S. D. Gwatidzo, Petronella K. Murambinda, Zivanai Makoni
With the sprouting of unregulated outlets on the streets of Zimbabwe, common questions that are raised include: (i) what is the Medicines Control Authority of Zimbabwe (MCAZ) doing about these street vendors? and (ii) is the law against unregulated markets and proliferation of substandard and falsified (SF) medicines being actively enforced? There is no doubt that this is a new challenge for MCAZ because of the risks involved with SF medicines. Notwithstanding the rather strong regulatory framework for the regulated market that the MCAZ has major control over, and its demonstrable regulatory prowess over the last 20 years as a National Medicines Regulatory Authority (NMRA), MCAZ is increasingly challenged to take a leading role in addressing this rising phenomenon. MCAZ has attempted to address the problem through collaboration with the Zimbabwe Republic Police (ZRP), public education and inspections by port officials at ports of entry. However, the problem still persists. A general lack of concrete qualitative and quantitative data on the commonly encountered SF medicinal products on the Zimbabwe market is another major issue. This is evidently a multi-layered problem and as the Shona adage goes “chara chimwe hachitswanye inda” (loosely translated “one thumb cannot crush all lice”), there is need for engaging local and regional partners in a bid to fulfil the MCAZ's mandate of protecting public health by ensuring medicines and medical devices intended for sale and distribution in Zimbabwe, are safe, effective and of good quality.
{"title":"Medicines Counterfeiting in Africa: A View from Zimbabwe","authors":"S. D. Gwatidzo, Petronella K. Murambinda, Zivanai Makoni","doi":"10.5301/maapoc.0000017","DOIUrl":"https://doi.org/10.5301/maapoc.0000017","url":null,"abstract":"With the sprouting of unregulated outlets on the streets of Zimbabwe, common questions that are raised include: (i) what is the Medicines Control Authority of Zimbabwe (MCAZ) doing about these street vendors? and (ii) is the law against unregulated markets and proliferation of substandard and falsified (SF) medicines being actively enforced? There is no doubt that this is a new challenge for MCAZ because of the risks involved with SF medicines. Notwithstanding the rather strong regulatory framework for the regulated market that the MCAZ has major control over, and its demonstrable regulatory prowess over the last 20 years as a National Medicines Regulatory Authority (NMRA), MCAZ is increasingly challenged to take a leading role in addressing this rising phenomenon. MCAZ has attempted to address the problem through collaboration with the Zimbabwe Republic Police (ZRP), public education and inspections by port officials at ports of entry. However, the problem still persists. A general lack of concrete qualitative and quantitative data on the commonly encountered SF medicinal products on the Zimbabwe market is another major issue. This is evidently a multi-layered problem and as the Shona adage goes “chara chimwe hachitswanye inda” (loosely translated “one thumb cannot crush all lice”), there is need for engaging local and regional partners in a bid to fulfil the MCAZ's mandate of protecting public health by ensuring medicines and medical devices intended for sale and distribution in Zimbabwe, are safe, effective and of good quality.","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2017-05-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.5301/maapoc.0000017","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47575701","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}
M. Cinefra, C. Cagnazzo, L. McMahon, F. Arizio, S. Campora, R. Camisa, G. Canzanella, M. Contu, P. Frati, R. Sottile, S. Gori, G. Procopio, O. Nanni
Introduction Access to innovative medicine requires proper evidence from clinical trials with the growing demand of qualified and experienced personnel. The clinical research coordinator (CRC) plays an important role in the conduction of research activities and provides a strong support to the research team. In Italy, this role is not recognized at any institutional level and its professional outline is still indefinite. Several national associations (Associazione Italiana di Oncologia Medica, Collegio Italiano dei Primari Oncologi Medici Ospedalieri, Gruppo Italiano Data Manager) are committed to promoting the enhancement and recognition of the professional status of CRCs, underlining their role as fundamental. Methods A web survey, proposed by the AIOM CRC Working Group, was submitted to 319 Italian oncology sites with items focusing on the organization of sites, the research activities, the staff composition, and the presence of coordinators and the multidisciplinary team. Results A total of 115 sites (35.9%) responded to the web survey. Clinical studies were carried out at 88.7% of the investigated sites, and coordinators were on staff at 75.5% of the active investigational sites. Interestingly, there was a direct association between the number of clinical studies and the number of coordinators, whose contribution to the research activities is believed to be essential for trial conduct in 82.4% of cases. Most sites retain that the quality of clinical research has absolutely improved (83.3%) after the implementation of a coordinator as member of the team. Conclusions Given the constant growth of the number of clinical trials performed at Italian oncology sites, the CRC proves to be an essential component of the research team. However, there is an urgent need to institute the professional role alongside the need to standardize the training of coordinators to establish the minimum requirements enhanced by qualifying courses.
