Smoking has several consequences over the society and the economy at same time. Because of smoking smokers are reducing the life quality and life expectation too. That is the main cause of absolute socioeconomic inequity attributable to smoking. Objective: To characterize the absolute socioeconomic inequity attributable to smoking. Materials and methods: Were used several theorical methods as the inductive – deductive and the comparative too. As empirical method was used the bibliographic research. Results: Smoking is the main cause of the existence of this particular inequity form. That’s why to eliminate the absolute socioeconomic inequity attributable to smoking is necessary focus the attention in the reduction of the tobacco consumption intensity as main explicative variable for personal smoker demand of health services because of smoking. Conclusions: The absolute socioeconomic inequity attributable to smoking is showed by mortality and morbidity too. In both case the strategic to reduce the tobacco consumption must focus the attention as main way to control, reduce and eliminate the absolute socioeconomic inequity attributable to smoking
{"title":"The absolute socioeconomic inequity attributable to smoking","authors":"F. Hernández","doi":"10.31579/2693-4779/009","DOIUrl":"https://doi.org/10.31579/2693-4779/009","url":null,"abstract":"Background: Smoking has several consequences over the society and the economy at same time. Because of smoking smokers are reducing the life quality and life expectation too. That is the main cause of absolute socioeconomic inequity attributable to smoking. Objective: To characterize the absolute socioeconomic inequity attributable to smoking. Materials and methods: Were used several theorical methods as the inductive – deductive and the comparative too. As empirical method was used the bibliographic research. Results: Smoking is the main cause of the existence of this particular inequity form. That’s why to eliminate the absolute socioeconomic inequity attributable to smoking is necessary focus the attention in the reduction of the tobacco consumption intensity as main explicative variable for personal smoker demand of health services because of smoking. Conclusions: The absolute socioeconomic inequity attributable to smoking is showed by mortality and morbidity too. In both case the strategic to reduce the tobacco consumption must focus the attention as main way to control, reduce and eliminate the absolute socioeconomic inequity attributable to smoking","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90482022","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: An infectious disease caused by a novel coronavirus called COVID-19 has raged across the world since December 2019. The novel coronavirus first appeared in Wuhan, China, and quickly spread to Asia and now many countries around the world are affected by the epidemic. The deaths of many patients, including medical staff, caused social panic, media attention, and high attention from governments and world organizations. Today, with the joint efforts of the government, the doctors and all walks of life, the epidemic in Hubei Province has been brought under control, preventing its spread from affecting the lives of the people. Because of its rapid spread and serious consequences, this sudden novel coronary pneumonia epidemic has become an important social hot spot event. Through the analysis of the novel coronary pneumonia epidemic situation, we can also have a better understanding of sudden infectious diseases in the future, so that we can take more effective response measures, establish a truly predictable and provide reliable and sufficient information for prevention and control model. Methods: We establish different models according to the different developments of the epidemic situation, different time points, and different response measures taken by the government. To be specific, during the period of 2020.1.23-2020.2.7, the traditional SIR model is adopted; during the period of 2020.2.8-2020.3.30, according to the scientific research results, it was considered that the novel coronary pneumonia has a latent period, so in the later phase of epidemic development, the government has effectively isolated patients, thus we adopt the SEIQR model accordingly. During the period of 2020.3.31-2020.5.16, because more asymptomatic infected people were found, we use the SEIQLR model to fit. Finally, through a SEIR simulator, considering the susceptible number, the latent number, the infected number, the cured number, death number and other factors, we simulate the change of various numbers of people from the beginning to the next 180 days of novel coronary pneumonia. Findings: The results based on the analysis of differential equations and kinetic models show that through the prediction of the model established in the first phase, the epidemic situation of novel coronary pneumonia in Hubei Province was controlled at the end of March, which is in line with the actual situation. The rest of Hubei province, except for Wuhan, lifted control of the departure channel from 0:00 am on March 25, and Wuhan was also unblocked on April 8. Through the establishment of the second-phase model, it is found that the epidemic situation will reach its peak in mid-February. For example, the quarantine admission of the hospital declined after mid-February, which is inseparable from the measures to build square cabin hospitals in early February so that more and more patients can be admitted. The model established in the third phase shows that the epidemic had been comp
