Abstract:
Background: The National Quality Infrastructure (NQI), as a critical infrastructure supporting
quality improvement, plays a pivotal role in ensuring products meet safety, efficacy, and quality
standards. As Ethiopia strives to expand domestic pharmaceutical production, effective National
QI services become crucial for ensuring product quality, regulatory compliance, and
international market access. This study evaluates the current status of NQI service provision for
Ethiopia’s pharmaceutical manufacturers, identifies challenges, and proposes solutions.
Methods: A qualitative study design was employed, utilizing in-depth interviews guided by semi
structured interview questions, along with flexible probing techniques for data collection.
Participants were purposefully selected from key stakeholders, including managers from local
pharmaceutical companies, officials from national quality infrastructure elements, and the
Ethiopian Food and Drug Authority. All transcriptions of the interviews underwent thematic
analysis and the NVivo® 14 coding software was used for data analysis.
Results: A total of 22 participants were involved in this study, from which four themes emerged:
manufacturers' current demands, their capacity, challenges in delivering NQI services, and
proposed solutions. This study reveals critical gaps in Ethiopia’s National Quality Infrastructure
(NQI) for the pharmaceutical manufacturing sector, including inadequate metrology services,
weak policy enforcement, and poor institutional coordination. Limited industry awareness,
resource constraints (funding, skilled staff), and insufficient private sector involvement further
strain NQI providers like EMI, delaying services. To overcome these obstacles, participants
emphasized the need to expand private-sector engagement in testing and calibration service
provision, improve cooperation between NQI institutions and regulatory bodies in creating
awareness, and integrate quality infrastructure priorities into the education and policy systems.
Conclusion: This study highlights strategic interventions, including private sector engagement,
stronger collaboration between regulators, and policy integration, as critical to addressing the
challenges in Ethiopia’s NQI service provision for the pharmaceutical industry. Implementing
these measures would strengthen local pharmaceutical production capabilities, which align with
Ethiopia’s broader ambition for the sector.