Access to quality-assured medical products improves health and save lives. However, one third of the world’s population lacks timely access to quality-assured medicines while estimates indicate that at least 10% of medicine in low- and middle-income countries (LMICs) are substandard or falsified (SF), costing approximately US$ 31 billion annually. National regulatory authorities are the key government institutions that promote access to quality-assured medicines and combat SF medical products but despite progress, regulatory capacity in LMICs is still insufficient. Continued and increased investment in regulatory system strengthening (RSS) is needed. We have therefore reviewed existing global normative documents and resources and engaged with our networks of global partners and stakeholders to identify three critical challenges being faced by NRAs in LMICs that are limiting access to medical products and impeding detection of and response to SF medicines. The challenges are; implementing value-added regulatory practices that best utilize available resources, a lack of timely access to new, quality medical products, and limited evidence-based data to support post-marketing regulatory actions. To address these challenges, we have identified seven focused strategies; advancing and leveraging convergence and reliance initiatives, institutionalizing sustainability, utilizing risk-based approaches for resource allocation, strengthening registration efficiency and timeliness, strengthening inspection capacity and effectiveness, developing and implementing risk-based post-marketing quality surveillance systems, and strengthening regulatory management of manufacturing variations. These proposed solutions are underpinned by 13 focused recommendations, which we believe, if financed, technically supported and implemented, will lead to stronger health system and as a consequence, positive health outcomes.

There is broad agreement among health-care stakeholders that more must be done to ensure that patients have timely access to new and innovative medicines. Assuming that industry will continue to develop such medicines at a sustainable rate, regulators and payers become the gatekeepers. Regulators, starting in the late 1980s/early 1990s, and, more recently, payers have implemented a variety of early-access pathways or initiatives, and this practice is continuing even today. This article describes the specific approaches that have been taken in four economically developed regions, reviews their success rates, and suggests possible new directions.

Artificial Intelligence (AI) has shown remarkable potential to revolutionise healthcare by enhancing diagnostics, improving treatment outcomes, and streamlining administrative processes. In the global regulatory landscape, several countries are working on regulating AI in healthcare. There are five key regulatory issues that need to be addressed: (i) data security and protection—measures to cover the “digital health footprints” left unknowingly by patients when they access AI in health services; (ii) data quality—availability of safe and secure data and more open database sources for AI, algorithms, and datasets to ensure equity and prevent demographic bias; (iii) validation of algorithms—mapping of the explainability and causability of the AI system; (iv) accountability—whether this lies with the healthcare professional, healthcare organisation, or the personified AI algorithm; (v) ethics and equitable access—whether fundamental rights of people are met in an ethical manner. Policymakers may need to consider the entire life cycle of AI in healthcare services and the databases that were used for the training of the AI system, along with requirements for their risk assessments to be publicly accessible for effective regulatory oversight. AI services that enhance their functionality over time need to undergo repeated algorithmic impact assessment and must also demonstrate real-time performance. Harmonising regulatory frameworks at the international level would help to resolve cross-border issues of AI in healthcare services.

As large numbers of candidate drugs and vaccines for potential use in the coronavirus disease 2019 (COVID‐19) pandemic are being investigated, medicine regulators globally must now make urgent, informed, contextually risk‐1based decisions regarding clinical trials and marketing authorizations. They must do this with the flexibility demanded by the pandemic while maintaining their core risk assessment and public safety functions. We lay out the critical role of regulators in the current crisis and offer eight “pandemic best regulatory practices.” These should support both the regulatory public heath imperative and assure timely patient access to effective, safe, quality products worldwide during this emergency—thus contributing to ending this pandemic as quickly, effectively, and safely as possible.