• Regulatory NewsRegulatory News

    ICH Offers Updates on New Members, Progress on Guidelines

    The International Council on Harmonisation (ICH) has added new observers and members, as well as updates on different guidance documents discussed at its November meeting in Japan, according to meeting minutes released Wednesday. New members approved at the meeting were Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), the US industry group Biotechnology Innovation Organization (BIO) and Korea’s Ministry of Food and Drug Safety (MFDS). In terms of observers, ...
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    European Commission Clears First Enbrel Biosimilar Ahead of US

    The European Commission over the weekend signed off on the first biosimilar for Amgen’s blockbuster rheumatoid arthritis treatment Enbrel, a version of which is also making its way through a separate review by the US Food and Drug Administration (FDA). With almost $5 billion in annual sales last year (and almost $9 billion in 2014 sales), the biosimilar version of the treatment from Samsung Bioepis, known commercially as Benepali (etanercept), could help to drive down pr...
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    Key Changes to South Korean KGMP, IVD Regulations Set for 2015

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. South Korean medical device regulators will implement significant changes affecting compliance requirements for  in vitro  diagnostic (IVD) registration as well as for Korean Good Manufacturing Practice (KGMP) audits over the course of 2015. According to Emergo consultants in Seoul, officials at the South Korean Ministry for Food and Drug...