获得创新药物需要来自临床试验的适当证据，对合格和有经验的人员的需求日益增长。临床研究协调员(CRC)在研究活动的开展中发挥着重要作用，为研究团队提供了强有力的支持。在意大利，这一作用没有得到任何机构级别的承认，其专业大纲仍然是不确定的。几个国家协会(Associazione Italiana di Oncologia Medica, Collegio Italiano dei Primari Oncologi Medici Ospedalieri, Gruppo Italiano Data Manager)致力于促进crc专业地位的提升和认可，强调其作为基础的作用。方法采用AIOM CRC工作组提出的网络调查方法，对意大利319家肿瘤中心进行调查，调查内容包括中心组织、研究活动、工作人员构成、协调员和多学科团队的存在情况。结果共有115家网站(35.9%)参与了网络调查。88.7%的调查地点开展了临床研究，75.5%的活跃研究地点有协调员。有趣的是，临床研究的数量与协调员的数量之间存在直接关联，在82.4%的病例中，协调员对研究活动的贡献被认为对试验进行至关重要。大多数网站认为，实施协调员作为团队成员后，临床研究质量绝对提高(83.3%)。鉴于在意大利肿瘤中心进行的临床试验数量不断增长，CRC被证明是研究团队的重要组成部分。但是，迫切需要确立专业人员的作用，同时也需要使协调员的培训标准化，以确定通过合格课程加强的最低要求。
{"title":"The Critical Role of the Clinical Research Coordinator for Clinical Trials: A Survey in Oncology","authors":"M. Cinefra, C. Cagnazzo, L. McMahon, F. Arizio, S. Campora, R. Camisa, G. Canzanella, M. Contu, P. Frati, R. Sottile, S. Gori, G. Procopio, O. Nanni","doi":"10.5301/MAAPOC.0000015","DOIUrl":"https://doi.org/10.5301/MAAPOC.0000015","url":null,"abstract":"Introduction Access to innovative medicine requires proper evidence from clinical trials with the growing demand of qualified and experienced personnel. The clinical research coordinator (CRC) plays an important role in the conduction of research activities and provides a strong support to the research team. In Italy, this role is not recognized at any institutional level and its professional outline is still indefinite. Several national associations (Associazione Italiana di Oncologia Medica, Collegio Italiano dei Primari Oncologi Medici Ospedalieri, Gruppo Italiano Data Manager) are committed to promoting the enhancement and recognition of the professional status of CRCs, underlining their role as fundamental. Methods A web survey, proposed by the AIOM CRC Working Group, was submitted to 319 Italian oncology sites with items focusing on the organization of sites, the research activities, the staff composition, and the presence of coordinators and the multidisciplinary team. Results A total of 115 sites (35.9%) responded to the web survey. Clinical studies were carried out at 88.7% of the investigated sites, and coordinators were on staff at 75.5% of the active investigational sites. Interestingly, there was a direct association between the number of clinical studies and the number of coordinators, whose contribution to the research activities is believed to be essential for trial conduct in 82.4% of cases. Most sites retain that the quality of clinical research has absolutely improved (83.3%) after the implementation of a coordinator as member of the team. Conclusions Given the constant growth of the number of clinical trials performed at Italian oncology sites, the CRC proves to be an essential component of the research team. However, there is an urgent need to institute the professional role alongside the need to standardize the training of coordinators to establish the minimum requirements enhanced by qualifying courses.","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2017-05-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.5301/MAAPOC.0000015","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44648347","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}
There is a rising tide of criminal activity to manufacture and distribute falsified, counterfeit, or fake medicines. The exact size of this problem is unknown but estimates vary from US$75 billion to US$200 billion per year, and evidence clearly demonstrates it is on the increase. Depending on the world region, infiltration into the legitimate supply chain versus the illegitimate (e.g., the internet) varies greatly. However, what is certain is that the direction of travel by regulatory agents is to develop supply chains that allow access to medicines via the World Wide Web. Within this context, there has been a long-running debate about how to correctly describe the various forms of medicines that are fraudulently or otherwise manufactured and distributed. This article attempts to describe the evolution of the definitions and recommends that a consensus be formed to describe such medicines that reach the public: • Falsified medicine: This being the term used and defined in the Falsified Medicines Directive and which is primarily concerned with public health. • Counterfeit medicine: This is closely associated and legally defined within intellectual property legislation and concentrates on trademark protection. • Fake medicine: This is the term that best serves to communicate with the public to raise awareness about the phenomenon.