{"title":"Differential equation analysis on COVID-19(CRCT)","authors":"Bin Zhao","doi":"10.31579/2693-4779/006","DOIUrl":"https://doi.org/10.31579/2693-4779/006","url":null,"abstract":"Background: An infectious disease caused by a novel coronavirus called COVID-19 has raged across the world since December 2019. The novel coronavirus first appeared in Wuhan, China, and quickly spread to Asia and now many countries around the world are affected by the epidemic. The deaths of many patients, including medical staff, caused social panic, media attention, and high attention from governments and world organizations. Today, with the joint efforts of the government, the doctors and all walks of life, the epidemic in Hubei Province has been brought under control, preventing its spread from affecting the lives of the people. Because of its rapid spread and serious consequences, this sudden novel coronary pneumonia epidemic has become an important social hot spot event. Through the analysis of the novel coronary pneumonia epidemic situation, we can also have a better understanding of sudden infectious diseases in the future, so that we can take more effective response measures, establish a truly predictable and provide reliable and sufficient information for prevention and control model. Methods: We establish different models according to the different developments of the epidemic situation, different time points, and different response measures taken by the government. To be specific, during the period of 2020.1.23-2020.2.7, the traditional SIR model is adopted; during the period of 2020.2.8-2020.3.30, according to the scientific research results, it was considered that the novel coronary pneumonia has a latent period, so in the later phase of epidemic development, the government has effectively isolated patients, thus we adopt the SEIQR model accordingly. During the period of 2020.3.31-2020.5.16, because more asymptomatic infected people were found, we use the SEIQLR model to fit. Finally, through a SEIR simulator, considering the susceptible number, the latent number, the infected number, the cured number, death number and other factors, we simulate the change of various numbers of people from the beginning to the next 180 days of novel coronary pneumonia. Findings: The results based on the analysis of differential equations and kinetic models show that through the prediction of the model established in the first phase, the epidemic situation of novel coronary pneumonia in Hubei Province was controlled at the end of March, which is in line with the actual situation. The rest of Hubei province, except for Wuhan, lifted control of the departure channel from 0:00 am on March 25, and Wuhan was also unblocked on April 8. Through the establishment of the second-phase model, it is found that the epidemic situation will reach its peak in mid-February. For example, the quarantine admission of the hospital declined after mid-February, which is inseparable from the measures to build square cabin hospitals in early February so that more and more patients can be admitted. The model established in the third phase shows that the epidemic had been comp","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82798040","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Aging is inevitably associated with a large number of body functions including the mental health. In addition to that, heart function, emotions, moods etc. could be mentioned as the results of gradual aging. Such conditions are usually accompanied with increase in medications consumption and decline in quality of life. Though usually medical sciences study mental health conditions, sociology also needs to be applied to appraise the "cause and effect" of mental health. As life expectancy is globally increasing, more and more people are subject to mental disorders, Alzheimer's disorders, dementia, depression and many more, as the effects of aging extensively impact mental health. Therefore, under the conditions of rapid aging, geriatrics needs to be strengthened and improved as much as possible to safeguard mental health. However, structural changes in terms of biological, physical, psychological and chemical reactions which inevitably occur with aging, need prevention and appropriate medication, and other investments in long term, and if not, other vulnerabilities will inevitably appear.
{"title":"Inevitable aging and the resultant mental disorders In developing countries: a sociological appraisal","authors":"M. Sheykhi","doi":"10.31579/crct.2020/002","DOIUrl":"https://doi.org/10.31579/crct.2020/002","url":null,"abstract":"Aging is inevitably associated with a large number of body functions including the mental health. In addition to that, heart function, emotions, moods etc. could be mentioned as the results of gradual aging. Such conditions are usually accompanied with increase in medications consumption and decline in quality of life. Though usually medical sciences study mental health conditions, sociology also needs to be applied to appraise the \"cause and effect\" of mental health. As life expectancy is globally increasing, more and more people are subject to mental disorders, Alzheimer's disorders, dementia, depression and many more, as the effects of aging extensively impact mental health. Therefore, under the conditions of rapid aging, geriatrics needs to be strengthened and improved as much as possible to safeguard mental health. However, structural changes in terms of biological, physical, psychological and chemical reactions which inevitably occur with aging, need prevention and appropriate medication, and other investments in long term, and if not, other vulnerabilities will inevitably appear.","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74744791","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
A 06-month-old infant, born from a non-consanguineous marriage, with no notable pathological history, who consults for an asymptomatic nodular lesion of 1cm in diameter at the level of the orange-yellow vertex appeared since the age of 4 months, gradually increasing in size.
{"title":"Juvenile Xanthogranuloma: Rare Form of Histiocytosis: About 2 Cases","authors":"S. Benkirane","doi":"10.31579/2693-4779/008","DOIUrl":"https://doi.org/10.31579/2693-4779/008","url":null,"abstract":"A 06-month-old infant, born from a non-consanguineous marriage, with no notable pathological history, who consults for an asymptomatic nodular lesion of 1cm in diameter at the level of the orange-yellow vertex appeared since the age of 4 months, gradually increasing in size.","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88311211","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The Public Health services are closest related with the human develop. The strong relation between population health and labor productivity is determining the historical economic develop and the real capability to make sustainable the economic develop. Few sectors have an extensive and strong relation with the human develop as the Public Health. The health policies may insider over the whole population and can determine which population sector can access to the health services and the real dimension from the effective demand from these services too.
