Regulatory Update – April 2019

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Applying for a Certificate of Pharmaceutical Product in a no deal scenario

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CDER: Assessing the Structural and Pharmacological Similarity of Newly Identified Drugs of Abuse to Controlled Substances Using Public Health Assessment

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WHO: Global Strategy on Digital Health 2020-2024

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The FDA Warns Against Use of Previously Owned Test Strips or Test Strips Not Authorized for Sale in the United States: FDA Safety Communication

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China Adds 30 Drugs to Fast Track for Products Approved Overseas

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The FDA Recommends Only Using Cleared or Approved Medical Devices to Help Assess or Diagnose a Head Injury, Including Concussion: FDA Safety Communication

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Adaptation of the Guidance document Orphan Drug HMV4

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Denmark: Medical devices and application for exemption

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FDA: Reclassification of certain Device Accessories to Class I

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 FDA: Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use

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European Commission Says Majority of Drugs, Devices Compliant Ahead of Postponed Brexit

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MDCG 2019-4 Timelines for registration of device data elements in EUDAMED

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 Health Canada – Release of ICH E17 Multi-Regional Clinical Trials

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 FDA takes action to protect women’s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices

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CDSCO: Clinical trial applications under new rule

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CDSCO Again Calls for FDC Manufacturers to File Study Protocols or Data

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TGA:  Fluoroquinolone antibiotics and risk of aortic aneurysm/dissection

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European Parliament Passes SPC Waiver in Landslide Vote

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Health Canada’s Evolving Approach to Leveraging Real World Evidence (RWE) for Drug Regulatory Decisions

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MedTech Europe Warns Over ‘Untenable’ Transition to EU MDR/IVDR

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US FDA: Bispecific Antibody Development Programs (draft guidance)

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FDA: Technical Performance Assessment 2 of Quantitative Imaging in Device 3 Premarket Submissions (draft guidance)

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DoP defers implementation of barcode at primary packs for all medicines procured under public procurement to April 1, 2020

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All medical devices sold in India to be CDSCO certified: What is Means

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Regulator orders antibiotic drug makers to carry safety warnings

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China Starts Clampdown on Unregistered Devices, Threatens Severe Punishments (report in Chinese)

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US FDA: Compliance Policy for Combination Product Post Marketing Safety Reporting

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US FDA: Surgical Staplers and Staples for Internal Use – Labeling Recommendations (draft guidance)

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France’s ANSM Issues Warning About NSAIDs Following Safety Review (report in French)
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US FDA Finalizes Guidance on Non-Clinical Bench Performance Test Reports for Device Submissions

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Swiss MedTech:   Recommendation to all Swiss manufacturers of medical devices

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US FDA:  Unique Device Identification: Convenience Kits

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