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    EU Regulatory Roundup: Rising Complexity Drives Sharp Fall in MHRA Pharmacovigilance Inspections

    Welcome to our European   Regulatory Roundup, our weekly overview of the top EU regulatory news.   EMA Advises Novartis on use of eSource Direct Data Capture in Clinical Trials   The European Medicines Agency (EMA) has outlined its views on eSource direct capture of clinical trial data in response to questions from Novartis. EMA sees no theoretical obstacles to the use of the technology in a way that complies with good clinical practices (GCPs), but thinks sponso...
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    Asia Regulatory Roundup: China Targets Data Integrity In Checklist for Inspectors of Medical Device Trials

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Creates Guidance to Help Surgical Mesh Manufacturers Reclassify Devices   Australia’s Therapeutic Goods Administration (TGA) has created guidance to help sponsors of surgical mesh devices manage a change in their regulatory status. TGA published the guidance days before reclassifying the devices as high-risk Class III products.   Surgical mesh devices have hi...
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    EU Regulatory Roundup: UK and EU Agree to Explore Regulatory Cooperation After Brexit

    Welcome to our European   Regulatory Roundup, our weekly overview of the top EU regulatory news.   UK and EU Agree to ‘Explore the Possibility’ of MHRA-EMA Cooperation After Brexit   The EU has agreed to consider continuing to cooperate with the United Kingdom on drug and device regulations after Brexit. UK officials secured the commitment from the EU as part of a text sketching out the future relationship between the two regions.   Under pressure from compan...
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    Asia Regulatory Roundup: Indian Court Rejects Abbott’s Plea to Stop Probe into Alleged Diabetes Cartel

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Posts Guidance on How to Manage and Communicate Drug Shortages   Australia’s Therapeutic Goods Administration (TGA) has posted guidance on the communication and management of drug shortages. The publication of the document comes five weeks before Australia makes the reporting of medicines shortages mandatory.   TGA proposed moving to a mandatory model in Apri...
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    Asia Regulatory Roundup: CDSCO Reopens Clinical Trial Rules for Comment

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   CDSCO Reopens Clinical Trial Rules for Comment After Supreme Court Order   The Central Drugs Standard Control Organization (CDSCO) is accepting further feedback on its clinical trial rules. CDSCO closed comments on the draft earlier this year, only for the Supreme Court to tell it to give people another chance to share their views.   India’s Supreme Court made th...
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    EU Regulatory Roundup: EMA Seeks Feedback on Using Registries for Regulatory Purposes

    Welcome to our European   Regulatory Roundup, our weekly overview of the top EU regulatory news.   EMA Seeks Feedback on the Use of Disease Registries for Regulatory Purposes   The European Medicines Agency (EMA) is seeking feedback on the use of patient disease registries for regulatory purposes. EMA dedicates most of the draft discussion paper to an overview of good registry practices and registry studies.   Data housed in registries can be useful in the re...
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    Asia Regulatory Roundup: New Zealand Adopts Major Revision to Clinical Trial Rules

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   New Zealand Adopts Major Revision to Clinical Trial Rules Following Positive Feedback   The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has revised its guideline on clinical trials. Medsafe adopted the major reworking of the earlier guideline after its draft revisions received mostly positive feedback from drug developers during a recent cons...
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    EU Regulatory Roundup: Industry Finds Fault With UK Vision for Drug Regulation After Brexit

    Welcome to our European   Regulatory Roundup, our weekly overview of the top EU regulatory news.   Industry Finds Fault With UK Vision for Drug Regulation After Brexit   British biopharma trade groups have spoken out against changes to drug regulation that could be enacted in the event of a no-deal Brexit. The trade groups found fault with proposals for how the Medicines and Healthcare products Regulatory Agency (MHRA) will handle orphan drugs, regulatory fees, ...
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    Asia Regulatory Roundup: TGA Tweaks New Advertising Code

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Tweaks New Advertising Code, Supporting Guidance Ahead of Implementation Date   Australia's Therapeutic Goods Administration (TGA) has changed its advertising code and supporting guidance after receiving feedback. The latest version gives the industry until September 2020 to add warnings about eggs, nuts and other allergens to advertisements for registered and li...
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    EU Regulatory Roundup: UK Dismisses Rumors of 20-Week Stockpile Request but Admits Extensions Are Possible

    Welcome to our European   Regulatory Roundup, our weekly overview of the top EU regulatory news.   ENVI Calls for Parliament Role in Agency Locations as EU Considers Governance Problems   The European Parliament’s health committee wants to use a review of the governance of agencies as an opportunity to ensure it plays an active role in future decisions. Members of the Committee on the Environment, Public Health and Food Safety (ENVI) put forward the ideas as a re...
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    Asia Regulatory Roundup: Gilead Warns TGA Could ‘Drastically Expand’ Use of Boxed Warnings

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   Gilead Warns TGA Guidance Could ‘ Drastically Expand’ Use of Boxed Warnings   Gilead Sciences has criticized the Therapeutic Goods Administration’s (TGA) draft guidance on boxed warnings. The biotech warned the proposal could “drastically expand” use of the safety alerts and thereby limit their effectiveness.   Australia passed a resolution covering boxed warn...
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    EU Regulatory Roundup: UK Industry Sounds Alarm Over Impact of Brexit

    Welcome to our European   Regulatory Roundup, our weekly overview of the top EU regulatory news.   UK Industry Sounds Alarm Over Impact of Brexit, Regulatory Split on Supply Chains   Leaders of the British drug manufacturing and distribution sector have warned that the government’s preparations for a no-deal Brexit are insufficient to stop disruption. The trade group heads said the industry lacks the cold-chain capacity to meet the government’s stockpiling requ...