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  • Regulatory NewsRegulatory News

    Pharmacovigilance and QPPV: Post-transition guidance from MHRA

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) this week issued guidance detailing post-transition pharmacovigilance procedures and requirements for having a qualified person responsible for pharmacovigilance (QPPV) and a pharmacovigilance system master file (PSMF) for UK authorized products.   Pharmacovigilance   MHRA says it “will retain responsibility for pharmacovigilance across the UK from 1 January 2021,” but notes that there will be di...
  • Regulatory NewsRegulatory News

    FDA issues pandemic inspections FAQ guidance

    The US Food and Drug Administration (FDA) on Wednesday issued an immediately effective frequently asked questions guidance  explaining its approach to inspections and manufacturing and supply chain changes during the coronavirus disease (COVID-19) pandemic.   Inspections   For the time being, FDA says it is still following the approach to resuming domestic inspections it laid out last month and will continue to postpone non-mission-critical foreign pre-approval an...
  • Regulatory NewsRegulatory News

    FDA looks to resume domestic inspections this month

    Months after halting most inspections amid the coronavirus disease (COVID-19) pandemic, the US Food and Drug Administration (FDA) on Friday said it plans to resume on-site domestic inspections beginning the week of 20 July 2020.   As a safety measure, FDA will pre-announce all inspections, save for retail tobacco inspections, for the foreseeable future.   The announcement comes nearly two months after the agency said it will implement a phased approach to restartin...
  • RoundupsRoundups

    Asia Regulatory Roundup: TGA Seeks Feedback on Planned Changes to Medical Device Rules

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Seeks Feedback on Planned Changes to Medical Device Rules   Australia’s Therapeutic Goods Administration (TGA) is seeking feedback on two sets of medical device proposals. The proposals address essential principles for safety and performance and the regulatory requirements for medical device systems and procedure packs.   Both documents grew out of the Austra...
  • Regulatory NewsRegulatory News

    Grassley Calls for More Unannounced Foreign Drug Inspections From FDA

    As the US Food and Drug Administration (FDA) explores plans to lower the cost of pharmaceuticals with imports from Canada and elsewhere, Sen. Chuck Grassley (R-IA) is calling on the agency to perform more unannounced inspections of foreign facilities. Thanks to recent media coverage (on  China and tainted blood pressure medicines  and another article on  generic drug manufacturing ) as well as a controversial new book on the US reliance on foreign-made generic medicin...
  • Regulatory NewsRegulatory News

    FDA Drafts Guidance on Inspections of Medical Device Establishments

    The US Food and Drug Administration (FDA) issued draft guidance on Thursday to implement uniform processes and standards for FDA inspections of domestic and foreign medical device establishments. FDA has updated processes and standards for uniformity within and across inspections other than for-cause and to establish a standard timeframe for such inspections of device establishments. The uniformity in FDA investigators’ approaches to these inspections “may inform firms’...
  • Regulatory NewsRegulatory News

    MHRA Explains No-Deal Brexit Pharmacovigilance Requirements

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday issued guidance for drugmakers on how to comply with pharmacovigilance requirements in the event the UK leaves the EU without a deal later this month.   The guidance comes the same day as the UK Parliament voted down a revised version of the Brexit deal the UK and EU negotiated last November.   After the vote, UK Prime Minister Theresa May reiterated her commitment to leaving the EU with...
  • Regulatory NewsRegulatory News

    Experts Question FDA Proposal to Conduct Manufacturing Inspections for De Novo Reviews

    Industry experts raised questions around the US Food and Drug Administration (FDA) recent proposal that would allow FDA to inspect manufacturing facilities prior to granting de novo classification requests. The proposal is part of the 76-page proposed rule FDA’s Center for Devices and Radiological Health (CDRH) set forth last December. The proposed rule addresses the lack of de novo-specific regulation that puts the program at a disadvantage compared to the traditiona...
  • Regulatory NewsRegulatory News

    FDA Warns Two Drugmakers for GMP Violations

    The US Food and Drug Administration (FDA) recently warned two drugmakers, Phoenix-based Vasco Rx and Commerce, CA-based Samson Pharmaceuticals, for good manufacturing practice violations at their facilities.   Vasco Rx   FDA’s warning letter to Vasco Rx comes after the agency inspected the company’s manufacturing site in March and April 2018.   At the end of the inspection in April, Vasco Rx stopped production and later voluntarily recalled all sterile drugs pr...
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    CDRH Drafts Method to Provide Feedback on FDA Form 483 Citations

    The Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) issued draft guidance Friday to standardize a mechanism for a medical device establishment to request nonbinding feedback on actions such establishments propose to take to address an FDA Form 483. The draft standardized method has five parts. These relate to submitting a timely request—as defined by the agency—the statutory eligibility criteria, the device establishment’s ...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    CDRH’s Case for Quality Pilot Gains Momentum

    The pilot program led by the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) aimed at manufacturing and product quality has gained momentum this year, with dozens of waived post-approval and risk-based inspections among participating firms.   The pilot program is collectively run by CDRH and the FDA-funded public-private partnership Medical Device Innovation Consortium (MDIC) and the CMMI Institute under CDRH’s 2014 Case for Qua...