Pub Date : 2021-02-08DOI: 10.1177/1741134320987866
Pooja Rathee, Swagatika Tripathy, S. Khatter, BP Patra, P. Murthy, H. Dureja
Purpose 505(b) (2) application is one of the advantageous ways of regulatory submission. This submission approach can lead to fast-track approval for wide-ranging products, exclusively for those that exemplify a limited change from formerly approved drug. Safety and efficacy evidence in terms of non-clinical and clinical portion of the Reference Listed Drug (RLD), are trusted upon. Additionally, supplementary data essentially required to establish comparability with the RLD, are presented in the dossier. Methods This retrospective analysis is to understand the FDA's expectations and avoid errors in terms of data support approval for a new product submitted under the 505 (b) (2) route. The current script is an analysis on how to architect 505(b) (2) regulatory strategy by developing a different set of documents/information. Results The ultimate goal of this review is to allow drug developers to easily navigate through various 505 (b) (2) submissions and defense strategies for registration processes available to the new drug manufacturers and to understand an effective, safer filing route by facilitating early market launch with a prospect of lower cost. Conclusion Before considering option 505 (b) (2), general companies should have a good understanding of product’s potential productivity, scalability, patent infringement, expensive clinical studies and/or non-clinical studies to appropriately strategize scientific and commercial opportunities. This leverage will potentially quicken the development program and will definitely lower the clinical and regulatory risk of new product entrants.
{"title":"505(b) (2) - A smart pathway to differentiate from competitive, low margin environment of generics","authors":"Pooja Rathee, Swagatika Tripathy, S. Khatter, BP Patra, P. Murthy, H. Dureja","doi":"10.1177/1741134320987866","DOIUrl":"https://doi.org/10.1177/1741134320987866","url":null,"abstract":"Purpose 505(b) (2) application is one of the advantageous ways of regulatory submission. This submission approach can lead to fast-track approval for wide-ranging products, exclusively for those that exemplify a limited change from formerly approved drug. Safety and efficacy evidence in terms of non-clinical and clinical portion of the Reference Listed Drug (RLD), are trusted upon. Additionally, supplementary data essentially required to establish comparability with the RLD, are presented in the dossier. Methods This retrospective analysis is to understand the FDA's expectations and avoid errors in terms of data support approval for a new product submitted under the 505 (b) (2) route. The current script is an analysis on how to architect 505(b) (2) regulatory strategy by developing a different set of documents/information. Results The ultimate goal of this review is to allow drug developers to easily navigate through various 505 (b) (2) submissions and defense strategies for registration processes available to the new drug manufacturers and to understand an effective, safer filing route by facilitating early market launch with a prospect of lower cost. Conclusion Before considering option 505 (b) (2), general companies should have a good understanding of product’s potential productivity, scalability, patent infringement, expensive clinical studies and/or non-clinical studies to appropriately strategize scientific and commercial opportunities. This leverage will potentially quicken the development program and will definitely lower the clinical and regulatory risk of new product entrants.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"9 1","pages":"183 - 194"},"PeriodicalIF":0.0,"publicationDate":"2021-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74786157","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 : 2021-02-03DOI: 10.1177/17411343211055895
R. Milchior, S. Charbonnel
Compiled and written by SCP Herald Herald Avocats is a French law firm involved in intellectual property law, pharmaceutical law and European Union law that provides services to healthcare, biotech and pharmaceutical companies. This section is intended to be a synopsis of recent developments and is not intended to be all comprehensive. If any (issue) information referred to in this section is to be relied upon, specific advice should be sought. Please contact the Editor: Richard Milchior and Séverine Charbonnel SCP Herald 91 rue du Faubourg Saint Honore 75008 Paris France Tel: +33(0)1 53 43 15 15 Fax: +33(0) 1 53 43 15 00 Email: r.milchior@herald-avocats.com
Herald Avocats是一家法国律师事务所，涉及知识产权法、制药法和欧盟法，为医疗保健、生物技术和制药公司提供服务。本节旨在简要介绍最近的发展情况，并不打算包罗万象。如果要依赖本节中提及的任何(问题)信息，应寻求具体建议。请联系编辑:Richard Milchior和ssamverine Charbonnel SCP Herald 91 rue du Faubourg Saint Honore 75008法国巴黎电话:+33(0)1 53 43 15 15传真:+33(0)1 53 43 15 15电子邮件:r.milchior@herald-avocats.com
