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The Global Health Technologies Coalition (GHTC) recently released the Global Health Regulatory Requirements Database. The database is a unique resource designed to help researchers and regulatory professionals access necessary information to develop effective strategies for gaining approval to conduct clinical trials and market products.The database includes high-level regulatory information on a variety of countries in Africa, Asia, and Latin America, as well as links to key guidance documents and other resources where users can find more detailed information. Information included in the database includes: contact information for national regulatory authority regulators; information on the country’s institutional review board structure; an overview of clinical trial and product registration data requirements, costs, and timelines; and post-registration pharmacovigilance requirements. The Global Health Regulatory Requirements Database offers users easy navigation from country to country, and separates technology specific information into three categories—drugs, vaccines, and diagnostics. Information will be reviewed and updated regularly to ensure its accuracy, as well as to expand the country and data information included. To access the database, please click here.

In this guest post, Angeline Nanni—director of Market Access at Aeras—reflects on World Immunization Week. Through the heroic efforts of infant and childhood global vaccination programs, childhood diseases that once caused millions of deaths across the globe have been thwarted. Hope has overshadowed fear as preventive vaccines help the healthy to remain free from deadly diseases and allow whole communities to thrive. In honor of World Immunization Week, we applaud those at national health departments, the Gavi, the Vaccine Alliance, United Nations Children’s Fund, the World Health Organization, and others whose dedication, expertise, and political will have led to ambitious and successful immunization campaigns. Remarkable results of global and national vaccination campaigns and programs have led to: Smallpox eradication. Polio endemic in only three countries as opposed to 125 countries 25 years ago. Measles deaths worldwide reduced by 78 percent between 2000 and 2007. Additionally, estimates show that an additional 1 million children’s lives will be saved every year with the accelerated introduction of vaccines against pneumococcal disease and rotavirus. The MenAfriVac® vaccine is expected to prevent 437,000 cases of meningitis over the next 10 years, saving 43,500 lives and approximately $570 million. Significant progress is being made in research and development efforts for new vaccines against TB. Credit: PATH/Evelyn Hockstein Immunization has saved the lives of more children than any other medical intervention in the last 50 years. However, one in five children still do not have access to these lifesaving vaccines. The majority of these children lives in the poorest countries and regions of the world, and faces the highest risk of exposure to life-threatening, vaccine-preventable diseases like measles and meningitis. We must make a concerted effort to ensure that vaccines are available and accessible to all who need them, as laid out in the Global Vaccine Action Plan. This Plan, which was endorsed by the World Health Assembly in 2012, provides a framework for achieving the vision of delivering universal access to immunizations for all people, at affordable and sustainable prices. While many generations in developed countries have benefited from vaccines, newer generations have never experienced the death and devastation caused by vaccine-preventable diseases. This has led to complacency, skepticism, and misinformation about the safety and value of vaccines. We cannot let this undo the tremendous gains that have been achieved through vaccines. We cannot go back to a world where children die, families are devastated, and communities are vulnerable to diseases that could be prevented by routine and safe vaccinations. The extraordinary success of vaccines in saving millions of lives and improving health throughout the world has the potential to protect millions more from other deadly infectious diseases, like tuberculosis (TB). The deadly combination of TB and HIV and increasing rates of drug-resistance are making this disease more difficult to diagnose and treat, and more deadly. There has been important progress in developing new drugs and diagnostics, but TB will remain a global threat without new, more effective vaccines. Prevention through vaccination would be the most cost-effective tool to mitigate these global epidemics. Recent economic and health impact modeling demonstrates that a 60 percent efficacious adolescent and adult preventive TB vaccine, delivered to a mere 20 percent of the population, could potentially avert as many as 40-60 million new cases of TB over the course of 26 years and would be cost-effective. A significantly improved infant vaccine could potentially avert 5-10 million cases of TB over that same time period. Significant progress is being made in research and development efforts for new vaccines against TB. To date, more than 16 TB vaccine candidates have been tested in human clinical trials, and scientists are doing basic research to discover effective correlates of protection for TB vaccines. As researchers continue developing TB vaccine candidates and moving them through preclinical and clinical studies, we are simultaneously working on early access strategies to maximize public health impact and be better prepared to accelerate vaccine delivery to reach those hardest hit by the TB epidemic. Vaccines have made the world a vastly different place by reducing the incidence of disease, providing freedom from worry and fear of the death and disability that they cause. Vaccines hold the key to a healthier and wealthier world for all of us. This week we recognize the success of critical vaccine implementation efforts. We support more scale-up of these implementation efforts, the goal of universal coverage, and the research and development of new vaccines to prevent even more disease and deaths. We look forward to the day when TB is also added to the list.

