Pharmaceuticals, policy and law最新文献

{"title":"Registration dossier for radiopharmaceutical products","authors":"J. Mallol","doi":"10.3233/PPL-140408","DOIUrl":"https://doi.org/10.3233/PPL-140408","url":null,"abstract":"","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"87 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"126016392","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":"HTA's and access to rare diseases therapies: The view from the PID community","authors":"J. Prévot, D. Watters","doi":"10.3233/PPL-2011-0322","DOIUrl":"https://doi.org/10.3233/PPL-2011-0322","url":null,"abstract":"When managing their healthcare budgets, governments and national agencies responsible for the provision of healthcare are faced with a number of challenges. Assessing the clinical effectiveness of a medicinal product or device should be the main factor on which decisions to reimburse or not reimburse a specific health technology should be made. There are however many other factors that come into play. The rising costs of healthcare means that decision makers are increasingly implementing cost containment measuresto reduce expenditure. Lobbyingeffortsby stakeholders, the political environmentof a countryand the willingnessof healthcare managementbodiesto involvekeystakeholdersallareadditionalimportantconsiderationstotakeintoaccount in the outcomes of an assessment procedure.","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"118 1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"126419256","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":"Anginera™, three-dimensional fibroblast culture: Clinical path to treating cardiac ischemia","authors":"Michael Siani-Rose","doi":"10.3233/PPL-2010-0289","DOIUrl":"https://doi.org/10.3233/PPL-2010-0289","url":null,"abstract":"Anginera is an epicardial patch developed on the basis of Dermagraft, another FDA-approved product. The underlying principle is that the fibroblasts are cells which can attach and stretch across spaces thus creating a human tissue. Retained in a natural matrix, fibroblasts can deliver grow factors and cytokines [1] which can promote angiogenesis and blood vessel maturation (Fig. 1). Indeed, it has been observed that, following the positioning of the patch on the injured cardiac tissue, new cardiac vascularisation is formed, with improved perfusion and indications of improvement of ventricular wall motion.","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"179 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133633058","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":"EU marketing authorization subsequent to dissolution of the transferor and prior to effective transfer","authors":"Lucyne Ghazarian, C. Koenig","doi":"10.3233/PPL-130358","DOIUrl":"https://doi.org/10.3233/PPL-130358","url":null,"abstract":"Regulation (EC) No 2141/96 holds no explicit provision about the validity of a EU centralised marketing authorisation for a medicinal product during the time gap between dissolution of the transferor after granting of a favourable opinion by the EMA and effective authorisation by the European Commission. Marketing authorisations for medicinal products in terms of Article 3(1) of Regulation (EC) No 726/2004 are personal administrative acts, which, in principle, excludes a transfer unless otherwise and under exceptional terms allowed (enumeratio ergo limitatio). Regulation (EC) No 2141/96 constitutes such an exemption, laying down the procedural rules for a transfer of marketing authorisation. Though for this particular case the regulation holds no explicit provision about validity during the time gap. Despite the absence of a provision about validity the time gap has to be filled by teleological interpretation to ensure that amongst several possible interpretations the one will prevail which best guarantees the practical effect of existing Community law. The examination of the objectives of the Regulations (EC) No 726/2004 and No 2141/96 indicate the validity of the marketing authorisation and consequently the transferee’s authorisation during that period of time.","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"58 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128102384","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":"Priorities for the alpha-1 community: The physicians perspective","authors":"S. H. Chotirmall, T. Carroll, Muirne Spooner, N. McElvaney","doi":"10.3233/PPL-2009-0232","DOIUrl":"https://doi.org/10.3233/PPL-2009-0232","url":null,"abstract":"Alpha-1 antitrypsin (AAT) deficiency is a clinically under-recognized hereditary disorder with multi-system manifestations, most prominently in the lungs and liver. A rare skin manifestation is also described. The AAT protein is synthesized in the liver and to a lesser extent in macrophages and neutrophils. AAT is the physiological inhibitor of a variety of proteases most notably neutrophil elastase (NE). Unopposed, NE and other proteases attack the lung matrix causing structural damage and markedly impairing host defence. In the commonest form of AAT deficiency the mutated Z AAT is improperly folded, polymerises and aggregates in the liver. As a result less AAT is secreted into the bloodstream and gets to the lungs. This results in liver disease due to AAT aggregation in the liver and pulmonary damage due to the deficiency in the lung rendering it unable to protect against NE-mediated damage. In this review we will discuss AAT deficiency in detail, outlining the pathogenesis, and the clinical manifestations of the condition.","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"606 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132118039","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":"TEDDY EPMD: A European Paediatric Medicines Database","authors":"M. Felisi, R. Padula, F. Bartoloni, I. Grosch-Wörner, B. Kågedal, M. J. M. Peña, J. Parry, A. Stuchlík, K. Verhamme, A. Ceci","doi":"10.3233/PPL-2009-0211","DOIUrl":"https://doi.org/10.3233/PPL-2009-0211","url":null,"abstract":"In line with European initiatives, TEDDY set up a new database, the European Paediatric Medicines Database, with the aim of creating a harmonised, integrated and reliable pan-European source of information. The data stored in the Database were the basis for examining the ‘state of the art’ of paediatric medicines licensed by the European Medicines Agency between October 1995 and December 2007. The results of the study show that 33% of medicinal products approved by the European Medicines Agency are intended for the paediatric population, and that this percentage has remained more or less constant in the 12 years of activity of the Agency. This trend is expected to increase rapidly in the future as a result of the adoption of the Paediatric Regulation. Nevertheless, it is essential that information on medicinal products for paediatric use are made publicly accessible and data should be verified and controllable. The European Medicines Agency