{"title":"Pharmaceutical; Trademark; Patents; News","authors":"R. Milchior, S. Charbonnel","doi":"10.1177/17411343211055895","DOIUrl":"https://doi.org/10.1177/17411343211055895","url":null,"abstract":"Compiled and written by SCP Herald Herald Avocats is a French law firm involved in intellectual property law, pharmaceutical law and European Union law that provides services to healthcare, biotech and pharmaceutical companies. This section is intended to be a synopsis of recent developments and is not intended to be all comprehensive. If any (issue) information referred to in this section is to be relied upon, specific advice should be sought. Please contact the Editor: Richard Milchior and Séverine Charbonnel SCP Herald 91 rue du Faubourg Saint Honore 75008 Paris France Tel: +33(0)1 53 43 15 15 Fax: +33(0) 1 53 43 15 00 Email: r.milchior@herald-avocats.com","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"44 1","pages":"225 - 231"},"PeriodicalIF":0.0,"publicationDate":"2021-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87155502","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 : 2021-01-26DOI: 10.1177/1741134321993182
O. Gurgula, W. H. Lee
The COVID-19 pandemic has exposed the fundamental flaws in the current system of medical innovation and access to medicines, which require urgent attention from the global community. This is prompted by the experience of the past decades, which has proven that this system was ineffective in securing adequate access to medicines for all. The understanding of the deficiencies of the existing system is crucial today, as it may help to design effective approaches for improving access. This article will also consider mechanisms that may be implemented by governments for the protection of public health. These include short-term mechanisms, such as compulsory licensing and government use, as well as the long-term design of a new innovation model, including state-coordinated research of medicines and open innovation. The current system should be reconsidered to ensure the prompt development of COVID-19 therapy accessible to everyone and full preparedness for the pandemics of the future.
{"title":"COVID-19, IP and access: Will the current system of medical innovation and access to medicines meet global expectations?","authors":"O. Gurgula, W. H. Lee","doi":"10.1177/1741134321993182","DOIUrl":"https://doi.org/10.1177/1741134321993182","url":null,"abstract":"The COVID-19 pandemic has exposed the fundamental flaws in the current system of medical innovation and access to medicines, which require urgent attention from the global community. This is prompted by the experience of the past decades, which has proven that this system was ineffective in securing adequate access to medicines for all. The understanding of the deficiencies of the existing system is crucial today, as it may help to design effective approaches for improving access. This article will also consider mechanisms that may be implemented by governments for the protection of public health. These include short-term mechanisms, such as compulsory licensing and government use, as well as the long-term design of a new innovation model, including state-coordinated research of medicines and open innovation. The current system should be reconsidered to ensure the prompt development of COVID-19 therapy accessible to everyone and full preparedness for the pandemics of the future.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"73 1","pages":"61 - 70"},"PeriodicalIF":0.0,"publicationDate":"2021-01-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79653685","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 : 2021-01-20DOI: 10.1177/1741134320988324
Tarif Hussian, M. Choudhary, V. Budhwar, G. Saini
COVID-19 pandemic has shattered the global health economy. Advertisers take advantage of fear and emotions in society due to the pandemic outbreak. Rumors spread rapidly through digital media are another form of misinformation. False claims advertising is a combination of misinformation and disinformation that is fatal and moral deterioration to global society. True information is of central importance in society to avoid false information during the pandemic to control unexpected damage. Without scientific and evidence-based information about all kinds of products and services through advertisements on social media people often use to shift social attitudes. Society always relies on national and harmonious international regulatory bodies during any kind of epidemic and disaster credibility for true information. In most of the Countries, false advertisements are illegal. Countries need to continuously introduce a strict regulatory framework with the Suo Motu surveillance system to breach false advertisements on all media platforms about health care products and services.