{"title":"Diploma course: “Health Economy tools for taking decisions”, a useful tool for health managers","authors":"F. Hernández","doi":"10.31579/crct.2020/010","DOIUrl":"https://doi.org/10.31579/crct.2020/010","url":null,"abstract":"The Public Health services are closest related with the human develop. The strong relation between population health and labor productivity is determining the historical economic develop and the real capability to make sustainable the economic develop. Few sectors have an extensive and strong relation with the human develop as the Public Health. The health policies may insider over the whole population and can determine which population sector can access to the health services and the real dimension from the effective demand from these services too.","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76038233","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction: As risk factor smoking means a social opportunity cost because of the whole goods and services didn´t obtained to satisfice the tobacco and cigarettes demand. While the tobacco and cigarettes spend is increasing these opportunity cost will be increasing too. Objective: To describe the tobacco and cigarettes spends in Cuba since 2013 to 2016. Materials and methods: Was made a descriptive and longitudinal research about the tobacco and cigarettes spends in Cuba from 2013 to 2016. Were utilized two rates: monthly per capita sales on cigarettes and tobaccos measured in pesos and monthly per capita sales on cigarettes and tobaccos respect to middle salary measured in percent. Theoric methods: Historic – Logic, Inductive – Deductive, Comparative and Analysis and Synthesis. Empiric methods: documental and bibliographic research and arithmetic calculus. All the statistic processing was in Microsoft Excel 2007. Results: The personal spend on cigarettes and tobaccos from 2013 to 2016 shows a stable and defined structure. Conclusions: Havana, Santiago de Cuba provinces and the Special Municipality Isla de la Juventud were the Cuban regions showed consumption rate higher than the national middle.
{"title":"Personal spend on cigarettes and tobaccos in Cuba from 2013 to 2016.","authors":"F. Hernández","doi":"10.31579/crct.2020/011","DOIUrl":"https://doi.org/10.31579/crct.2020/011","url":null,"abstract":"Introduction: As risk factor smoking means a social opportunity cost because of the whole goods and services didn´t obtained to satisfice the tobacco and cigarettes demand. While the tobacco and cigarettes spend is increasing these opportunity cost will be increasing too. Objective: To describe the tobacco and cigarettes spends in Cuba since 2013 to 2016. Materials and methods: Was made a descriptive and longitudinal research about the tobacco and cigarettes spends in Cuba from 2013 to 2016. Were utilized two rates: monthly per capita sales on cigarettes and tobaccos measured in pesos and monthly per capita sales on cigarettes and tobaccos respect to middle salary measured in percent. Theoric methods: Historic – Logic, Inductive – Deductive, Comparative and Analysis and Synthesis. Empiric methods: documental and bibliographic research and arithmetic calculus. All the statistic processing was in Microsoft Excel 2007. Results: The personal spend on cigarettes and tobaccos from 2013 to 2016 shows a stable and defined structure. Conclusions: Havana, Santiago de Cuba provinces and the Special Municipality Isla de la Juventud were the Cuban regions showed consumption rate higher than the national middle.","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88274460","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction: As risk factor smoking means a social opportunity cost because of the whole goods and services didn´t obtained to satisfice the tobacco and cigarettes demand. While the tobacco and cigarettes spend is increasing these opportunity cost will be increasing too. Objective: To describe the tobacco and cigarettes spends in Cuba since 2013 to 2016. Materials and methods: Was made a descriptive and longitudinal research about the tobacco and cigarettes spends in Cuba from 2013 to 2016. Were utilized two rates: monthly per capita sales on cigarettes and tobaccos measured in pesos and monthly per capita sales on cigarettes and tobaccos respect to middle salary measured in percent. Theoric methods: Historic – Logic, Inductive – Deductive, Comparative and Analysis and Synthesis. Empiric methods: documental and bibliographic research and arithmetic calculus. All the statistic processing was in Microsoft Excel 2007. Results: The personal spend on cigarettes and tobaccos from 2013 to 2016 shows a stable and defined structure. Conclusions: Havana, Santiago de Cuba provinces and the Special Municipality Isla de la Juventud were the Cuban regions showed consumption rate higher than the national middle.
