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Stakeholders are urging the US Food and Drug Administration (FDA) to be flexible in how it regulates psychedelic drugs that may help treat conditions such as major depressive disorder (MDD) and post-traumatic stress disorder (PTSD). The agency should be careful not to create unnecessary barriers to patient access, promote proper training and credentialing, and allow flexibility in updating labeling as additional knowledge becomes available, according to individuals and groups that commented via a public docket.

The number of clinical trials authorized in the EU and European Economic Area (EEA) has decreased by 13.5% from pre-pandemic levels as Asia has captured a growing share of clinical research.

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) is planning to update a 2018 guideline on good pharmacogenomic practices. While the guideline is less than a decade old, the pace of change in pharmacogenomics has prompted regulators to revisit their recommendations.

The US Food and Drug Administration (FDA) is seeking public input on how to design early-phase clinical trials to evaluate therapeutic uses of the plant-derived psychoactive drug ibogaine.

The International Coalition of Medicines Regulatory Authorities (ICMRA) issued a joint statement encouraging manufacturers and national control laboratories to reduce animal testing throughout the lifecycle of medicines. ICMRA also encouraged regulators to challenge any proposals that suggest using animals for batch release testing.

The Council of the European Union has adopted new rules for the pharmaceutical sector, advancing efforts to reform legislation governing the industry.

CHARLOTTE, NC — Whether the US Food and Drug Administration (FDA) will accept clinical evidence from outside the United States (OUS) depends on if the investigations followed good clinical practice (CGP) regulations, but the data should also be applicable for regulatory purposes.

Emer Cooke and other EMA leaders have weighed into the debate about whether sponsors should run one or two pivotal trials, arguing that the decision should be informed by the evidence needed to show a positive benefit-risk balance.

CHARLOTTE, NC — While new approach methodologies (NAM) offer a path to reduced reliance on animal testing, experts say global regulators need to agree on their use to give sponsors predictability and regulatory assurance.

CHARLOTTE, NC — Regulators and industry experts stressed the need for regulatory harmonization around artificial intelligence (AI) to ensure the technology is used responsibly in drug development during a panel discussion at RAPS Convergence 2026.