{"title":"COVID-19 pandemic: An era of myths and misleading advertisements","authors":"Tarif Hussian, M. Choudhary, V. Budhwar, G. Saini","doi":"10.1177/1741134320988324","DOIUrl":"https://doi.org/10.1177/1741134320988324","url":null,"abstract":"COVID-19 pandemic has shattered the global health economy. Advertisers take advantage of fear and emotions in society due to the pandemic outbreak. Rumors spread rapidly through digital media are another form of misinformation. False claims advertising is a combination of misinformation and disinformation that is fatal and moral deterioration to global society. True information is of central importance in society to avoid false information during the pandemic to control unexpected damage. Without scientific and evidence-based information about all kinds of products and services through advertisements on social media people often use to shift social attitudes. Society always relies on national and harmonious international regulatory bodies during any kind of epidemic and disaster credibility for true information. In most of the Countries, false advertisements are illegal. Countries need to continuously introduce a strict regulatory framework with the Suo Motu surveillance system to breach false advertisements on all media platforms about health care products and services.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"21 1","pages":"49 - 54"},"PeriodicalIF":0.0,"publicationDate":"2021-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74462704","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 : 2020-11-08DOI: 10.1177/1741134320972155
A. Bana, P. Mehta
Drugs that are procured from living cells and are used to treat acute and chronic diseases are called biologics, whereas biosimilars are the drugs which are highly similar but not identical to the original reference product. The main advantage of these drugs is that they are highly targeted with great therapeutic activity and can be used for multiple indications. Despite all the advantages biologics are still extremely costly. The main purpose of developing and introducing biosimilars was and is to increase market competition leading to a decrease in the cost of the biologics. However, until now the cost of the treatment has not decreased in the US market because there are many barriers to the entry of biosimilar in the US market which are discussed in this article. In this article, we argue that the barrier or hurdle in the US market entry of the biosimilars is not only limited to patent protection or exclusivity but other less discussed barriers are also there which are to be discussed. Due to these barriers till June 10, 2020, only 9 biosimilars are available commercially in the US market out of the 27 biosimilars approved for marketing by the U.S. Food and Drug Administration (FDA). We argue that the introduction of these biosimilars in the US market is essential for increasing market competition and thus decreasing the overall treatment cost for both the government and the payers. In this article, we are also providing perspective on the possible solutions to reduce these barriers and to encourage the entry of biosimilar in the US market.
{"title":"Recognizing barriers to entry of biosimilars in the United States market and highlighting the solutions","authors":"A. Bana, P. Mehta","doi":"10.1177/1741134320972155","DOIUrl":"https://doi.org/10.1177/1741134320972155","url":null,"abstract":"Drugs that are procured from living cells and are used to treat acute and chronic diseases are called biologics, whereas biosimilars are the drugs which are highly similar but not identical to the original reference product. The main advantage of these drugs is that they are highly targeted with great therapeutic activity and can be used for multiple indications. Despite all the advantages biologics are still extremely costly. The main purpose of developing and introducing biosimilars was and is to increase market competition leading to a decrease in the cost of the biologics. However, until now the cost of the treatment has not decreased in the US market because there are many barriers to the entry of biosimilar in the US market which are discussed in this article. In this article, we argue that the barrier or hurdle in the US market entry of the biosimilars is not only limited to patent protection or exclusivity but other less discussed barriers are also there which are to be discussed. Due to these barriers till June 10, 2020, only 9 biosimilars are available commercially in the US market out of the 27 biosimilars approved for marketing by the U.S. Food and Drug Administration (FDA). We argue that the introduction of these biosimilars in the US market is essential for increasing market competition and thus decreasing the overall treatment cost for both the government and the payers. In this article, we are also providing perspective on the possible solutions to reduce these barriers and to encourage the entry of biosimilar in the US market.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"30 1","pages":"122 - 129"},"PeriodicalIF":0.0,"publicationDate":"2020-11-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74404433","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 : 2020-11-05DOI: 10.1177/1741134320962532
Stephen M. Roylance
{"title":"US Supreme Court further strengthens IPR’s","authors":"Stephen M. Roylance","doi":"10.1177/1741134320962532","DOIUrl":"https://doi.org/10.1177/1741134320962532","url":null,"abstract":"","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"2 1","pages":"171 - 173"},"PeriodicalIF":0.0,"publicationDate":"2020-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75655507","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 : 2020-10-07DOI: 10.1177/1741134320962843