{"title":"What's in a Word? Falsified/Counterfeit/Fake Medicines - The Definitions Debate","authors":"M. Isles","doi":"10.5301/MAAPOC.0000008","DOIUrl":"https://doi.org/10.5301/MAAPOC.0000008","url":null,"abstract":"There is a rising tide of criminal activity to manufacture and distribute falsified, counterfeit, or fake medicines. The exact size of this problem is unknown but estimates vary from US$75 billion to US$200 billion per year, and evidence clearly demonstrates it is on the increase. Depending on the world region, infiltration into the legitimate supply chain versus the illegitimate (e.g., the internet) varies greatly. However, what is certain is that the direction of travel by regulatory agents is to develop supply chains that allow access to medicines via the World Wide Web. Within this context, there has been a long-running debate about how to correctly describe the various forms of medicines that are fraudulently or otherwise manufactured and distributed. This article attempts to describe the evolution of the definitions and recommends that a consensus be formed to describe such medicines that reach the public: • Falsified medicine: This being the term used and defined in the Falsified Medicines Directive and which is primarily concerned with public health. • Counterfeit medicine: This is closely associated and legally defined within intellectual property legislation and concentrates on trademark protection. • Fake medicine: This is the term that best serves to communicate with the public to raise awareness about the phenomenon.","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2017-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.5301/MAAPOC.0000008","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47553739","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 Early Access to Medicines Scheme (EAMS) was launched in the UK in April 2014 following a public consultation and government response, which outlined the scope of a potential scheme. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for two pivotal milestone decisions in the EAMS process: the Promising Innovative Medicine (PIM) designation and the EAMS scientific opinion, described in an EAMS public assessment report and 3 EAMS treatment protocols. In the 3 years since its launch, hundreds of patients with life-threatening or seriously debilitating conditions have benefited from EAMS medicines in a variety of mainly oncology indications. This editorial describes some of the achievements of the scheme over the past 3 years and provides insight into how the scheme may evolve over the coming years.
{"title":"Earlier Patient Access – the UK Early Access to Medicines Scheme (EAMS)","authors":"D. O’Connor, K. McDonald, S. Lam","doi":"10.5301/MAAPOC.0000009","DOIUrl":"https://doi.org/10.5301/MAAPOC.0000009","url":null,"abstract":"The Early Access to Medicines Scheme (EAMS) was launched in the UK in April 2014 following a public consultation and government response, which outlined the scope of a potential scheme. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for two pivotal milestone decisions in the EAMS process: the Promising Innovative Medicine (PIM) designation and the EAMS scientific opinion, described in an EAMS public assessment report and 3 EAMS treatment protocols. In the 3 years since its launch, hundreds of patients with life-threatening or seriously debilitating conditions have benefited from EAMS medicines in a variety of mainly oncology indications. This editorial describes some of the achievements of the scheme over the past 3 years and provides insight into how the scheme may evolve over the coming years.","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2017-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.5301/MAAPOC.0000009","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48504084","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}
M. Prada, M. Ruggeri, C. Sansone, Dalila De Fazio, A. Tettamanti, M. Mantovani
Introduction The main purpose of this analysis was to quantify the time elapsed between the validation date of European Medicines Agency (EMA) centralized procedure and the first purchase of a product by at least 1 Italian health care structure, evaluating different variables that affect the process, the number of products approved by the Committee for Medicinal Products for Human Use (CHMP) that are available on the Italian market (July 2016), and the impact of the Cnn class for oncology drugs in Italy. Methods A panel of oncology products has been defined, which considered drugs approved by the EMA between January 2013 and December 2015, and authorized for the treatment of oncology diseases, excluding generics. Data were obtained via the EMA website by the Agenzia Italiana del Farmaco (AIFA; the Italian Medicine Agency) meeting reports, by official administrative acts of marketing authorization, and the date of the first purchase (first day of the first handling month). Results The mean time of EMA evaluation for the considered panel of medicines was about 441 days (standard deviation (SD) 108; range 266-770); the average approval time for AIFA was about 248 days (SD 131; range 85-688). Interestingly, the mean AIFA evaluation time decreased significantly from 264 days for products submitted to AIFA assessment in 2013-2014 to 219 days for products evaluated in 2015-2016. Focusing on the regional access, both the timing and the number of drugs available for patients were widely different from region to region. Discussion A reduction in the approval time in the last 2 years has been observed in Italy. However, several variables influence the efficiency of the process and need to be addressed to make the access to drugs timely and efficient.
