rtificial intelligence (AI) and machine learning (ML) are set to revolutionize pharmacovigilance (PV), the science of identifying, evaluating, and preventing adverse drug reactions (ADRs). The landscape of drug safety is rapidly evolving, demanding innovative approaches to PV. Traditional PV systems struggle to keep the pace with increasing volume and complexity of clinical trial and healthcare data. There are many promising use cases of AI/ML enhancing the efficiency, accuracy, and timeliness of drug safety monitoring. However, the implementation of AI/ML presents several significant challenges. These include ensuring data privacy and security, mitigating model bias, establishing robust model validation processes, navigating complex ethical implications, and developing clear, globally harmonized regulatory standards.

t is important to be mindful about how we apply statistical methods during the evaluation of safety data, as key misapplications of statistics can be found during both clinical development and in the post-marketing space.

ene therapy offers hope for patients suffering from rare genetic diseases long considered untreatable beyond symptom management. The therapy involves using genetic material to treat diseases by functionally repairing or replacing missing or damaged genes. Several gene therapies have gained Food and Drug Administration (FDA) approval in recent years, with a wave of new therapies predicted in the coming years. As of early 2025, the FDA has approved over 30 cell and gene therapies, and industry experts anticipate 30-50 additional cell and gene therapy approvals by 2030.

he eCTD v4.0 standard has been available to be used for submissions to any ICH-participating regulatory agency since 2015, when it reached Step 4 in the International Council on Harmonisation (ICH) process. However, 10 years later, only Japan and the US have begun optional use of the new version.

takeholders’ intentions in partnering in the healthcare space can range widely but often include sharing resources, collaborating to take new risks, achieving mutual benefit, and providing greater societal good. Such stakeholders include representatives from pharmaceutical companies, other health-related industries, regulatory bodies, academia, industry, patient groups, and HTAs. They see partnerships as necessary to overcome the complexity of problems facing the health sector and to sustain positive outcomes. However, several challenges get in the way of effective partnering.

ultiregional clinical trials (MRCTs) enable simultaneous drug evaluation across diverse populations while meeting international regulatory standards. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E17 guideline on MRCTs introduced in 2017 provides a framework for optimizing MRCT design and execution. In recent years, China has emerged as a key player in implementing these guidelines, integrating international standards into its regulatory framework and industry practices. Through collaboration among regulators, academia, and industry, China is strengthening its role in advancing simultaneous global drug development. Since the introduction of ICH E17, progress has been evident in the global implementation of MRCTs, although certain obstacles remain.

ehind every successful global clinical trial are the people who deliver it, the processes that sustain it, and the precision that defines it. This case study reveals how an international site network worked to sustain operational excellence in a recent osteoporosis study.

he adoption of Good Regulatory Practices (GRPs) is fundamental to strengthening countries’ regulatory capacity and ensuring that pharmaceutical product regulation aligns with international standards. The promotion of GRPs by regulatory authorities and other key stakeholders, such as the pharmaceutical and health innovation industry, is essential to improve regulation quality, foster public trust, and facilitate international harmonization and cooperation in every region. But in one specific region, Latin America, the adoption of GRPs is uneven and not universal, thus hampering the alignment of all of Latin America with international standards.

s Saudi Arabia continues its ambitious healthcare transformation under Vision 2030, the Ministry of Health is playing a central role in reimagining the nation’s approach to health and wellness. Fahad bin Abdulrahman AlJalajel, His Excellency, the Minister of Health, outlines key milestones in the shift toward a value-based healthcare system, including the creation of the Health Holding Company and regional health clusters. AlJalajel also explores the role of digital health and AI, the expanding impact of public-private partnerships, and the kingdom’s strategy to become a global biotech hub by 2040. Additionally, he discusses how Saudization is shaping the healthcare workforce of the future and Saudi Arabia’s emerging role as a leader in global health diplomacy.