K. Osemene, M. Ihekoronye, A. Lamikanra
Background Although generic medicines are used extensively in Nigeria information from community pharmacists about these drugs are scanty and therefore inadequate. This is why this study has been designed to bridge the knowledge gap, attitudes, as well as the perception and practice of community pharmacists about generic medicines in Nigeria. Method A questionnaire-guided cross-sectional survey was used to collect data from 380 community pharmacists who were randomly selected from community pharmacies between April and June 2019 in Southwestern Nigeria. Data generated in the course of this study was analysed with the Statistical Package for Social Sciences version 18. Descriptive statistics were used to summarize data. Chi-square was used to test proportions and to determine associations between categorical variables. Pearson’s Correlation Coefficient was used to determine correlation between dependent variables. Result Mean knowledge score of community pharmacists about generic medicines(GM) was 5.6 ± 2.9 out of a total maximum score of 10. Results showed that 47.9% of respondents had poor knowledge, 27.6% average knowledge and 24.5% good knowledge about GM. Knowledge was significantly associated (p = .000) with all demographic characteristics except professional qualifications. A majority (89%) of the respondents were of the view that patients need more explanations when GMs are dispensed to them. In addition, 90.3% of the respondents were of the opinion that GM will improve access to medicine because they are cheaper and easily affordable. About 93% practice generic substitution without consulting prescribing physicians. Furthermore, 85% of the respondents claim they stock mainly GMs. Conclusion Community pharmacists in Nigeria had a positive attitude, perception and practice about GM, but exhibited sub-optimal knowledge in understanding issues concerning generic medicines. It is concluded that there is the need for continuous training and education to enhance professional knowledge of pharmacists in the area of GM substitution.
{"title":"Knowledge, attitudes, perceptions and practices of community pharmacists about generic medicine in Nigeria","authors":"K. Osemene, M. Ihekoronye, A. Lamikanra","doi":"10.1177/1741134320962843","DOIUrl":"https://doi.org/10.1177/1741134320962843","url":null,"abstract":"Background Although generic medicines are used extensively in Nigeria information from community pharmacists about these drugs are scanty and therefore inadequate. This is why this study has been designed to bridge the knowledge gap, attitudes, as well as the perception and practice of community pharmacists about generic medicines in Nigeria. Method A questionnaire-guided cross-sectional survey was used to collect data from 380 community pharmacists who were randomly selected from community pharmacies between April and June 2019 in Southwestern Nigeria. Data generated in the course of this study was analysed with the Statistical Package for Social Sciences version 18. Descriptive statistics were used to summarize data. Chi-square was used to test proportions and to determine associations between categorical variables. Pearson’s Correlation Coefficient was used to determine correlation between dependent variables. Result Mean knowledge score of community pharmacists about generic medicines(GM) was 5.6 ± 2.9 out of a total maximum score of 10. Results showed that 47.9% of respondents had poor knowledge, 27.6% average knowledge and 24.5% good knowledge about GM. Knowledge was significantly associated (p = .000) with all demographic characteristics except professional qualifications. A majority (89%) of the respondents were of the view that patients need more explanations when GMs are dispensed to them. In addition, 90.3% of the respondents were of the opinion that GM will improve access to medicine because they are cheaper and easily affordable. About 93% practice generic substitution without consulting prescribing physicians. Furthermore, 85% of the respondents claim they stock mainly GMs. Conclusion Community pharmacists in Nigeria had a positive attitude, perception and practice about GM, but exhibited sub-optimal knowledge in understanding issues concerning generic medicines. It is concluded that there is the need for continuous training and education to enhance professional knowledge of pharmacists in the area of GM substitution.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"14 1","pages":"84 - 96"},"PeriodicalIF":0.0,"publicationDate":"2020-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80096554","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 : 2020-10-07DOI: 10.1177/1741134320963146
M. Z. Abbas
The current COVID-19 pandemic has put the problem of equitable access to health technologies in the limelight because governments, even in the economically advanced countries, are struggling to meet the health needs of their populations. Tiered pricing of innovative health technologies, which involves the division of markets into different tiers or groups, provides a legitimate policy tool to alleviate some of the COVID-19 financial burdens on global health systems. Differential pricing denotes the practice of companies to charge different prices for the same product depending on the different classes of purchasers. This paper examines the legality and practical significance of tiered pricing as a price-reducing policy option and discusses some of the key limitations of this important policy tool. This study proposes the adoption of a global framework for sustainable pricing and tiered pricing of innovative health technologies. The proposed global framework will help in achieving a balance between fair access and fair profit levels.
