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[Editor's note 4/1/16:The Global Health Regulatory Requirements Database is no longer part of GHTC. The global health regulatory team's member site is now hosted on the Gates Foundation PDP forum.] Photo: FDA/Michael J. Ermarth Navigating global regulatory processes is a critical component to the development and introduction of global health technologies. New drugs, vaccines, medical devices, and diagnostics must be evaluated and registered by national regulatory authorities before they can reach patients who need them. These technologies are typically intended for use in low- and middle-income countries (LMICs) which often have limited regulatory capacity and evolving regulatory requirements. As a result, securing clinical trial and product registration approval from national regulatory authorities can be a considerable hurdle for product developers. The GHTC’s Global Health Regulatory Requirements Database, developed with support from the Bill & Melinda Gates Foundation, is a tool that helps product developers and global health advocates better understand and navigate regulatory requirements of LMICs. The database serves as a critical information tool to help facilitate the testing and launch of new, lifesaving global health technologies. Here are four reasons why you should check it out: 1. It’s easy to use. Organized by country and technology type, the database features high-level summaries of regulatory requirements for 25 countries in Africa, Asia, Europe, and Latin America. The database conveniently consolidates regulatory requirements for these countries in one place, so users don't have to spend as much time tracking down regulatory information for different countries. Think of it as Cliff Notes for global health regulatory processes. 2. It’s comprehensive, but still comprehensible. Users can access top-line information on regulatory authority structure, relevant harmonization initiatives, ethics review processes, clinical trial and product registration application requirements, and pharmacovigilance requirements. You can also find links to key guidances and other relevant resources. All the information is presented in an easy-to-scan format so you can find what you seek. 3. It’s regularly updated. In August 2014, the Global Health Technologies Coalition (GHTC) completed its annual verification of the database. All information in the database is systematically reviewed on an annual basis, and significant changes to country regulatory requirements also are added on an ad-hoc basis. 4. It’s constantly expanding. During the last year, the GHTC introduced eight new countries to the database—Bangladesh, Ghana, Malawi, Malaysia, Nepal, Peru, Russia, and Ukraine! The GHTC also recently added country-specific labeling requirements and expanded information on regulatory authority collaborations with the World Health Organization and stringent regulatory authorities like the US Food and Drug Administration and European Medicines Agency. Whether you are a global health product developer or an advocate, you’ll find the database to be a useful tool. It can help product developers access necessary information to formulate a regulatory strategy, and can help advocates identify areas to provide and champion technical assistance for capacity development, harmonization, and other ways to advance global regulatory processes.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. National Geographic takes an in-depth looks at how scientific hurdles, ethical concerns, and politics have slowed progress on the development of a vaccine against Ebola. The piece traces the development of the experimental vaccines and treatments currently being tested and examines how funding constraints and ethical decisions on how to allocate research funds relative to disease burden have impeded the development of an Ebola vaccine. Devex previews the conversation and debate that will soon unfold about how the world will successfully finance the Sustainable Development Goals. In July 2015, the international development community will gather in Addis Ababa, Ethiopia at the International Conference on Financing for Development to tackle this issue. With many traditional donor countries still struggling economically and failing to meet funding targets for development assistance, the article discusses the challenge of putting together a plan to finance what looks to be an ambitious set of developments goals. Malaria No More and the Bill & Melinda Gates Foundation explore the next generation of treatments that seek to eliminate the malaria parasite from the human body. While malaria research has traditionally focused on blocking transmission of the parasite by protecting people from mosquito bites, new research is exploring ways to interrupt the transmission of the parasite from man back to mosquito. In an interview on NBC’s Meet the Press, Dr. Anthony Fauci—head of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health—said he disagreed with Dr. Francis Collins statement last week that an Ebola vaccine would likely have already been discovered if it were not for federal budget cuts. While Dr. Fauci noted that budget cuts have slowed down research overall, he said he would not speculate about what medical developments were prevented as a result of these cuts.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The first vaccine against hookworm has been shown to be safe in clinical trials in Brazil, according to researchers from the Sabin Vaccine Institute Product Development Partnership who led the trial. The vaccine—which was developed by the HOOKVAC consortium—was well tolerated by 102 healthy volunteers, and blood tests indicated they developed an immune response. The Bill & Melinda Gates Foundation’s Grand Challenges in Global Health program celebrated its 10th anniversary recently. The Economist takes a look at the past ten years and discusses the program’s successes, disappointments, and what its future holds. In an interview with the Huffington Post, Dr. Francis Collins—director of the National Institutes of Health— said that a vaccine for Ebola would likely have been discovered were it not for budget cuts experienced by the agency. "Frankly, if we had not gone through our 10-year slide in research support, we probably would have had a vaccine in time for this that would've gone through clinical trials and would have been ready,” said Collins. The BMJ blog looked at the challenge countries face in accessing lifesaving drugs and vaccines as they shift from classification as low-income countries to middle-income countries (MICs). Due to tiered pricing structure and market segmentation plans implemented by pharmaceutical companies and aid organizations, as a country enters the MIC tier, it often is excluded from access to the lowest priced medicines and vaccines.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. GHTC member PATH—along with the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and the Serum Institute of India (SII)—will receive a national award for this year’s most outstanding intellectual property licensing deal for the group’s technology transfer of the MenAfriVac™ vaccine—a low-cost meningitis vaccine specifically developed for people in sub-Saharan Africa. The 2014 Deal of Distinction Award—which recognizes excellence in licensing deals—will be presented to the group by the Licensing Executives Society at its annual meeting in early October. In a recent FDA Voice blog post, Food and Drug Administration (FDA) Commissioner Margaret Hamburg writes about FDA’s new strategic priorities. Given that the FDA continues to expand its global reach, and that nearly 40 percent of medicines Americans consume are developed outside the United States, the agency has established five strategic priorities: regulatory science, globalization, safety and quality, smart regulation, and stewardship. Policy Cures writes in their monthly update, RADAR, about recent news on global health research and development in Australia. Australia has committed AUD$30 million in annual funding to health research for development—including $10 million for product development partnerships. Five million dollars of funding could also be used for a health innovation fund (possibly a Grand Challenges Australia). As the Ebola outbreak in West Africa continues, the Center for Global Development looks at ways to find a cure for this deadly disease. They argue that two things are needed: cost-effective thresholds for investments in global health, and an Advance Market Commitment to accelerate the development of new vaccines for Ebola and other neglected diseases.