Regional Comparisons
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Exclusive analyses of drug review trends, approval decisions and regulatory guidance across regions.
Parallel Scientific Advice: Is The EMA User Fee Impacting Interest?
EMA charges participants to receive scientific advice through the fledgling program, unlike the US FDA, which may not fit the budgets of some complex generic sponsors. At the same time, sponsors also may simply not be aware the program exists yet.
For Generics, EU Reference Product Is Non-Negotiable – Even In Pilot On Parallel Advice
Acknowledging that it may be a barrier to some extent, EMA’s senior scientific specialist of clinical pharmacology Kevin Blake notes that EU reference medicinal products are a legal requirement for bioequivalence studies and cannot be circumvented.
How The EU & UK’s Contrasting Approaches To AI Regulation Could Impact Pharma
While EU preparations are underway to introduce strict legal requirements for all AI systems, the UK has doubled down on its flexible, non-regulatory framework. In this second of a two-part article, a lawyer explains the pros and cons of each for pharma and medtech firms.
For Psychedelics, US FDA Is Open To Creative Thinking But Firm On Approval Standards
Flexible thinking and rigorous standards will both be needed to develop psychedelics as drug therapies in order to surmount the many complicating factors, from unique ‘set and setting’ aspects to functional unblinding, speakers at Reagan-Udall Foundation meeting agree.
FDA-EMA Pilot Advice Scheme On Complex Generics Sees Slow Uptake
While approaching the third year of its launch, the parallel advice program has seen a handful of applicants, but regulators on both sides of the Atlantic remain optimistic.
Regulatory Reliance Pathways: Challenges And Opportunities Ahead
International interest in fast-track regulatory reliance and collaboration pathways such as Project Orbis and the ACCESS Consortium has grown in recent years, a trend that looks set to continue in 2024. But some policy experts have warned that faster approvals are not always better, with one academic claiming the bar for marketing authorizations has dropped “far too low.”
Project Orbis 2023: FDA Approves Six New Cancer Drugs, But Partner Nations Lag Behind
Sixteen cancer therapies have been granted marketing authorizations or label variations in the US this year via the Project Orbis scheme. However, the majority of these are still under review by Orbis partners, which have also been outpaced by the non-Orbis EU.
Watching The Clock Stop: US/EU Regulatory Review Time Parity In Sight, Study Suggests
European Union reform proposals could reduce ‘clock stop’ time in drug reviews, which a new study identified as the primary driver of longer review times at the EMA compared with the US FDA.
International Regulators Say Collaboration Is Key To Tackling Pharma Globalization Challenges
Regulators from Canada, the UK and Australia discuss their experiences of working together under both the ACCESS Consortium, an international regulatory worksharing coalition, and Project Orbis, a parallel review process designed to speed up access to oncology medicines.
Project Orbis: More Cancer Drugs Available In Scotland Than England
The UK joined Project Orbis in 2021 with the aim of speeding up the regulatory process for promising cancer drugs, but fewer than half of the drugs licensed under this pathway are available on the NHS in England.
EU-US-Japanese Pharmacopeia Group Accepts India As First New Member in Decades
The move expands access to the Pharmacopoeial Discussion Group’s quality standards to the Indian pharmaceutical industry.
Scotland First To OK Reimbursement For MSD's Welireg, But Situation In England Remains Unclear
The SMC, the Scottish health technology assessment body, has approved reimbursement for the first drug to win an innovation passport from the UK regulator.
Scotland Fast Tracks HTA For AbbVie’s Aquipta While England Switches To Lengthier Process
Scotland’s health technology assessment body has beaten its counterpart in England to approving AbbVie’s migraine treatment Aquipta for reimbursement on the National Health System.
Gene Therapy HTA: How Do The European, Australian And Canadian Systems Shape Up?
A report comparing the health technology assessment methods used in nine European countries, Australia and Canada found that England has the most favorable reimbursement landscape for gene therapies – but outlined several areas for improvement across the board.
Swiss New Drug Approval Times On A Par With EMA, But Longer Than US FDA
The median approval time for new drugs in Switzerland lengthened in 2022, mainly because of applications filed during the peak of the COVID-19 pandemic, says the country’s regulator.
How Do Japan’s Clinical Trial eConsent Rules Compare With The EU And US?
A newly-translated guidance document from Japan’s drug and device regulator outlines the points that clinical trial sponsors should consider when using electronic methods to collect informed consent from participants.
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