• Regulatory NewsRegulatory News

    GVP: EMA consults on revised risk minimization module

    The European Medicines Agency (EMA) on Wednesday released draft versions of the third revision to its good pharmacovigilance practice (GVP) module XVI guideline on risk minimization measures and its second addendum to the guideline on methods for evaluating the effectiveness of risk minimization measures for public consultation.   The deadline to comment on the documents is 28 April 2021 and EMA says it expects the revised guideline and new addendum to come into effect...
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    EMA revises remote pharmacovigilance inspections guide

    The European Medicines Agency (EMA) has refreshed its points to consider document on remote pharmacovigilance inspections during a crisis, such as the current COVID-19 pandemic.   The revisions to the document are minor and mostly relate to the preparation phase ahead of a pharmacovigilance inspection when an on-site inspection would not be feasible due to a crisis.   In the revised document, EMA has replaced the term “distant/virtual” with “remote” and has expande...
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    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...
  • Feature ArticlesFeature Articles

    Designing a biologics manufacturing facility: Early planning for success

    This article reviews important steps in the manufacture of biologics. The authors provide planning steps for compliance with current good manufacturing practice (CGMP) to readiness for chemistry, manufacturing, and controls (CMC). They pose important questions manufacturers should address, from facility issues to working with a contract development manufacturing organization. They conclude that trends toward reducing the time to market put considerable stress on all aspect...
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    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...
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    FDA Warns Jubilant, Pfizer Subsidiary in India

    The US Food and Drug Administration (FDA) last week sent warning letters to Pfizer’s subsidiary Hospira and Jubilant Life Sciences over good manufacturing practice (GMP) violations at the companies’ facilities in India.   Pfizer   In its warning letter to Pfizer, FDA says that products made at its Hospira facility in Tamil Nadu, India are adulterated as a result of data integrity breaches and laboratory testing shortcomings observed during a week-long inspection la...
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    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...
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    FDA Warns Pennsylvania Drugmaker Over GMP Violations

    The US Food and Drug Administration (FDA) last month warned Vilvet Pharmaceuticals over good manufacturing practice (GMP) issues and for failing to list two of its products with the agency.   The warning letter comes after a 10-day inspection of Vilvet’s Chester Springs, PA facility in June 2018.   According to FDA, Vilvet failed to establish and follow adequate quality control practices, including failing to review batches of drugs made by a contract manufacturer....
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    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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    FDA Warns Chinese OTC Drugmaker, Florida Fertility Center

    The US Food and Drug Administration (FDA) last month sent warning letters to Chinese over-the-counter (OTC) drugmaker Hangzhou Guoguang Touring Commodity Co. and the University of Miami Reproductive and Fertility Center.   Hangzhou Guoguang   The warning letter comes after FDA placed Hangzhou Guoguang on import alert in October following an inspection of the company's Zhejiang facility over four days last April.   According to the warning letter, Hangzhou Guog...
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    Data Integrity Q&A: FDA Finalizes Guidance

    The US Food and Drug Administration (FDA) on Wednesday finalized its questions and answers guidance on complying with data integrity requirements under current good manufacturing practice (CGMP) for drugs and biologics. The guidance updates a draft version released in 2016 and has been revised to include additional information on the agency’s current thinking on data integrity to help drugmakers identify lapses and implement best practices to shore up any gaps in thei...
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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...