Regional Comparisons

If the EU’s controversial Artificial Intelligence Act applies restrictive rules to pharmaceutical research and development activities, the UK could benefit from offering a more favorable regulatory environment, top lawyer Stephen Reese explains.

While drug manufacturers are unlikely to “pull out of the EU entirely,” geopolitical shifts driven by US tariff threats will mark a “categoric shift” as big pharma tries to “placate the Trump administration,” an analyst says.

Human-centric design, a risk-based approach and lifecycle management are among the ten guiding principles for artificial intelligence (AI) that pharma should follow when using AI in the drug lifecycle, the FDA and EMA say in a joint document.

New approach methodologies are increasingly shaping the future of medicine development by making drug testing less reliant on animals.

India is advancing regulatory rationalization efforts, refining procedures and pathways. Guidelines for biosimilars are expected to align with international standards, while early steps towards PIC/S compliance have been initiated.

Horizon scanning is a tool used by regulators to prepare for forthcoming medicines that might challenge existing processes. Senior figures from the European Medicines Agency, Swissmedic and the UK MHRA explain how they conduct horizon scanning activities in their respective jurisdictions.

Real-world evidence (RWE) studies in India face challenges like lack of data reliability and uniformity and absence of clear guidelines but firms like Bharat Serums have scored a regulatory win. Pink Sheet examines the RWE landscape and the BSV case study for lessons in beating the odds

Regeneron’s odronextamab faced regulatory hurdles in the US due to trial and manufacturing issues, while it secured a smooth approval in Europe, offering key lessons to sponsors on how to navigate global submissions.

While both ISRCTN and ClinicalTrials.gov will meet the UK’s upcoming clinical trial registration requirements, sponsors are being advised to register their studies with ISRCTN unless there is a specific requirement from the US Food and Drug Administration to use ClinicalTrials.gov.

This second of a two-part series of articles on accelerated assessments and priority reviews explores why the EU mechanism remains underused compared to its US counterpart, how it might be improved, and how sponsors can improve their chances of securing an expedited drug review in Europe.

This first of a two-part article on expedited drug review mechanisms explores how often EU accelerated assessments are granted compared to US priority reviews. Among other things, it shows how the US regulator often grants expedited reviews to products that the EU regulator refuses to fast track.

Legal and other experts discuss the need to plug data privacy and regulatory gaps and address prescription shortcuts at e-pharmacies. Collaborative models with brick and mortar chemists were also proposed.

Minoryx explained to Pink Sheet why it believes its resubmission for leriglitazone stands a stronger chance of approval, and highlighted the value of early dialogue with the regulators when it comes to rare diseases, where the understanding of the natural history and outcomes is often limited.

The European Medicines Agency’s ongoing pilot to streamline drug reviews by allowing companies to voluntarily pre-fill factual data in assessment report templates appears to add significant workload for industry, without delivering clear value to regulators.

Reforming clinical trial regulations, addressing the use of artificial intelligence, mitigating medicines shortages and strengthening ties with other drug regulators are key priorities for Australia’s Therapeutic Goods Administration over the next year.

Companies can propose specific issues for discussion during the regulators’ monthly teleconferences, which focus on finding areas of agreement and reasons for nonalignment on specific pediatric development plans or general issues.

Roche’s filing for Elevidys in the EU followed applications in Middle Eastern countries because those markets accept applications based on approval by the US Food and Drugs Administration.

An ongoing proof-of-concept study by the European Medicines Agency testing the use of US-style standards for submitting non-clinical raw data in marketing applications has received positive feedback from both industry and regulatory assessors so far.

Sponsors should investigate signals of possible fraud in a manner that does not raise alarms or else evidence might disappear, UK and US regulators said.

The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US.