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    Asia Regulatory Roundup: Philippines to Take ‘Drastic’ Actions to Wipe out Backlog of Applications

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   Philippines to Take ‘Drastic’ Actions to Wipe out Backlog of Applications   The Philippines Food and Drug Administration (FDA) has committed to “drastic” actions to deal with its backlog of applications. Agency chief Nela Charade Puno plans to clear the backlog by waving through applications that have been pending for six months or more and then setting up a system t...
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    EU Regulatory Roundup: Swissmedic Overhauls Medical Device Certification Process to Avert Resourcing Crisis

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.   Facing Cyber Threats, EMA Seeks IT Security Experts to Review Data Policies   The European Medicines Agency (EMA) is looking for IT security experts who can help ensure its data are safe and properly managed. Officials hope to create a list of experts they can turn to for periodic assistance with reviewing data security policies and other mechanisms intended to stop b...
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    Asia Regulatory Roundup: Shanghai FDA Expands Medical Device Registration Pilot

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   Drug Industry Calls for TGA to Apply Efficacy Claimers to Prescription Medicines   The Therapeutic Goods Administration (TGA) is under pressure to apply its proposed efficacy claimers to all medicines that undergo pre-market assessments of their effectiveness. TGA proposed to allow manufacturers to use the claimers on some types of non-prescription drugs, but groups ...
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    EU Regulatory Roundup: Brexit Forces EMA to Halt Product Information Improvement Plan

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.   Brexit Forces EMA to Halt Product Information Improvement Plan   The European Medicines Agency (EMA) has hit pause on plans to improve product information after assessing the capacity constraints imposed by Brexit. EMA had hoped to spend the next two years implementing the plan, but will now hold off on starting most of the work until at least 2020.   European o...
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    Asia Regulatory Roundup: Australia Excludes Certain Cells, Tissues and Organs From Some Regulatory Oversight

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news.   Australia Excludes Certain Cells, Tissues and Organs From Some Regulatory Oversight   The Therapeutic Goods Administration (TGA) of Australia has exempted some types of cell, tissue and organ from its regulatory framework. TGA’s actions affect certain autologous human cell and tissue (HCT) products, solid organs and other materials that could be classed as biologicals.   ...
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    EU Regulatory Roundup: Ireland Joins Benelux-Centered Drug Price Negotiating Bloc

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.   Ireland Joins Benelux-Centered Drug Price Negotiating Bloc   Ireland has joined a drug price negotiating alliance set up by Belgium and the Netherlands. Bringing Ireland into the BeNeLuxA Initiative on Pharmaceutical Policy swells the population it represents by 5 million, potentially strengthening its position in talks with drug manufacturers.   Belgium and the ...
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    Asia Regulatory Roundup: TGA Extends Drug Shortage Reporting Deadlines Following Industry Feedback

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Extends Drug Shortage Reporting Deadlines Following Industry Feedback   The Therapeutic Goods Administration (TGA) of Australia has revised its planned policy on managing drug shortages in response to feedback from the industry. Manufacturers pushed back against the reporting timelines and other measures proposed by TGA, leading the agency to revise its position ...
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    EU Regulatory Roundup: EU Parliament Think Tank Finds Flaws With Commission's HTA Agenda

    Welcome to our EU Regulatory Roundup, our weekly overview of the top regulatory news in Europe.   Parliament Think Tank Finds Flaws With Commission’s HTA Agenda   The think tank of the European Parliament has found fault with preparations to increase cooperation among health technology assessment (HTA) bodies. The group found an impact assessment from the European Commission failed to present a convincing range of options for how to address the issues created by ...
  • Asia Regulatory Roundup: CDSCO Calls Top Pharma Firms to Meet on Track-and-Trace

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   CDSCO Calls Top Pharma Firms to Meeting on Track-and-Trace Implementation   The Central Drugs Standard Control Organization (CDSCO) has called Novartis, Pfizer and other major drugmakers to a meeting about a planned trial of a track-and-trace system. CDSCO is holding the meeting to discuss implementation of the Drugs Technical Advisory Board’s (DTAB) recommendation t...
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    European Regulatory Roundup: EMA to Open Secure Portal for Orphan Drug Designations

    Welcome to our EU Regulatory Roundup, our weekly overview of the top regulatory news in Europe.   EMA to Open Secure Portal for Orphan Drug Designation Filings, Management   The European Medicines Agency (EMA) is launching an online portal for orphan drug designations next week. EMA wants sponsors to start using the portal from 19 June in anticipation of it becoming mandatory three months from now.   Once live, the portal will provide sponsors with a new way ...
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    Asia Regulatory Roundup: India Designates Five Medical Device Testing Labs

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   India Designates 5 Sites as Central Medical Device Testing Laboratories   India has picked five sites to serve as central medical device testing laboratories. The facilities will test and evaluate medical devices to support the implementation of legislation that came into force at the start of the year.   Officials have chosen the National Institute of Biological...
  • EU Regulatory Roundup: Scottish Government Dismisses Talk of Compulsory Licensing of Roche Cancer Drug

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.   Scottish Government Dismisses Talk of Compulsory Licensing of Roche Cancer Drug   The Scottish government has dismissed the possibility of using compulsory licensing to get a copy of Roche’s breast cancer drug Perjeta to patients. A politician floated the idea of enacting a Crown use licence to bypass the pricing impasse that is stopping HER2-positive secondary breast...