{"title":"COVID-19 and the global public health: Tiered pricing of pharmaceutical drugs as a price-reducing policy tool","authors":"M. Z. Abbas","doi":"10.1177/1741134320963146","DOIUrl":"https://doi.org/10.1177/1741134320963146","url":null,"abstract":"The current COVID-19 pandemic has put the problem of equitable access to health technologies in the limelight because governments, even in the economically advanced countries, are struggling to meet the health needs of their populations. Tiered pricing of innovative health technologies, which involves the division of markets into different tiers or groups, provides a legitimate policy tool to alleviate some of the COVID-19 financial burdens on global health systems. Differential pricing denotes the practice of companies to charge different prices for the same product depending on the different classes of purchasers. This paper examines the legality and practical significance of tiered pricing as a price-reducing policy option and discusses some of the key limitations of this important policy tool. This study proposes the adoption of a global framework for sustainable pricing and tiered pricing of innovative health technologies. The proposed global framework will help in achieving a balance between fair access and fair profit levels.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"16 1","pages":"115 - 121"},"PeriodicalIF":0.0,"publicationDate":"2020-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88966026","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 : 2020-09-03DOI: 10.1177/1741134320953875
Isabel M. Correia, Luís Armada, Paula Veiga
A large number of studies have focussed on the determinants of the entry of generics in the pharmaceuticals market. Most of them focus on the United States market. Much less evidence is found about heavily regulated pharmaceutical markets, such as the Portuguese market. This study uses data from Portugal, for the period 2000–2015. Based on a sample of 50 reimbursable outpatient drugs, that face potential entry of generics, two econometric models were estimated aiming to identify the determinants of entry and penetration of generics. The active substances included were chosen among those that represent the highest financial burden to the National Health System or are the most sold (in volume). To each of those active substances, the most sold pharmaceutical form, dosage, and package size was chosen. Our results suggest that market size is the main determinant of the generics entry. Concerning market penetration, our results show that it is determined by the number of marketed generics, as well as by price differences between brands and generics.
