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  • Regulatory NewsRegulatory News

    Japan Edges out FDA for Fastest Approvals

    In 2014, Japan's regulator, the Pharmaceuticals and Medical Devices Agency (PMDA) edged out the US Food and Drug Administration (FDA) as the world's fastest regulator, with a median approval time of 306 days for new active substances (NASs). New Drug Approvals in ICH Countries A new report by the Centre for Innovation in Regulatory Science (CIRS), New Drug Approvals in ICH Countries 2005-2014 , examines NAS approvals in the US, EU and Japan. The report finds that FD...
  • Regulatory NewsRegulatory News

    What's a 'New' Drug in the EU? EMA Explains

    When is a chemical entity considered a new active substance (NAS)? The European Medicines Agency (EMA) answers that question and provides clarification on the type of information required to demonstrate that a substance qualifies for NAS status in a draft reflection paper published Friday. Background Obtaining NAS status is important for drug makers, as products granted NAS status benefit from a full 10 years of protection against generic competition. However, to ensur...
  • Regulatory NewsRegulatory News

    Bill Wants Drugs Approved in Europe to be Available More Quickly to US Patients

    New legislation introduced in the US House of Representatives this week would require the US Food and Drug Administration (FDA) to expedite the review and approval of pharmaceutical products already approved in Europe. Background The bill, the Speeding Access to Already Approved Pharmaceutical Act , is sponsored by Reps. Tim Ryan (D-OH) and Steve Stivers (R-OH), who introduced the same bill in June 2014 . As with the original, the bill targets something known in th...