{"title":"Timeline of Authorization and Reimbursement for Oncology Drugs in Italy in the Last 3 Years","authors":"M. Prada, M. Ruggeri, C. Sansone, Dalila De Fazio, A. Tettamanti, M. Mantovani","doi":"10.5301/maapoc.0000007","DOIUrl":"https://doi.org/10.5301/maapoc.0000007","url":null,"abstract":"Introduction The main purpose of this analysis was to quantify the time elapsed between the validation date of European Medicines Agency (EMA) centralized procedure and the first purchase of a product by at least 1 Italian health care structure, evaluating different variables that affect the process, the number of products approved by the Committee for Medicinal Products for Human Use (CHMP) that are available on the Italian market (July 2016), and the impact of the Cnn class for oncology drugs in Italy. Methods A panel of oncology products has been defined, which considered drugs approved by the EMA between January 2013 and December 2015, and authorized for the treatment of oncology diseases, excluding generics. Data were obtained via the EMA website by the Agenzia Italiana del Farmaco (AIFA; the Italian Medicine Agency) meeting reports, by official administrative acts of marketing authorization, and the date of the first purchase (first day of the first handling month). Results The mean time of EMA evaluation for the considered panel of medicines was about 441 days (standard deviation (SD) 108; range 266-770); the average approval time for AIFA was about 248 days (SD 131; range 85-688). Interestingly, the mean AIFA evaluation time decreased significantly from 264 days for products submitted to AIFA assessment in 2013-2014 to 219 days for products evaluated in 2015-2016. Focusing on the regional access, both the timing and the number of drugs available for patients were widely different from region to region. Discussion A reduction in the approval time in the last 2 years has been observed in Italy. However, several variables influence the efficiency of the process and need to be addressed to make the access to drugs timely and efficient.","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2017-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.5301/maapoc.0000007","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"70607054","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 UK laws regarding the licensing of medicines have been developed to reduce the likelihood of harm through their use. Unlicensed medicines lie outside that harm management process; they have additional risks and require professional responsibilities that are complex. Therefore, pharmacy practice applies risk management tactics that are specific to how it manages unlicensed medicines, especially in hospitals, where the risks of their use is at its highest. Due to increasing demand and costs - but static funding - healthcare in the UK's National Health Service is under stress and undergoing a period of transformation and cost savings. That transformation affects all areas of pharmacy practice and medicines procurement. Service leaders need to keep a focus on maintaining safety systems for unlicensed medicines through a period of change, including potential changes in roles and responsibilities.
{"title":"Unlicensed Medicines in the UK - Legal Frameworks, Risks, and their Management","authors":"Ian M. Bourns","doi":"10.5301/maapoc.0000006","DOIUrl":"https://doi.org/10.5301/maapoc.0000006","url":null,"abstract":"The UK laws regarding the licensing of medicines have been developed to reduce the likelihood of harm through their use. Unlicensed medicines lie outside that harm management process; they have additional risks and require professional responsibilities that are complex. Therefore, pharmacy practice applies risk management tactics that are specific to how it manages unlicensed medicines, especially in hospitals, where the risks of their use is at its highest. Due to increasing demand and costs - but static funding - healthcare in the UK's National Health Service is under stress and undergoing a period of transformation and cost savings. That transformation affects all areas of pharmacy practice and medicines procurement. Service leaders need to keep a focus on maintaining safety systems for unlicensed medicines through a period of change, including potential changes in roles and responsibilities.","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2017-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.5301/maapoc.0000006","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46133413","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 industrialization of medicinal products has permitted us to reach important results in terms of quality, efficacy, safety, and availability of drugs; however, not all the legitimate expectations of patients are met. When an authorized medicinal product is not available on the market, the physician can prescribe other pharmacological treatments in the following scenario: off-label prescriptions, extemporaneous preparations, compassionate use of medicinal products, and medicinal products authorized in foreign countries. The best solution among these alternatives should be evaluated case-by-case on the basis of good scientific evidence, expert medical judgement, and published literature, also keeping an eye on the availability, the cost, and the regulatory requirements at a national level.