has recently made public many information on medicines authorised in EU through the EudraPharm database. The TEDDY European Paediatric Medicines Database grants access also to information related to paediatric medicines, some of which are not available elsewhere. We deem this aspect a useful service to end users and a valid support to Regulatory Authorities.","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"63 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121200106","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":"Balance between new treatment opportunities and public health expenditure control: The Regulatory Agency role","authors":"C. Tomino","doi":"10.3233/PPL-2010-0286","DOIUrl":"https://doi.org/10.3233/PPL-2010-0286","url":null,"abstract":"","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"126 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115199933","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":"Miracle products: Spanish pharmacy's great struggle to eradicate them","authors":"C. López","doi":"10.3233/PPL-2009-0223","DOIUrl":"https://doi.org/10.3233/PPL-2009-0223","url":null,"abstract":"The Spanish pharmacy model has two fundamental characteristics that may be summarised as the credibility of the community pharmacy as a healthcare establishment and the professionalism of the pharmacist as a healthcare agent. Currently, the professional activity of the pharmacist mainly revolves around the patient, with medicine being a healthcare tool he or she uses to practice his or her profession. However, the pharmacy as a healthcare establishment also covers other fields, such as the case of the Parapharmacy, which also require the pharmacist’s professional capacity, giving priority to the healthcare aspects over the financial ones. The Parapharmacy field includes health products where the professional action of the pharmacist forms an important added value that is recognised as such by society. As opposed to the Parapharmacy products correctly placed on the market, we find the so-called “Miracle Products”. Society is being invaded by products of differing natures and presentations,which try to find a place on the market by virtue of supposed healing or preventive properties for all types of complaints or health problems. Every year, in a seasonal basis, products are being detected (particularly foods or cosmetics) that promote the healing of incurable diseases or weight loss over a short period of time. Generally, the “miracle products” appear surrounded by short term, aggressive advertising campaigns and they disappear as soon as the health authorities act against them. Most of these fraudulent products do not include the clear identification of the company liable for them on the label, just a contact telephone number, web address or P.O. box number. The companies in charge of the marketing of this type of product are also aware of the healthcare value that the community pharmacies provide, and they try to use them for their own benefit. An example of this is that they frequently use, unilaterally, the advertising slogan of “on sale in pharmacies” or “ask your pharmacist for it”. They are also presented using devices, energies or apparatus that influence different parts of the human body alleging to produce effects that prevent, alleviate or cure diseases or complaints or soothe pain. In general, they are expensive and they manage to create expectations of success with their use that do not correspond to reality. Therefore:","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"31 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115236539","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":"The French compromise to achieve the rational use of medicines strategy","authors":"C. Baes","doi":"10.3233/PPL-2010-0300","DOIUrl":"https://doi.org/10.3233/PPL-2010-0300","url":null,"abstract":"The intention of this study lies in the analysis of the French efforts made so as to attain the strategy of the Rational Use of medecine. This concept has already been defended by the WHO, for many years. In a nutshell, this work consists on highlighting how the achievement of to Rational Use of the Medicament can be a solution for the populations to reach higher level of good health. So as to do so in France, a strategy has been set up, leading to the adoption of two important measures. The first one known as the \"Sanitary French Democracy, and the second one gets to modify the division of the territory allocated to each establisment.\" Finally, we will emphasize that the international help given in order to sustain the principle of development corresponds to a necessity of solidarity which is situated at the core of the French Republic. As a result, we need to highlight the essential role of non-governmental organizations (hereafter NGO) as well as the one of other French resources for development aid, such as strengthening the pharmacy policy in other countries.","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"43 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114876556","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":"Towards African Medicines Regulatory Harmonization: The case of the East African Community","authors":"J. Mwangi","doi":"10.3233/PPL-160435","DOIUrl":"https://doi.org/10.3233/PPL-160435","url":null,"abstract":"The role played by properly functioning regulatory systems towards enhancing access to essential medicines for patients is crucial. This is especially the case in Africa which has seen progressive growth in the regulatory environment. At the center of this growth has been the African Medicines Regulatory Harmonization (AMRH) initiative. This initiative seeks to strengthen regulatory capacity and encourage harmonization of regulatory requirements – with the ultimate aim of expanding access to quality, safe, and effective medicines for patients in need in Africa. A lot of progress has been made during the last years, with initial focus on the East African Community, where harmonization related regulations have already been implemented. The same is now being rolled out in other regions such as West Africa and the Southern African Development Community. Removing bottlenecks and reducing redundancies in regulatory processes that slow access to medicines for patients in need today is critical. In this sense, collaboration between the World Health Organization and relevant stakeholders, including the research-based pharmaceutical industry, on collaborative registration procedures that support fast and efficient review and approval of essential medicines in Africa is essential. African regulatory harmonization offers many benefits to regulatory authorities, patients in Africa and industry alike – and most critically for the protection of public health.","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"82 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127141677","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}