Regional Comparisons
Lawyers from Sidley Austin tell the Pink Sheet how European drug manufacturers and marketing authorization holders should proactively deal with warning letters from the US Food and Drug Administration.
India issues firm advisory on promos for obesity and metabolic disorders therapies ahead of loss of exclusivity for semaglutide later this week, with 50-plus generic brands seen in the wings for a share of the pie. Will Eli Lilly and Novo Nordisk have to tweak their multimedia campaigns?
Strengthening the European Medicines Agency’s capacity to analyze clinical and non‑clinical raw data, expanding real-world evidence infrastructure, and boosting AI literacy across the EU regulatory network all feature prominently in a new 2026–2028 workplan.
Clinigen's CEO and senior executives outline how the services company navigated Japan’s rigorous regulatory framework to secure approval for Prolacta’s human milk–based fortifier as a prescription biological product.
Parexel’s CEO Peyton Howell and India chief Sanjay Vyas talk to the Pink Sheet about clinical trials amid global turmoil, the slowdown in big pharma decision-making and pivot in some cases to the FSP outsourcing model, evolving DCT definitions and India opportunities.
A regulatory sandbox and greater global harmonization will not only improve pathways for Indian cell and gene and other advanced therapies to reach the UK’s National Health Service but also speed up approvals in India
Platform technologies in the EU are set to benefit from greater regulatory flexibility under the upcoming EU pharma legislation overhaul. Industry is urging policymakers to “avoid misalignment” with other global regulators, including in the US.
From enforcing new GMP norms to risk-based inspections and 850 CAPA notices, India’s drugs regulator is moving to tighten compliance across domestic pharma units. A striking step up in the regulator’s internal scientific cadre and more regulatory rationalization are also on the cards.
The third complete response letter (CRL) from the US Food and Drug Administration for Outlook Therapeutics’ wet age-related macular degeneration (wAMD) drug is the latest instance of the agency requiring more confirmatory evidence than prior expectations for an eye disease treatment.
A new report identifies opportunities to implement the 3Rs principle in India, calling for a waiver of redundant animal testing for generics and NCEs/NBEs and alignment with global regulatory frameworks. Will India shift gears to adopt harmonized NAM-first policies?
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.