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Beyond the certificate: falsification-resistant GMP compliance for low- and middle-income countries
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DOI：10.1080/20523211.2026.2677782.png)
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Abstract
En 中文
In numerous low- and middle-income countries (LMICs), good manufacturing practice (GMP) compliance frameworks ostensibly mirror those of stringent regulatory authorities (SRAs). In practice, limited enforcement capacity and corruption-susceptible inspection systems render facility certificates unreliable indicators of quality.
This conceptual policy design article proposes a tier-based, product-centric compliance platform intended to deliver measurable patient protection under constrained regulatory capacity, incorporating falsification-resistant evidence requirements and anti-corruption design features benchmarked against the FDA, EU, PIC/S, and WHO Prequalification Program frameworks.
The article is positioned as a conceptual policy design framework rooted in structured comparative regulatory analysis, rather than a systematic review or empirical evaluation. It draws on enforceable regulations, ICH guidelines, FDA and EU guidance, PIC/S inspection standards, WHO and WHO/UNODC reports, WHO Global Surveillance and Monitoring System (GSMS) data, and peer-reviewed evidence on substandard and falsified (SF) medicines. Sources were purposively selected, favouring enforceable regulation, documented clinical or mortality outcomes, and official reports from organisations with direct regulatory authority.
The platform functions through three consecutive tiers. Tier 1 mandates verification of raw material and excipient equivalence as a prerequisite for market eligibility ($500 to $2,000 per product dossier). Tier 2 implements recorded remote regulatory assessments (recorded RRAs) aligned with the FDA's RRA framework and PIC/S practices, incorporating engineered anti-staging and anti-falsification countermeasures. Tier 3 allocates risk-based onsite inspections for high-risk operations and escalation triggers. A minimum viable product (MVP) configuration is delineated for regulators unable to implement the full platform immediately, limiting Tier 1 to critical excipients with a documented history of mass-casualty incidents, and Tier 2 to pediatric oral liquids and sterile injectables, at approximately 30 to 40 per cent of the total platform cost. An analysis of political economy and stakeholder incentives identifies resistance scenarios at the inspector, manufacturer, procurement agency, and regulator levels, each paired with embedded mitigation strategies. A pre-registered, stepped-wedge pilot evaluation framework is proposed, featuring predefined effect-size thresholds and a non-equivalent control series.
A product-centric, evidence-linked compliance platform offers a viable pathway toward measurable patient protection in corruption-exposed environments, provided feasibility constraints, political economy barriers, and equity considerations are addressed during implementation design. Future efforts should prioritise pilot studies, cost-effectiveness modelling, and structured stakeholder consultation.
Keywords:
GMP
substandard and falsified medicines
LMIC regulation
remote regulatory assessment
data integrity
regulatory capture
pharmaceutical supply chain
WHO Prequalification
PIC/S
pilot evaluation
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