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    European Commission Consults on Orphan Drug Applications

    The European Commission on Tuesday launched a targeted consultation to provide input on a revision of its guideline on the content and format of applications for orphan drug designation, as well as the transfer of designations between sponsors.   "The comments received will be taken into account by the European Commission in the finalization of the guideline on the format and content of application for designation as orphan medicinal products and on the transfer of des...
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    European Commission Updates Q&A on Safety Features for Medicinal Products

    The European Commission recently released an updated document setting out nine new and one revised frequently asked questions and answers on the implementation of the rules on the safety features for medicinal products for human use. Building off a previous update in November , five of the new questions deal with general issues, like whether medicinal products can carry more than one batch number, or whether during the transitional period manufacturers located in the E...
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    UK Looks to Ensure Pharma Submissions Can Continue Under No Deal Brexit

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is preparing to ensure that if the UK leaves the EU without a deal, pharmaceutical companies can continue to submit regulatory and notification information to the UK. “If the UK leaves the EU with no deal, the UK would no longer be part of the EU medicines and medical devices regulatory networks. Submissions related to human medicines would need to be submitted directly to the MHRA,” the agency said. ...
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    Falsified Medicines Directive: MHRA Responds to Comments, Addresses Brexit Impact

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) last month responded to comments on its proposal to implement packaging safety features under the EU Falsified Medicines Directive (FMD) .   The safety features, which include requiring a unique identifier comprised of a 2D data matrix code and human readable information and an anti-tampering device on the packaging of certain medicines, are detailed under Commission Delegated Regulation (EU) 2016/16...
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    EMA Recommends When Drugmakers Should Consult With Pediatric Research Network

    The European Medicines Agency (EMA) on Monday released recommendations from its European network of pediatric research (Enpr)-EMA working group on opportunities during various stages of development to consult with pediatric research groups.   “Enpr-EMA suggests that all companies consider using these opportunities in a spirit of shared learning about the best way to collaborate during [pediatric investigation plan] planning,” EMA writes, noting that companies can benef...
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    ABPI Questions Lack of Details in Latest UK Update on No-Deal Brexit

    The UK’s Secretary of State for Health and Social Care Matt Hancock sent letters Friday on Brexit preparations for medicines supplies, offering details that the pharmaceutical industry group said need to be fleshed out further in the lead up to March 2019. In the event of a no deal scenario, the revised cross-Government planning assumptions show that there will be significantly reduced access across the short straits crossings into Dover and Folkestone for up to six mon...
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    Generic and Branded Industry Groups Spar Over EU SPC Waiver Proposal

    The European Parliament’s International Trade Committee (INTA) on Monday voted to adopt a draft opinion supporting changes to an amendment that would allow for manufacturing waivers to supplementary protection certificates (SPCs).   In the EU, SPCs extend the 20-year patent protection period for medicines by adding up to five additional years of market exclusivity to approved drugs and biologics. The additional exclusivity period is meant to compensate for the lapse be...
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    FDA Lists 205 Molecular Targets for Pediatric Cancer Research

     To help with anti-cancer drug development, the US Food and Drug Administration (FDA) has developed two new lists of molecular targets to guide submissions for pediatric study plans.   The two lists, posted Tuesday by FDA’s Oncology Center of Excellence, are aimed at fostering the development of new oncology drugs or biologics for pediatric populations. They also fulfill a commitment the agency made under the FDA Reauthorization Act of 2017 (FDARA).   One list po...
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    EMA Sartan Investigation Flags Aurobindo Pharma, Raises Zhejiang Huahai Oversight

    The European Medicines Agency (EMA) announced Monday low levels of a probable human carcinogen have been detected in a third sartan made the second India-based company—Aurobindo Pharma—to have been linked to the international valsartan scandal.   The notice follows on the heels of the EMA’s decision to extend its review to include medicines containing an additional four sartans, with the one impacted by the suspension of Aurobindo Pharma’s European certificate of s...
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    CDRH Drafts New Framework to Create a Pediatric Device Safety Network

    A draft framework is in the works at the US Food and Drug Administration (FDA) to create an innovative safety net for pediatric medical devices, Vasum Peiris, Chief Medical Officer for pediatrics and special populations at the Center for Devices and Radiological Health (CDRH), told Focus . The new framework is “centered around the fundamental issue of safety for children,” Peiris said, posing the question “where can we actually innovate safely?” Pediatric academic medic...
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    EMA to Raise MAH and Applicant Fees by 1.7% in April

    As part of the European Medicines Agency’s (EMA) alignment with the inflation rate, the agency announced on Tuesday that general, non-pharmacovigilance for applicants and marketing authorization holders are increasing by 1.7% on 1 April 2018. “All applications received by 31 March will be charged the current fee and reduction rates. Applications received after that date will be charged the adjusted fees,” EMA said. “For scientific advice and protocol assistance, the cut...
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    FDA Closes Loophole Companies Used to Skirt Pediatric Study Requirements

    The US Food and Drug Administration (FDA) on Tuesday released draft guidance indicating that it no longer intends to grant orphan drug designation to drugs for pediatric subpopulations of common diseases except for under certain conditions. Those conditions are if the use of the drug in the pediatric subpopulation are for a valid orphan subset, meaning "that use of the drug in a subset of persons with a non-rare disease or condition may be appropriate but use of th...