Earlier this month, Reps. Albio Sires (D-NJ) and Mario Diaz-Balart (R-FL) introduced the 21st Century Global Health Technology Act, which would make several important and welcome changes to global health research and development (R&D) programs at the US Agency for International Development (USAID). Previous versions of this legislation were introduced in 2009 and again in 2011, but did not advance past the committee level. Compared with the previous versions, the bill introduced this month includes several key changes that take a more comprehensive approach to global health R&D at USAID. Key provisions in the bill include: Codifying into law the Health Technologies (Health Tech) program at USAID, which would help ensure that this important program is sustainable. In its first 25 years of operation, the Health Tech program has produced 85 new global health technologies with more than 100 different partners, all aimed at addressing the needs of low-resource settings around the world. Requiring that the USAID administration develop an action plan on global health R&D. The bill would require that these action plans incorporate global health R&D into each of USAID’s global health programs, and would require the agency to develop metrics to measure success. Recognizing the importance of USAID’s Center for Accelerating Innovation and Impact (CAII). CAII conducts market analysis and product introduction studies across USAID’s global health product development portfolio, in an effort to improve and speed scale-up of important new tools. Requesting that USAID continue its annual reports on health-related R&D. These reports would include information on: health R&D progress within each of the agency’s global health programs; how USAID coordinates translational and applied research with other US agencies; and USAID’s investments in science, technology, and innovation—an area that USAID Administrator Rajiv Shah has stated is a priority for the agency. Requesting that USAID work to align its health-related research strategy with similar strategies at other agencies, with the intent of creating a whole-of government strategy for global health R&D. Earlier this month, Reps. Albio Sires (D-NJ) and Mario Diaz-Balart (R-FL) introduced the 21st Global Health Technology Act, which would make several important and welcome changes to global health R&D programs at USAID. This new legislation—which was developed in close partnership with GHTC member PATH—supports global health R&D efforts across USAID. While it includes the Health Tech program, it also promotes research programming for every disease or health condition category that falls under USAID’s global health mission. This is an important sign of progress, as there are many health areas where new drugs, vaccines, diagnostic tools, and other technologies are sorely needed. This includes R&D for neglected tropical diseases and tuberculosis vaccines, which currently do not receive support from USAID. The legislation also looks across USAID’s spectrum of R&D work and takes into account introduction and scale-up needs, as well as harnessing the promise of science and technology—which Shah and President Obama have previously highlighted. Finally, the addition of strategy alignment with other US agencies is another welcome change. Because the United States is involved in the development of 200 of the 365 current technology candidates in the global pipeline, a strategy that aligns all US global health R&D would increase transparency and coordination among the major agencies that support this important work. It is unclear at this point how the bill will move forward, although there are several mechanisms available. For example, the bill could progress in Congress as a stand-alone bill, or as an amendment to a larger foreign affairs or global health package. At this point, there is no Senate version of the bill, although that may be a positive next step. If implemented, this legislation could provide promising improvements in US global health R&D transparency, coordination, and financing that would help new global health technologies reach those who need them most. You can find a press release from Rep. Sires here.

In this guest post, Heather Ignatius, senior policy and advocacy officer at PATH, writes about the important role US agencies play in advancing global health technologies. In the field of global health, partnerships are often a primary key to success. The complexities of health, policy, and product development are technically nuanced, but together with the US government, PATH and others are making great advances to adapt, develop, and introduce breakthrough technologies across the health spectrum. To demonstrate how essential US government’s contributions have been—and will continue to be—in improving global health through the development and introduction of lifesaving technologies, we recently released three publications highlighting PATH’s work with the US Agency for International Development (USAID), the US Department of Defense (DoD), and the US Department of Health and Human Services (HHS). These collaborations complement the many other global health product development and introduction efforts spearheaded by other private- and public-sector partners. Together, these contributions to improving global health will not only benefit people in developing countries, but also US military personnel and US citizens traveling abroad. We hope that these examples inspire continued investment by the US government in global health research and development. PATH partners with the US government to develop and adapt innovative global health technologies—including thermostable vaccines, injection devices, and medicines—that safeguard the health of mothers and children, like these in Kenya. Credit: PATH/Evelyn Hockstein. Developing innovative technologies in partnership with USAID For more than 25 years, PATH has worked through the HealthTech program at USAID to identify health needs and then adapt, design, develop, and advance appropriate and affordable health technology solutions. Through the HealthTech program, PATH has invented, designed, developed, or co-developed 85 technologies that are tailored to low-resource settings and can be manufactured locally. Examples include diagnostic tests for infectious diseases, portable scales that help health workers screen newborns for low-birthweight status, the Uniject® injection system, and the SILCS diaphragm. HealthTech technologies are in use throughout the world through partnerships with the World Health Organization, the United Nations Children’s Fund, and commercial collaborators. Adapting and introducing diagnostic technologies for low-resource settings with HHS With funding from the National Institutes of Health, PATH is advancing effective, low-cost, and easy-to-use diagnostic tools that can be used in low-resource settings to identify HIV and AIDS, tuberculosis, malaria, and other diseases. These diagnostics improve people’s chances for a healthy recovery while enabling health care workers to better track outbreaks of diseases. Together, PATH and HHS have also worked to increase the availability, accessibility, and affordability of essential point-of-care diagnostic tests by assessing critical clinical needs, identifying innovative technologies, supporting clinical testing, and creating training programs. Developing new vaccine technologies with DoD In collaboration with the US Naval Medical Research Center (NMRC) and the Walter Reed Army Institute of Research (WRAIR), PATH is developing and testing new approaches for vaccines against enterotoxigenic Escherichia coli and Shigella—two of the leading bacterial causes of diarrheal disease worldwide. PATH, WRAIR, and NMRC are collaborating on preclinical and clinical studies as well as manufacturing activities related to vaccine development. Additionally, PATH is working with NMRC, among other partners, to assess potential markets for low-cost and effective vaccines and to demonstrate the opportunity for industry investment in developing these vaccines. With funding from the Defense Threat Reduction Agency, PATH is developing temperature-stable vaccine formulations to support DoD product development efforts. These thermostable formulations will extend the shelf life of vaccines, making them ideal for storing and allowing them to be safely transported and stored for extended periods of time outside of the “cold chain” of proper refrigeration. Thermostable vaccines are especially important for remote areas of the world where limited or no electricity for temperature control makes it challenging to maintain vaccines’ potency.