Analysis of Timelines for EAC Joint GMP Inspections, 2016-2022: A Pathway for Regulatory System Strengthening in Africa and Capacity Building of Less Resourced National Regulatory Authorities (NRAs)

Jane Humphrey Mashingia^1*Noel Aineplan²Kari L Clase^1*Steven Bryn¹Zita Ekeocha¹

• ¹Purdue University, West Lafayette, United States
• ²National Drug Authority, Kampala, Uganda

The East African Community (EAC) National Medicines Regulatory Authorities (NRAs) have been collaborating to conduct joint GMP inspections. This study was conducted to (a) assess the joint GMP inspection procedure, (b) determine key milestones and target timelines, (c) identify areas of improvement and opportunities for capacity building, and (d) understand the contribution of EAC joint GMP inspections to the operationalization of the African Medicines Agency (AMA). The results indicated that 37 pharmaceutical manufacturing facilities located in Africa, Asia, and Europe were jointly inspected (35 physical inspections and 2 desk reviews) between 2016 and 2022. The inspected facilities manufactured vaccines, non-beta-lactam tablets/capsules, sterile products. 8% of the inspected facilities failed to meet the GMP standards. Timelines for key milestones of the joint GMP inspection procedure indicated that the overall scheduling of joint GMP inspections took more than 14 workdays: 57 days in 2018, 24 days in 2019, 43 days in 2020, and 28 days in 2022. Median time for planning EAC joint GMP inspections was consistent with the set timeline of 30 days. However, in 2017, the median time was 40 days. All physical inspections between 2016 and 2022 were conducted within the median timeline of 3 days; nevertheless, the median time for GMP report writing in 2016 was 16 days, slightly higher than the set timeline of 14 days. The findings further indicate that manufacturing facilities (applicants) take a long time to submit CAPA, which should be completed within 90 days. The median timelines for the submission of CAPA were 135 and 125 days in 2018 and 2019, respectively. The EAC GMP inspections have been used as a tool/model for capacity building of less-resourced NRAs through a twinning program. These NRAs have benefited from learning and acquiring practical skills, as well as building confidence and trust in each other. This model is fit for adoption at the continental level by the AMA and the African Medicines Regulatory Harmonisation Programme to promote reliance, convergence, and harmonization. This study identified several gaps, including incomplete data in the metric tool and a lack of monitoring and capturing timelines for joint GMP desk assessments.