Skickas inom vardagar. A very high portion of the seafood we eat comes from abroad, mainly from China and Southeast Asia, and most of the active ingredients in medicines we take originate in other countries. Many low- and middle-income countries have lower labor costs and fewer and less stringent environmental regulations than the United States, making them attractive places to produce food and chemical ingredients for export.
Food and Drug Administration FDA border inspections to be sufficient to ensure product purity and safety, and incidents such as American deaths due to adulterated heparin imported from China propelled the problem into public awareness. The Institute of Medicine Committee on Strengthening Core Elements of Regulatory Systems in Developing Countries took up the vital task of helping the FDA to cope with the reality that so much of the food, drugs, biologics, and medical products consumed in the United States originate in countries with less-robust regulatory systems.
Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad describes the ways the United States can help strengthen regulatory systems in low and middle income countries and promote cross-border partnerships - including government, industry, and academia - to foster regulatory science and build a core of regulatory professionals.
This report also emphasizes an array of practical approaches to ensure sound regulatory practices in today's interconnected world. This attitude could lead to poor adherence and antimicrobial resistance, to reduced demand for treatments, and to inappropriate switching to more toxic or ineffective therapies . More alarming is the fact that these cases are only the tip of the iceberg. Without adequate surveillance, most death and disease resulting from unsafe medicine is not detected.
Another example of why strengthening regulatory systems in low- and middle-income countries is important to global health is in the area of regulatory science, which is the development of public sector tools, methods, and models to accelerate and improve the regulation of innovative and generic products.
Strengthening Medicines Regulatory Systems Abroad
With the goal of increasing access to medicines, FDA scientists invented a method for conjugating meningitis vaccine that could easily be adopted by a low- or middle-income country production facility. They signed a technology transfer agreement with the Gates Foundation, WHO, and the Program for Appropriate Technology in Health, and trained scientists from industry and government in the conjugation methodology.
FDA scientists continued to share their technical expertise as the vaccine went through clinical trials, and in December of , the Drugs Controller General of India licensed the new vaccine, called MenAfriVac. To date, 20 million people have been vaccinated . If regulatory science can be strengthened in low- and middle-income countries, many more successes like MenAfriVac will be possible.
The global health community is gradually awakening to the role that regulatory systems play in low- and middle-income countries, as evidenced by the case studies in this paper, but more needs to be done to make strengthening these systems a global health priority. Efforts must be targeted and prioritized, with an end goal of sustainability in mind. It is not necessary for every low- and middle-income country system to be equivalent to that of a stringent authority like Canada or the European Union. Rather, there are several foundational elements that all regulatory systems, rich or poor, should have.
The US Institute of Medicine IOM identified three minimal capabilities: 1 a rule-making process that allows all stakeholders to comment on proposed regulations; 2 a protocol for different regulatory agencies to share information and oversight along supply chains; and 3 a method to identify when regulatory actions are necessary . Much more thinking needs to occur on what the IOM's suggested core capacities mean and how they might be implemented.
To this end, it will be important to begin a global dialogue on the subject of regulatory system strengthening in low- and middle-income countries. Various initiatives need to be coordinated and leveraged, including those already underway, such as the African Medicines Regulatory Harmonization initiative  , which seeks to speed medical product registrations, the Pan American Health Organization's Regional Platform on Access and Innovation for Health Technologies  , and the call for a single African medicines regulatory agency by stakeholders such as the African Union and United Nations AIDS  , .
Quality and Safety
Also, as other global health initiatives, such as the GAVI Alliance, the Global Fund, and the United States Global Health Initiative, turn their efforts towards health system strengthening  , it is critical that regulatory system strengthening be included as well. Garnering support for this agenda is not without its challenges. There are numerous competing priorities for political and financial support, especially in the wake of the global financial crisis.
Further, it is unlikely that global health will enjoy the same level of resourcing as in the previous decade .
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In the face of these challenges, it will be important to continue to communicate the value of regulatory systems to global health; to target their strengthening for sustainability; and to coordinate and leverage existing and planned capacity building initiatives. A global dialogue is beginning. Discussions of expanded market access for exports, increased trade opportunities emanating from science-based regulation and regulatory coherence, and more sustainable economic development, should also be included, as they will provide further incentives for countries to come to the table.
In summary, the case studies exploring global product supply chains and diethylene glycol poisoning in Panama, clinical trials regulation through AVAREF, premarket assurance through PEPFAR tentative approval, post-market surveillance in sub-Saharan Africa through research on drug and vaccine safety systems, and regulatory science through the creation of a low-cost meningitis vaccine for low- and middle-income countries, demonstrate the essential value of regulatory systems to low- and middle-income countries.
When they work, people live; when they fail, people die. As the challenges of globalization mount, and efforts to provide medical products to low- and middle-income countries scale up, there is no better time to put regulatory system strengthening squarely on the global health and development agenda.
Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad
Wrote the first draft of the manuscript: CP. Provenance: Not commissioned; externally peer reviewed. Summary Points Few global initiatives focus on strengthening low- and middle-income country medical product regulatory systems. However, globalization and the scaling up of medicines and vaccines to the developing world are highlighting the urgent need for systems to assure product efficacy, safety, and quality.
This article explores case studies in regulatory domains such as global product supply chains, clinical trials, premarket approval, post-market surveillance, and regulatory science to demonstrate the essential value of medical product regulatory systems to low- and middle-income countries. Here, a viable path is put forward for making this important topic a global health priority. Introduction Medical product regulatory systems are central to health systems; they ensure high quality and safe interventions like drugs, vaccines, and medical devices for patients who need and count on them.
Proposal We propose that strengthening regulatory systems in low- and middle-income countries must become a global health priority, and explain the imperative in terms of globalization and the rapid scale up of medicines to the developing world. Case Studies One reason low- and middle-income country regulatory systems have not traditionally received development assistance is that these systems did not manufacture products for high-income country markets.
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Challenges to Implementation The global health community is gradually awakening to the role that regulatory systems play in low- and middle-income countries, as evidenced by the case studies in this paper, but more needs to be done to make strengthening these systems a global health priority. Summary In summary, the case studies exploring global product supply chains and diethylene glycol poisoning in Panama, clinical trials regulation through AVAREF, premarket assurance through PEPFAR tentative approval, post-market surveillance in sub-Saharan Africa through research on drug and vaccine safety systems, and regulatory science through the creation of a low-cost meningitis vaccine for low- and middle-income countries, demonstrate the essential value of regulatory systems to low- and middle-income countries.
Author Contributions Wrote the first draft of the manuscript: CP. References 1. Accessed 30 August New York Times. Bogdanich W 14 February Panama releases report on '06 poisoning.
Varawalla N India's growing clinical research sector: opportunity for global companies. IDrugs — View Article Google Scholar Kuehn BM As production goes global, drug supply faces greater risks to safety, quality.
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