• Regulatory NewsRegulatory News

    FDA issues new MAPP on reviewing color additives

    The US Food and Drug Administration’s Office of Pharmaceutical Quality (OPQ) issued a new Manual of Policies and Procedures (MAPP) describing the agency’s internal procedures for reviewing color additives and flavors in new drug applications, supplements, and Type IV drug master files and how these reviews will be coordinated with the Office of New Drugs (OND).   The 12-page MAPP identifies the responsibilities of quality assessors in conducting these reviews and addre...
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    Swissmedic Touts 2016 Performance: 42 New Approvals

    In its annual report released Tuesday, Swiss drug regulator Swissmedic says it outpaced the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) in approving new drugs in 2016, in part due to the agency's new fast-track procedure. In 2016, Swissmedic approved 42 new active substances (NASs), a 50% increase over the previous year and just over 50% more than EMA recommended. "This increase shows that the pharmaceutical industry in Switzerland is conti...
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    Updated: FDA and EMA in 2016: A Look at the Numbers

    The US Food and Drug Administration (FDA) wasn't the only major regulator to OK fewer new drugs in 2016 than in recent years. Across the Atlantic, the European Medicines Agency (EMA) saw a similar decline in the number of drugs, with only 27 new active substances (NASs) recommended. In fact, both regulators saw the lowest number of new drugs given a positive review in their respective jurisdictions in years. For EMA, the number represents the fewest NASs recommended in a...
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    FDA Offers New Bioequivalence Recommendations for 31 Active Ingredients, 13 Revisions

    The US Food and Drug Administration (FDA) on Thursday announced the latest batch of new draft guidance for the generic drug industry with 31 product-specific bioequivalence (BE) recommendations and 13 revisions to prior recommendations. The recommendations, which have been released on an ongoing basis since 2010, provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). The new guidance is for the following activ...
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    EMA's 2015 Annual Report: Interest in Scientific Advice Increasing

    The European Medicines Agency (EMA) on Tuesday released its Annual Report 2015 touting its performance and key achievements for the year. According to Sir Kent Woods, former chair of the EMA Management Board, 2015 was a year of transition for the agency. In November 2014, EMA Executive Director Guido Rasi's appointment was annulled , leaving the agency without a head until November of the following year when Rasi was re-appointed . Despite the disruption to EMA's le...
  • Feature ArticlesFeature Articles

    Worksharing in the Evaluation of Active Substances

    This article describes ongoing procedures and initiatives for 'worksharing' in the evaluation of active substance dossiers by regulatory authorities around the world. Introduction An Active Substance or Drug Master File (ASMF/DMF) can be used to describe the chemistry, manufacture and controls for an active substance. It is typically divided into an applicant's or open part and a restricted or closed part. The applicant's part is provided to the Marketing Authorizatio...
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    Woodcock: Drug Safety Surveillance System Ready for Full Operation

    The US Food and Drug Administration's (FDA) Sentinel database tracking medical product safety events is now an "integral part of routine safety surveillance," Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at FDA said at the 8 th Annual Sentinel Initiative Public Workshop in Washington, DC, Wednesday. "We can, as of today, officially drop 'Mini' from the Sentinel title," she said, noting the progress made since the agency began transition...
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    FDA Offers New Bioequivalence Study Guidance for 31 Generic Drug Ingredients

    To help the generic pharmaceutical industry identify the most appropriate ways to generate evidence needed to support abbreviated new drug application (ANDA) approval, the US Food and Drug Administration (FDA) has published draft product-specific recommendations for 31 different active pharmaceutical ingredients (APIs) and revised recommendations for 11 APIs. The myriad new draft guidance documents focus on what types of bioequivalence (BE) studies may need to be conduct...
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    EMA Carries 2014 Momentum, Recommends 39 New Drugs and Sets Orphan Record

    In 2015, the European Medicines Agency (EMA) maintained its momentum from 2014 , granting 93 positive opinions, 39 of which were for new active substances. The agency also recommended 18 orphan drugs for approval, breaking last year's record of 17. Notably, EMA trailed just behind the US Food and Drug Administration (FDA)'s Center for Drug Evaluation and Research (CDER) for the year. In 2015, CDER approved 45 new drugs, 21 of which had been granted orphan drug designati...
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    FDA Inaction Pushes McCaskill to Target Picamilon Retailers Directly

    Sen. Claire McCaskill (D-MO) is calling on ten major retailers to pull all supplements containing the ingredient picamilon after what she says has been “weeks of inaction” by the US Food and Drug Administration (FDA). The letters sent Monday to Amazon, the Vitamin Shoppe, CVS, Wal-Mart, Google, Vitamin World, Walgreens, Target, eBay and General Nutrition Corporation (GNC) call on them to pull from their shelves any dietary supplements containing picamilon as FDA has decl...
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    FDA Bans Imports From Major Indian API Manufacturer

    The US Food and Drug Administration (FDA) on Wednesday added Indian active pharmaceutical ingredient (API) manufacturer Megafine Pharma's Nashik site in Maharashtra, India, to a list of foreign manufacturing sites banned from sending products to the US. Megafine, which was hit with an FDA Form 483 back in May at the site, produces 24 APIs for the US market , including for drugs intended to treat Alzheimer's disease, depression, schizophrenia, multiple sclerosis and over...
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    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...