{"title":"Alternatives When an Authorized Medicinal Product is Not Available","authors":"F. Selmin, U. Musazzi, F. Cilurzo, P. Minghetti","doi":"10.5301/maapoc.0000005","DOIUrl":"https://doi.org/10.5301/maapoc.0000005","url":null,"abstract":"The industrialization of medicinal products has permitted us to reach important results in terms of quality, efficacy, safety, and availability of drugs; however, not all the legitimate expectations of patients are met. When an authorized medicinal product is not available on the market, the physician can prescribe other pharmacological treatments in the following scenario: off-label prescriptions, extemporaneous preparations, compassionate use of medicinal products, and medicinal products authorized in foreign countries. The best solution among these alternatives should be evaluated case-by-case on the basis of good scientific evidence, expert medical judgement, and published literature, also keeping an eye on the availability, the cost, and the regulatory requirements at a national level.","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2017-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43974932","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}
Brazil is a developing country of continental proportions and faces challenges in organizing an effective, universal, and affordable public health system. In a context of limited resources, the budget allocation to health care must be consistent with the health priorities of each population. The Brazilian population is ageing and the number of new cancer cases is likely to steadily increase in the near future. To deal with the extra cancer burden, strategies to match this future health necessity must be proactively put in place. Keeping the balance between the incorporation of a new drug and the sustainability of the public health system is a complex matter. Decisions for incorporation must be assessed, taking into consideration the ability of the drug to improve the public health in relation to its monetary impact. This is a societal discussion, and multiple stakeholders are involved in this process - from health authorities to pharmaceutical companies, researchers, and civil society. This article discusses the issues of incorporating a drug into the public health system and the strategies to improve access to innovative medicines, from the regulatory to the drug development perspectives.
{"title":"Access to Oncology Drugs in Brazil: Juggling Innovation and Sustainability in Developing Countries","authors":"F. Ades","doi":"10.5301/maapoc.0000004","DOIUrl":"https://doi.org/10.5301/maapoc.0000004","url":null,"abstract":"Brazil is a developing country of continental proportions and faces challenges in organizing an effective, universal, and affordable public health system. In a context of limited resources, the budget allocation to health care must be consistent with the health priorities of each population. The Brazilian population is ageing and the number of new cancer cases is likely to steadily increase in the near future. To deal with the extra cancer burden, strategies to match this future health necessity must be proactively put in place. Keeping the balance between the incorporation of a new drug and the sustainability of the public health system is a complex matter. Decisions for incorporation must be assessed, taking into consideration the ability of the drug to improve the public health in relation to its monetary impact. This is a societal discussion, and multiple stakeholders are involved in this process - from health authorities to pharmaceutical companies, researchers, and civil society. This article discusses the issues of incorporating a drug into the public health system and the strategies to improve access to innovative medicines, from the regulatory to the drug development perspectives.","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2017-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.5301/maapoc.0000004","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41481873","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}
Over the past 30 years, many national drug regulatory authorities have embarked on a process of gradual harmonization of all the technical aspects of studies, processes, and tests that generate the data necessary to support claims of quality, safety, and efficacy of medicines. This has been mainly a trade-driven process characterized by “region-specific” harmonization initiatives; the less-resourced authorities started this processes much later than the better-resourced ones. The immediate outcome of harmonized requirements is the eliminating of country-specific tests and studies, and the narrowing of gaps in the interpretation of data. This reduced the costs for pharmaceutical companies by enabling them to develop one single set of data and documentation to be submitted to several different countries. In addition, the harmonization processes are beneficial for public health: open-minded technical discussions and the exchange of ideas and experience among regulators of different countries contributes to strengthening the capacity of national authorities to expedite the assessment of priority medicines, and to filter out unsafe or substandard products.
{"title":"Medicines Regulatory Harmonization: International Collaboration as a Key to Improve Public Health","authors":"V. Reggi","doi":"10.5301/MAAPOC.0000001","DOIUrl":"https://doi.org/10.5301/MAAPOC.0000001","url":null,"abstract":"Over the past 30 years, many national drug regulatory authorities have embarked on a process of gradual harmonization of all the technical aspects of studies, processes, and tests that generate the data necessary to support claims of quality, safety, and efficacy of medicines. This has been mainly a trade-driven process characterized by “region-specific” harmonization initiatives; the less-resourced authorities started this processes much later than the better-resourced ones. The immediate outcome of harmonized requirements is the eliminating of country-specific tests and studies, and the narrowing of gaps in the interpretation of data. This reduced the costs for pharmaceutical companies by enabling them to develop one single set of data and documentation to be submitted to several different countries. In addition, the harmonization processes are beneficial for public health: open-minded technical discussions and the exchange of ideas and experience among regulators of different countries contributes to strengthening the capacity of national authorities to expedite the assessment of priority medicines, and to filter out unsafe or substandard products.","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.5301/MAAPOC.0000001","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"70607265","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}
{"title":"Facing Unmet Needs in Medicine Access at the Point of Care","authors":"G. Zuanetti","doi":"10.5301/maapoc.0000003","DOIUrl":"https://doi.org/10.5301/maapoc.0000003","url":null,"abstract":"","PeriodicalId":74158,"journal":{"name":"Medicine access @ point of care","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"70606975","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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