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    EU Regulatory Roundup: Commission Outlines How EU Data Protection Rules Affect Clinical Trial Sponsors

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   Commission Outlines How EU Data Protection Rules Affect Clinical Trial Sponsors   The European Commission has published a document detailing the interplay between clinical trial rules and the General Data Protection Regulation (GDPR). The document sets out the data protection requirements of the incoming Clinical Trials Regulation (CTR) and how they interact with GD...
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    Asia Regulatory Roundup: Australia and New Zealand Defer Decision on Potential Breast Implant Ban

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   Australia and New Zealand Defer Decision on Potential Breast Implant Ban   Regulatory agencies in Australia and New Zealand have held off on deciding whether to ban certain breast implants over a link to a form of cancer. The agencies clarified their positions after their peers in Canada and France prohibited the sale of Allergan’s Biocell.   Authorities in Canad...
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    EU Regulatory Roundup: Swissmedic Updates Guidance on Orphan Drugs, Pediatric Investigation Plans

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   Swissmedic Updates Guidance on Orphan Drugs, Pediatric Investigation Plans   The Swiss Agency for Therapeutic Products (Swissmedic) has updated its guidance on orphan drugs and pediatric investigation plans (PIPs). The revisions address topics, including orphan drug fees and the documentation to supply in support of European and American PIPs.   Swissmedic’s cha...
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    Asia Regulatory Roundup: China Adds 30 Drugs to Fast Track for Products Approved Overseas

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Reports Jump in Timely Completions of Overseas GMP Inspections   Australia’s Therapeutic Goods Administration (TGA) has improved the on-time rate of its overseas inspection operation. TGA performed 78% of inspections on time over the second half of last year, up from 53% over the corresponding period of 2017.   The agency aims to perform initial good manufact...
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    Asia Regulatory Roundup: India Drops Interim Compensation Requirements From Proposed Clinical Trial Rules

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Drops Interim Compensation Requirements From Proposed Clinical Trial Rules India has dropped interim compensation requirements from its clinical trial rules following feedback from industry. The previous draft of the rules required sponsors to make quick payments to research subjects if the ethics committee deemed a clinical trial to have caused death or permanent d...
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    EU Regulatory Roundup: EU Drafts Guidance on Assessing the Benefits and Risks of Phthalates

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   EU Drafts Guidance on Assessing the Benefits and Risks of Phthalates   The European Commission has published draft guidelines on assessing the risk and benefits of using phthalates in medical devices. Officials published the guidelines to help manufacturers comply with restrictions on the use of phthalates in the incoming Medical Device Regulation.   Phthalates ...
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    Asia Regulatory Roundup: TGA Finds Faults During Pharmacovigilance Inspections

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Finds Major Faults During Every Pharmacovigilance Inspection in First Year of Scheme   Australia’s Therapeutic Goods Administration (TGA) found at least four major deficiencies in every pharmacovigilance inspection it performed last year. The prevalence of major findings suggests the industry is still getting used to the requirements.   TGA began its pharmaco...
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    EU Regulatory Roundup: Denmark Teams With WHO to Help Build Regulatory Capacity in Poorer Countries

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   UK Government Holds off Backlash Against ‘Extraordinary Power Grab’ on Drug Shortages   The United Kingdom government has resisted an attempt to revoke changes to the handling of drug shortages. An opposition politician called the serious shortage protocol reforms an “extraordinary power grab” but was unable to rally enough support in parliament to get the changes r...
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    Asia Regulatory Roundup: Singapore’s HSA Apologizes After Vendor Stores Data in Vulnerable Repository

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   Singapore’s HSA Apologizes After Vendor Stores Data in Vulnerable Repository   Singapore’s Health Sciences Authority (HSA) has apologized to blood donors after a vendor stored their information in a vulnerable database. HSA learned the database lacked adequate safeguards from a cybersecurity expert and does not think other unauthorized people accessed the information...
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    EU Regulatory Roundup: UK Industry and Lords Criticize No-Deal Preparations

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   UK Industry and Lords Criticize No-Deal Preparations as Potential Hard Split Nears   Members of the House of Lords have strongly criticized the United Kingdom government’s attempts to lessen the effect of a no-deal Brexit on the biopharma industry. Citing feedback from industry and the government’s own impact assessment, the Lords warned the mitigating actions riske...
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    Asia Regulatory Roundup: India Expands Cost Controls for Cancer Drugs

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   India Expands Cost Controls for Cancer Drugs, Cutting Prices by up to 87%   India’s National Pharmaceutical Pricing Authority (NPPA) has brought 390 brands of non-scheduled cancer medicines under tougher price controls. The changes impose a 30% trade margin cap on the products, resulting in price cuts of up to 87% on certain products.   NPPA outlined plans to cha...
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    EU Regulatory Roundup: UK Talks Up Prospect of No-Deal Brexit Accelerating Access to New Medicines

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   UK Talks Up Prospect of No-Deal Brexit Accelerating Access to New Medicines   The British health minister has talked up the prospect of a no-deal Brexit accelerating access to new medicines.   After receiving clear feedback from industry about the importance of harmonization, the government largely stopped talking about adopting a divergent, lighter medicine reg...