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GHTC’s PQ Pulse interview series explores challenges in navigating the World Health Organization’s (WHO’s) prequalification (PQ) program with various stakeholders engaged in the regulatory ecosystem.  In our third installment, we spoke with Dr. Benjamin Djoudalbaye, head of the African Medicines Agency (AMA) interim secretariat, to discuss the agency's role in advancing regulatory harmonization across the continent and its intersection with WHO's PQ program.   In our interview, which has been lightly edited and condensed below, Dr. Djoudalbaye discusses his vision for a harmonious regulatory system across the African continent.   GHTC: To begin our conversation today, it would be helpful for you to outline AMA’s scope and highlight its current status.  Dr. Djoudalbaye: Yes, thank you for the question, and thank you for the opportunity for AMA to tell its story.  AMA is a specialized agency of the African Union, established to regulate and harmonize oversight of medicines, vaccines, medical devices, and veterinary and traditional medicines across the continent. The overarching goal of the agency is to ensure that all Africans have access to high-quality, safe, and effective medical technologies.   This is a quite broad definition of AMA, as it also has some specific key functions. These include regulatory harmonization across African regulatory bodies, assessing and listing medical products, pharmaceutical manufacturing, market surveillance, and supporting growth of local manufacturing in alignment with the African Pharmaceutical Manufacturing Plan. Oversight of clinical trials and good manufacturing practices also fall under the purview of the agency. I named just a few functions of AMA, but there are many more.In terms of governance, AMA is established by a treaty that is undergoing ratification and is currently endorsed by 31 countries. A Conference of State Parties has been established to oversee it, in addition to a governing board and secretariat. Dr. Delese Mimi Darko was appointed as AMA’s Director-General and will assume her role very soon at the agency’s headquarters in Kigali, Rwanda. My role consists of laying the foundation for Dr. Darko to take over and lead the institution. GHTC: That’s helpful context to gain an overview of AMA. It’s also exciting to see how much progress has been made to operationalize the agency in such a short among of time. GHTC: How do you see AMA’s role evolving as it relates to PQ, potentially as a partner and/or taking ownership of certain functionalities?Dr. Djoudalbaye: That’s an interesting question and one that I do not have all the answers to. AMA has not given an official position on its relationship with WHO PQ, but I can provide a few ideas on how that might play out.  To me, PQ has long served as a global benchmark for ensuring the quality, safety, and efficacy of medical products, particularly for [low- and middle-income countries] that lack robust regulatory systems. Africa has gotten support from this program’s rigorous assessment of medicines, diagnostics, and vaccines for products procured by [UNICEF] or by Gavi, the Vaccine Alliance, as those products must be prequalified by WHO before they are procured and then delivered. So that’s one way PQ and AMA will continue to engage with one another. We also need collaboration for quality control of health technologies, which is WHO PQ’s guaranteed service. Providing technical support and training to national regulatory authorities, specifically guidance for local manufacturers seeking to achieve international quality standards, is another area of expected engagement with WHO.  AMA is positioned to harmonize and coordinate Africa's network of quality control laboratories and build on platforms developed through PQ. So, in this regard, PQ is extremely important, and AMA needs to build on that. Despite the progress we see with AMA, we need to recognize the continent’s reliance on national and regional regulators. On the continent today, we have three layers. Layer one is the continental level, of what AMA will do and implement; the second is the African Medicine Regulatory Harmonization program, working alongside regional economic initiatives; and the third layer is the national level. It is important that these layers communicate with one another as they transition from reliance to recognition. Further down the line, we can think about leveraging the WHO Foundation to develop an Africa-specific or fast-tracking product assessment system that focuses on regional health priorities and locally manufactured products as a possible idea. Long-term, my goal is for AMA to decrease Africa’s dependence on external prequalification.GHTC: Yes, I agree. It’s hard in this environment to make any sort of clear determinations with all that is moving around us, especially with WHO’s reform, as well as changes in the US landscape.  GHTC: What challenges are you facing day-to-day? How do you ensure that you continue the forward momentum, as AMA is undergoing ratification?  Dr. Djoudalbaye: One challenge is the fragmented regulatory frameworks across the African continent, and it will be AMA’s role to coordinate and bring those stakeholders together. The diverse—and sometimes conflicting—regulations across countries and regions make it difficult for manufacturers to comply effectively, especially for those working across jurisdictions. We have countries with different national languages, which can also make alignment difficult. One united framework will help address bottlenecks, reduce approval times, reduce markets to entry, and bring down administrative costs.  Another challenge is bureaucratic inefficiencies. Complex, opaque regulatory procedures increase operational costs, discourage investments, and create barriers to scaling innovation. The issue may be—and I am choosing my words carefully here—perceived corruption and inconsistent regulatory enforcement in some countries that can erode trust in the system.Inadequate regulatory oversight is another pain point. Many regulatory authorities lack resources and capacity, and that is a contributing reason to why we only have eight African countries that have achieved maturity level three [Editor note: WHO has a four-level system for assessing the strength and functionality of national regulatory authorities]. We are striving to have at least half of Africa’s member states reach maturity level three, others to reach four, and even potentially have regional bodies added as WHO-listed authorities [Editor note: WHO-listed authority is a designation for countries with stable, well-functioning regulatory systems]. Policy integration and public-private collaboration are other areas to improve. In terms of integrated policy development, we need to encourage cross-sectional policymaking alignments, bringing the industrial, science, and trade sectors closer to create a coherent investment in the regulatory environment. Engaging private-sector voices in shaping regulatory reforms is important to innovating technology, developing skills, and modernizing regulatory technologies. For instance, we can fast-track product entry into the market by leveraging blockchain technology in regulatory affairs to expand training, technical education, and international partnerships like WHO PQ. Inconsistent adoption of international standards is another issue. There are disparities between local regulators and international standards that complicate compliance and block access to global markets, especially in high-growth sectors, such as pharmaceuticals and food processing.  Finally, trade barriers have emerged as another bottleneck. Persistent non-tariff barriers and the slow implementation of agreements like the African Continental Free Trade Area restrict intra-African trade and regulatory harmonization efforts.  So how do we overcome these challenges? We need regulatory reforms and harmonization to streamline bureaucratic processes from regional regulators to continental ones, like AMA. This will make it easier for businesses to expand across borders and tap into larger markets.  GHTC: This is a great transition to our last question: what do you envision for AMA as an agency for the next five to ten years?  Dr. Djoudalbaye: In the next five to ten years, I want to see AMA poised to become a cornerstone of Africa’s health regulatory landscape and shape the continent’s access to safe, effective, and high-quality medical products. We must also eliminate substandard and falsified products, and I see that as an avenue for a quick win for the agency. Overall, AMA’s emergence will signify a unified and collaborative regulatory framework that is vital for the continent.  Decentralization and harmonization are important to continental regulatory leadership. This will also strengthen national agencies, so we need to build capacity at the continental, regional, and country levels. However, AMA cannot solve everything. Integration of these levels will be essential for the scientific capabilities of the agency. I want to see AMA as a high-quality and independent organization, so its regulatory decisions are evidence-based and preserve scientific integrity.  GHTC: Thank you for your time, your insights, and your proposed solutions. 