{"title":"Generics competition in the Portuguese pharmaceutical market","authors":"Isabel M. Correia, Luís Armada, Paula Veiga","doi":"10.1177/1741134320953875","DOIUrl":"https://doi.org/10.1177/1741134320953875","url":null,"abstract":"A large number of studies have focussed on the determinants of the entry of generics in the pharmaceuticals market. Most of them focus on the United States market. Much less evidence is found about heavily regulated pharmaceutical markets, such as the Portuguese market. This study uses data from Portugal, for the period 2000–2015. Based on a sample of 50 reimbursable outpatient drugs, that face potential entry of generics, two econometric models were estimated aiming to identify the determinants of entry and penetration of generics. The active substances included were chosen among those that represent the highest financial burden to the National Health System or are the most sold (in volume). To each of those active substances, the most sold pharmaceutical form, dosage, and package size was chosen. Our results suggest that market size is the main determinant of the generics entry. Concerning market penetration, our results show that it is determined by the number of marketed generics, as well as by price differences between brands and generics.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"86 1","pages":"17 - 28"},"PeriodicalIF":0.0,"publicationDate":"2020-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83929075","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 : 2020-08-30DOI: 10.1177/1741134320954256
Swagatika Tripathy, P. Murthy, BP Patra, P. Mehra, H. Dureja
Background China’s pharmaceutical market is growing at a healthy pace. This is due to potential rising per capita income, an increasing elderly population, urbanisation demographics and more access to health care. Methodology The methodology used is a comparative study on the basis of original empirical research. More specifically, the part of examination facts and regulation has been written by conducting empirical research on current international and national resource concerning the subject from books, various guidelines, rules and regulation, articles, published reports and internet. Results Generally the regulatory environment in China has been considered as an very challenging one. From regulatory perspective, CFDA regulations have not been stringent enough nor has it been robust enough to create a quality supply of medications, with (1) concerns in the subject matter, quality comparison between international regulatory standard and usually accepted local products and manufactures set standards; (2) a timeline for regulatory assessment and authorization of new drugs which is much longer in comparison to most countries; (3) less number of regulatory reviewer which has led to a backlog of earlier application. The journey to reshape China from ‘made-in-China’ to ‘discovered-in-China’ is highly challenging. (4) Complications with local protection, corruption and a lack of transparency. The directives from Government has recognized the need for significant system-level transformations for streamlining the pharmaceutical regulatory environment. Conclusion Continuing on the route of reform is promising that all Chinese citizens is eventually having access to safe, effective and high-quality medications in affordable price. These reformations are encouraging and promising not only for China’s health care system, but also for global Pharmaceutical industry and that’s the reason, now many big Pharma companies are considering China as a prime focus. The companies need to make use of the new opportunities, accessible to experience the benefit of faster time-to-market, and cause rewarding growth prospect for both domestic/ multinational companies.
{"title":"Challenges and prospects in Chinese pharmaceutical regulatory environment","authors":"Swagatika Tripathy, P. Murthy, BP Patra, P. Mehra, H. Dureja","doi":"10.1177/1741134320954256","DOIUrl":"https://doi.org/10.1177/1741134320954256","url":null,"abstract":"Background China’s pharmaceutical market is growing at a healthy pace. This is due to potential rising per capita income, an increasing elderly population, urbanisation demographics and more access to health care. Methodology The methodology used is a comparative study on the basis of original empirical research. More specifically, the part of examination facts and regulation has been written by conducting empirical research on current international and national resource concerning the subject from books, various guidelines, rules and regulation, articles, published reports and internet. Results Generally the regulatory environment in China has been considered as an very challenging one. From regulatory perspective, CFDA regulations have not been stringent enough nor has it been robust enough to create a quality supply of medications, with (1) concerns in the subject matter, quality comparison between international regulatory standard and usually accepted local products and manufactures set standards; (2) a timeline for regulatory assessment and authorization of new drugs which is much longer in comparison to most countries; (3) less number of regulatory reviewer which has led to a backlog of earlier application. The journey to reshape China from ‘made-in-China’ to ‘discovered-in-China’ is highly challenging. (4) Complications with local protection, corruption and a lack of transparency. The directives from Government has recognized the need for significant system-level transformations for streamlining the pharmaceutical regulatory environment. Conclusion Continuing on the route of reform is promising that all Chinese citizens is eventually having access to safe, effective and high-quality medications in affordable price. These reformations are encouraging and promising not only for China’s health care system, but also for global Pharmaceutical industry and that’s the reason, now many big Pharma companies are considering China as a prime focus. The companies need to make use of the new opportunities, accessible to experience the benefit of faster time-to-market, and cause rewarding growth prospect for both domestic/ multinational companies.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"92 1","pages":"106 - 114"},"PeriodicalIF":0.0,"publicationDate":"2020-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81676691","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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