{"title":"Personal spend on cigarettes and tobaccos in Cuba from 2013 to 2016","authors":"F. Hernández","doi":"10.31579/2693-4779/011","DOIUrl":"https://doi.org/10.31579/2693-4779/011","url":null,"abstract":"Introduction: As risk factor smoking means a social opportunity cost because of the whole goods and services didn´t obtained to satisfice the tobacco and cigarettes demand. While the tobacco and cigarettes spend is increasing these opportunity cost will be increasing too. Objective: To describe the tobacco and cigarettes spends in Cuba since 2013 to 2016. Materials and methods: Was made a descriptive and longitudinal research about the tobacco and cigarettes spends in Cuba from 2013 to 2016. Were utilized two rates: monthly per capita sales on cigarettes and tobaccos measured in pesos and monthly per capita sales on cigarettes and tobaccos respect to middle salary measured in percent. Theoric methods: Historic – Logic, Inductive – Deductive, Comparative and Analysis and Synthesis. Empiric methods: documental and bibliographic research and arithmetic calculus. All the statistic processing was in Microsoft Excel 2007. Results: The personal spend on cigarettes and tobaccos from 2013 to 2016 shows a stable and defined structure. Conclusions: Havana, Santiago de Cuba provinces and the Special Municipality Isla de la Juventud were the Cuban regions showed consumption rate higher than the national middle.","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74124138","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-07-14DOI: 10.2174/2213476x07999200309141640
K. P. Satish, S. Nair
{"title":"Coronavirus (COVID-19) Outbreak: A Test of Viral Muscle Versus the Human Tussle","authors":"K. P. Satish, S. Nair","doi":"10.2174/2213476x07999200309141640","DOIUrl":"https://doi.org/10.2174/2213476x07999200309141640","url":null,"abstract":"","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73366835","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-07-08DOI: 10.2174/2213476x07666200708105237
Kapil Pihwal, Neelam Pawar, Sheikh Aamir, M. S. Alam, Vikas Rathee
The CIS region has a potential market for India. The registration of the drug products in CIS regions is a challenging task because these countries have no harmonized regulatory organization. The CIS region includes 12 countries such as Russia, Kyrgyzstan, Ukraine, Uzbekistan, Kazakhstan, Tajikistan, Turkmenistan, Armenia, Azerbaijan, Belarus, Georgia and Moldova, which require different regulatory guidelines for medicinal product registration as per their FDA guidelines. The different guidelines for the same region become a challenging task for the manufacturer and exporter. The registration of the same product for different countries of CIS is not possible with the same dossier due to the lack of their regulatory harmonization. These countries obey their country-specific dossier format, so to target these market manufacturers and exporters needs to submit different dossier documents for different countries. But Ukraine and Kazakhstan have harmonization and it varies in Uzbekistan and Tajikistan. Ukraine and Kazakhstan are also imposing strict rules and expecting USFDA level documents for approval. The overall conclusion is that harmonization in CIS is highly imbalanced, which affects both time and cost for product registration. Harmonization is the need of the era for easy product registration, and it will be beneficial for the manufacturer, regulator, importer, exporter, and to access medicines of high public health value.
{"title":"A Comprehensive Review of Regulatory Requirements and Registration Process of Pharmaceutical Drug Products in CIS Countries","authors":"Kapil Pihwal, Neelam Pawar, Sheikh Aamir, M. S. Alam, Vikas Rathee","doi":"10.2174/2213476x07666200708105237","DOIUrl":"https://doi.org/10.2174/2213476x07666200708105237","url":null,"abstract":"\u0000\u0000The CIS region has a potential market for India. The registration of the\u0000drug products in CIS regions is a challenging task because these countries have no harmonized\u0000regulatory organization. The CIS region includes 12 countries such as Russia, Kyrgyzstan,\u0000Ukraine, Uzbekistan, Kazakhstan, Tajikistan, Turkmenistan, Armenia, Azerbaijan, Belarus, Georgia\u0000and Moldova, which require different regulatory guidelines for medicinal product registration\u0000as per their FDA guidelines. The different guidelines for the same region become a challenging\u0000task for the manufacturer and exporter. The registration of the same product for different countries\u0000of CIS is not possible with the same dossier due to the lack of their regulatory harmonization.\u0000These countries obey their country-specific dossier format, so to target these market manufacturers\u0000and exporters needs to submit different dossier documents for different countries. But Ukraine\u0000and Kazakhstan have harmonization and it varies in Uzbekistan and Tajikistan. Ukraine and Kazakhstan\u0000are also imposing strict rules and expecting USFDA level documents for approval.\u0000\u0000\u0000\u0000The overall conclusion is that harmonization in CIS is highly imbalanced, which affects\u0000both time and cost for product registration. Harmonization is the need of the era for easy\u0000product registration, and it will be beneficial for the manufacturer, regulator, importer, exporter,\u0000and to access medicines of high public health value.\u0000","PeriodicalId":8525,"journal":{"name":"Applied Clinical Research, Clinical Trials and Regulatory Affairs","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73406366","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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