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. Last week, the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) announced that it is awarding $3 million to Baxiva to support the development of a vaccine that targets the most common serotypes associated with invasive Escherichia coli infections. E. coli is the leading cause of urinary tract infections around the world and a common cause of neonatal sepsis infections, particularly in low- and middle-income countries. The candidate uses new targets that haven’t been used in other vaccines and targets several bacterial strains. The company’s rapid development platform also enables it to quickly design vaccines targeting various types of bacteria.The Coalition for Epidemic Preparedness (CEPI) last week announced a global collaborative effort to carry out epidemiological and computational modelling projects to help strengthen scientific understanding of the Rift Valley fever and its impact across Africa, helping guide the planning of future clinical trials assessing much-needed vaccine candidates for the disease. Despite major Rift Valley fever outbreaks seen in Africa and beyond and global recognition of the need to boost R&D efforts, there are large gaps in our knowledge about the burden and spread of the disease. The two projects, led by institutions in Kenya and Tanzania and supported by global partners, will assess the impact of the disease across Africa, as well as forecast its future burden, providing crucial data for vaccine developers to plan large-scale trials when the virus is widely circulating.A new study from the University of Alabama at Birmingham demonstrates that an antibody designed to target the dengue virus could also block the spread of the Zika virus, an important finding that could inform the development of much-needed treatments for Zika. There are no approved treatments for Zika, a dangerous virus that can pose severe risks to pregnant people and their babies. In a novel preclinical in vivo model, the antibody helped stop the virus from spreading, particularly in vulnerable parts of the body, leading to improved survival rates.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. A research team at the Massachusetts Institute of Technology used artificial intelligence (AI) to design two new potential antibiotics to target drug-resistant gonorrhea and MRSA, which were successful in laboratory and animal tests. Rising antimicrobial resistance has underscored the urgent need for new antibiotics to treat drug-resistant infections, and scientists have been researching how AI could play a role in streamlining the tricky, time-consuming, and expensive task of searching through thousands of known chemicals to identify ones with potential to become new antibiotics. These researchers also brought the technology into the next step of drug development, using generative AI to actually design antibiotic compounds for further study by feeding the AI model data about the chemical structure of known compounds and whether they slow the growth of different bacterial species. While the antibiotic compounds will still need to undergo years of further study and clinical trials, they could serve, if proven effective, as important new tools against the rise of antimicrobial resistance, and, more broadly, this research could pave the way for AI to revolutionize antibiotic discovery, just as this growing threat heightens the need for new drugs.Newly published results from a study done by PATH and PT Bio Farma show that the novel live attenuated type 1 and 3 oral polio vaccines are similarly safe and effective compared to the monovalent Sabin-strain oral polio vaccines. The novel types 1 and 3 oral polio vaccines were developed in response to the rare but concerning risk of vaccine-derived polio associated with the Sabin-strain oral polio vaccines, and these results support the progression of these vaccine candidates to Phase 2 studies. If they continue to prove effective, new oral polio vaccines could support global efforts to boost immunization while reducing the risk of vaccine-associated polio. The study was conducted at four US centers among 205 adults with varying polio vaccination histories.A research team at Arizona State University has developed a test for multiple infectious diseases that is affordable, quick, and non-invasive, offering a new tool for improving access to rapid diagnosis and connection to treatment in low-resource settings around the world. The NasRED (Nanoparticle-Supported Rapid Electronic Detection) test uses just a single drop of blood, costs mere dollars, delivers results in only 15 minutes, and is simple and portable enough to be used in a wide variety of health care settings, including those without significant laboratory infrastructure or health care workers with specialized laboratory training—without sacrificing accuracy. Its developers say it could be a game-changer in an infectious disease outbreak scenario, as well as for diseases that are difficult and important to detect early, including hepatitis C or HIV. Specifically, the test uses tiny gold nanoparticles that are coated with special molecules designed to detect even extremely small amounts of disease-related proteins.