By 2040, the African Union aims to locally produce 60% of vaccines needed on the continent. To support this goal and the U.S. Government’s Global VAX initiative, PQM+ collaborated with AUDA-NEPAD, the South African Health Products Regulatory Authority (SAHPRA), and Afrigen Biologics and Vaccines to host a four-day workshop designed to build manufacturing and regulatory competencies in Africa. Delegates from more than 15 countries attended, including donors, regulatory agencies, and manufacturers from Burundi, Egypt, Ethiopia, Germany, Ghana, India, Kenya, Nigeria, Rwanda, Senegal, Switzerland, Tanzania, U.K., U.S., and Zimbabwe. The joint workshop featured site visits to South African vaccine manufacturing facilities and panel discussions with speakers from stakeholder organizations, such as the South African Medical Research Council, International Vaccine Institute, and the Medicines Patent Pool. Approximately 200 people attended the hybrid event, which was held in Cape Town.

Addressing Kenya’s most significant health challenges, like malaria, requires quality-assured medicines. To help ensure access, Kenya’s Pharmacy and Poisons Board (PPB) carries out post-marketing surveillance (PMS), a key regulatory function to make sure medical products are safe and effective. PPB launched its PMS technical working group in 2020 with support from PQM+ and USAID. To optimize limited resources, the TWG developed a protocol to conduct risk-based PMS for select malaria and reproductive health, and maternal, newborn, child, and adolescent medical products identified as high risk for being substandard or falsified. 

Working with Kenya’s National Quality Control Laboratory, the PPB then trained staff on RB-PMS sample collection and screening techniques. In one exercise, the PPB collected 299 samples from 18 of Kenya’s 47 counties, shedding light on the quality of the selected medicines in those areas. The PPB found that all the medicines, except for five samples of the de-wormer drug albendazole, met recommended standards. While not nationally representative, the results helped inform regulatory action and the PPB recalled the five affected batches. As such, the PPB has demonstrated ownership of the RB-PMS approach, which will contribute to resource optimization and the sustainability of this important regulatory work.

In many low- and middle-income countries, regulatory information management systems are paper-based, disjointed, or incompatible with other systems, and in some cases nonexistent. PQM+ and the Medicines, Technologies, and Pharmaceutical Services (MTaPS) program collaborated with stakeholders to identify and recommend a set of minimum common standards for regulatory information management systems to make it easier for national medicines regulatory authorities (NMRAs) to manage regulatory data, collaborate with stakeholders, and share information. Adoption of these standards would also enhance NMRAs’ ability to recognize or rely on assessments by the WHO or another stringent regulatory authority, thus preventing duplication of costly processes. Read the call to action.

Uzbekistan speeds access to sources of TB medicines

Swift registration of quality-assured TB medicines is critical to ensuring a reliable supply of life-saving drugs in Uzbekistan, which has one of the highest burdens of multi-drug resistant TB in the world. The WHO collaborative procedure for accelerated registration of prequalified medicines (CPAR) is an effective mechanism for helping countries optimize resources and ensure timely and efficient registration of essential medicines, including those used to treat TB. As a result of PQM+ technical support, Uzbekistan used CPAR to register two WHO-prequalified TB medicines, cycloserine and prothionamide. These medicines are particularly valuable because they are second-line TB treatments, which means they offer alternatives to patients who have not responded to standard, first-line treatment. The expedited registration of these medical products may also encourage manufacturers to register other TB products in Uzbekistan, and improve access to additional important medicines.

Multiple labs achieve accreditation milestones

Nine national quality control laboratories received reaccreditation under ISO 17025:2017 in countries where PQM+ works. This accreditation details requirements to ensure laboratories operate competently, impartially, and consistently. Reaccreditation is a measure of sustainability because it indicates a country is investing in its public health laboratory networks, which form the backbone of the medicines regulatory system. Labs achieving reaccreditation include: Burma’s Nay Pyi Taw pharmaceutical chemistry lab; Ethiopia’s Product Quality Assessment Directorate lab; and Nigeria’s three National Agency for Food and Drug Administration and Control labs and National Institute for Pharmaceutical Research and Development lab. Tajikistan’s lab in Dushanbe upgraded its ISO 17025 accreditation to the 2017 standard. Three other labs, including Bangladesh’s physiochemical laboratory, Nigeria’s vaccines and biologics lab, and Uzbekistan’s Tashkent lab, were reaccredited, with an expanded scope of methods.

This fall, PQM+ supported 37 manufacturers from 11 countries that are pursuing 61 product authorizations or WHO prequalification. These manufacturers are working to produce medicines to improve maternal, neonatal and child health, and to prevent or treat neglected tropical diseases, malaria, and TB. Most of PQM+’s support is for finished pharmaceutical products, which are the medicines taken by patients, with some support for production of active pharmaceutical ingredients (APIs), the ingredients that cause a medicine’s desired effect. PQM+ supports local pharmaceutical manufacturers to help them comply with good manufacturing practices and ensure the medicines they produce meet standards for quality, efficacy, and safety. Product authorizations or WHO prequalification speed up the process of purchasing and using medical products.