• Regulatory NewsRegulatory News

    EMA Spells Out New Expectations for Adaptive Pathways Applications

    The European Medicines Agency (EMA) has issued a new guidance to help companies applying to its adaptive pathways pilot. Background EMA launched its adaptive pathways pilot in 2014 to speed access to new medicines in areas of "high medical need" by leveraging existing approval pathways to support "early and progressive patient access" to new medicines. Under the pilot, drugs would either be authorized conditionally or in a staggered fashion by narrow indication befor...
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    EMA Issues Draft Guidance on Post-Authorization Efficacy Studies

    The European Medicines Agency (EMA) today issued draft scientific guidance intended to help sponsors design post-authorization efficacy studies (PAES). The guidance, which comes a year after a new regulation, known as the Commission Delegated Regulation (EU) No 357/2014, established circumstances in which EU regulators could require PAES for all medicines. In the past, PAES were typically only required for medicines approved conditionally or under exceptional circumstanc...
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    Report: Competition Quickly Follows First-In-Class Approvals

    By the time "first-in-class" drugs receive marketing approval in the US, nearly all later iterations of those products have begun clinical testing or filed a new drug application with the US Food and Drug Administration (FDA), according to a new study by Tufts Center for the Study of Drug Development. The study, which compared 40 drug classes with a first-in-class approval between 1998 and 2011, found that the race for marketing approval for new classes of drugs and biol...
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    EMA Sets Up Two-Year Pilot Program on Patient Registries

    The European Medicines Agency (EMA) has launched an initiative focused on existing patient registries, with the aim of seeing how they can be better used as a source of post-authorization data, and how they can help to establish new registries. Background EMA defines a registry as a system using observational methods over time to collect uniform data on a population defined by a particular disease, condition, or exposure. A disease registry includes patients bas...
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    Landmark EU Court Ruling Ends Uncertainty Over Duration of Biotech Patent Protection

    Pharmaceutical and biotech companies are cheering a ruling issued earlier this week by the Court of Justice of the European Union (CJEU) that essentially adds up to a couple days' worth of patent protection to medicinal products, but could mean millions of Euros for the companies. The ruling is concerned specifically with Supplementary Protection Certificates (SPCs), which extend the duration of certain rights associated with a patent and are typically provided to compe...
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    EMA Updates Two Pharmacovigilance Guidelines

    Today, the European Medicines Agency (EMA) released two revised guidelines, one final and one draft, to clarify certain aspects of pharmacovigilance in the EU. The two guidelines include a draft version of Module VIII – Post-Authorisation Safety Studies (Rev 2) , which is expected to come into effect in early 2016, and Module IV – Pharmacovigilance Audits (Rev 1) , which takes effect on 12 August 2015. Background Pharmacovigilance is the process of monitoring the use...
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    EMA Looks to Clarify Import Requirements for Finished Products

    The European Medicines Agency (EMA) is looking to expand its guidance for companies importing finished medicinal products to the EU, in response to increasing globalization and supply chain complexity. Importation Requirements In the EU, companies importing finished medicinal products are required to obtain a manufacturing and importation authorisation (MIA) issued by their local national competent authority. To comply with the regulations, importers must follow good ...
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    UK to Launch New Office for Market Access

    The UK's National Institute for Health and Care Excellence (NICE) is launching a new office to promote market access for innovative products through early engagement with companies. A proposal and outline for the Office for Market Access (OMA) was approved by NICE's Board of Directors on 20 May 2015. Background When a new medicine is approved in the UK, NICE is responsible for conducting a health technology assessment (HTA) to measure its cost-effectiveness and determ...
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    EU Committee Wants Additional Restrictions on Codeine Use in Children

    A European committee is recommending a series of restrictions on the use of medicines containing codeine in children. PRAC’s Recommendations Citing concerns that codeine can cause breathing problems and other serious adverse effects in children, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) is recommending codeine be contraindicated for children less than 12 years of age. Additionally, PRAC says that children between ages 12 ...
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    Senators Call for 15 Years of Marketing Exclusivity for Some New Drugs

    • 12 December 2014
    Two US senators have proposed new legislation that would grant an unprecedented 15 years of marketing exclusivity to certain types of pharmaceutical and biopharmaceutical products. Background The bill, known as the Dormant Therapies Act of 2014, is the second piece of legislation introduced in as many days by Sens. Orrin Hatch and Michael Bennet (D-CO). The duo introduced the Promise for Antibiotics and Therapeutics for Health (PATH) Act on 10 December 2014. R...
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    Pharma Company's Phone Script Violates Advertising Regulations, FDA Says

    Those who closely track so-called "Untitled Letters" authored and sent by the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) know the letters most frequently reference promotions made over two types of media: the Internet and print media. But in an unusual letter sent last week by OPDP, the office indicated that it's still keeping an eye on promotions made using a decidedly traditional format: the telephone. An Untitled Letter In i...
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    Even Pharmaceutical Marketing for Dogs can be Improper, FDA Says in Warning Letter

    When the US Food and Drug Administration (FDA) goes after pharmaceutical companies for violating federal marketing regulations, it usually goes after makers of pharmaceuticals for humans. But as a recent and rare Warning Letter illustrates, sometimes veterinary companies fall under the agency's scrutiny as well. In a 2 April 2014 letter to AB Science , a French pharmaceutical manufacturer, FDA veterinary regulators cited the company for allegedly marketing its veterinar...