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    Making Sense of FAERS: Researchers Suggest Fixes to FDA's Adverse Event Database

    A team of researchers from Novartis, Oracle Health Sciences and the University of California, San Francisco say the US Food and Drug Administration's (FDA) adverse drug reaction database could be improved by grouping drugs by their chemical structure and automating certain reporting functions. In a paper appearing in eLife earlier this month, the researchers say such changes could help address several major challenges to interpreting data in FDA's adverse event reporti...
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    Asia Regulatory Roundup: China’s Supreme Court Clarifies Legal Scope to Punish Trial Data Fraudsters (22 August 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Fixes Price of Orthopedic Knee Implants, Tells Manufacturers to Maintain Supply India has capped the price of orthopedic knee implants. The imposition of ceiling prices continues the National Pharmaceutical Pricing Authority’s (NPPA) push to control the cost of medical devices sold in India. Months after setting limits on the prices of coronary stents, NPPA has ...
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    European Regulatory Roundup: EMA Revises Pharmacovigilance Guideline After Danish Agency Spots 'Big Problem' (10 August 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Revises Pharmacovigilance Guideline After Danish Regulators Spot 'Big Problem' The European Medicines Agency (EMA) has revised its good pharmacovigilance practice (GVP) guideline after Danish regulators flagged up a “big problem” with a draft version. EMA's change mitigates the risk of marketing authorization holders (MAHs) and national agencies independently mergi...
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    EMA Reports Rise in Pharmacovigilance Inspections in 2016

    In a report released on Tuesday, the European Medicines Agency (EMA) said the number of pharmacovigilance inspections for centrally authorized products rose in 2016, mainly driven by an increase in routine inspections carried out under national inspection programs. Background In the EU, routine pharmacovigilance inspections are typically carried out by national regulators to check that marketing authorization holders have the personnel, systems and facilities in place t...
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    European Regulatory Roundup: EU Device Regulations Come Into Force Swissmedic Clarifies Pharmacovigilance Process (1 June 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU Regulatory news. EU Medical Device Regulations Come Into Force, Starting Multi-Year Transition Period The European Union medical device and in vitro diagnostic (IVD) regulations have come into force. The passing of the date marks the start of the phased, multi-year introductions of requirements set out in the two documents. In the immediate term, the entry of the long-gestating regu...
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    UK Pharmacovigilance Post-Brexit: Lots of Questions, Few Answers

    No one knows what UK pharmacovigilance will look like after the UK leaves the EU, and that uncertainty puts the many Qualified Persons Responsible for Pharmacovigilance (QPPVs) residing in the UK in a precarious position. According to the UK’s independent academic Drug Safety Research Unit, which organized a meeting last week on the topic of pharmacovigilance post-Brexit, "At worst, this will deal a severe blow to UK pharmacovigilance" as pharmaceutical companies "...
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    Drug Supply Chain Security: New APEC Toolkit to Aid Collaboration

    With the pharmaceutical supply chain becoming more global and complex, regulators, industry groups and academics from around the world have developed a new toolkit of resources to increase harmonization across borders to ensure the quality of drugs from manufacture through ingestion. The new toolkit, born out of a five-year collaborative project that actually took four years to complete, brings expertise from the US Pharmacopeial Convention (USP), US Food and Drug Admin...
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    Asia Regulatory Roundup: India Proposes Platform to Monitor Drug Supply Chain (21 March 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Proposes Electronic Platform to Monitor Drug Supply Chain The Indian government is proposing to create an electronic platform to monitor the drug supply chain. Officials want all manufacturers, distributors and pharmacies to register on the platform and upload details of batches they supply and receive in an attempt to raise drug standards in India. India’s Mini...
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    Pharma Inspection Co-operation Scheme Criticizes Plan to Lower GMP Requirements for ATMPs

    The regulatory group known as the Pharmaceutical Inspection Co-operation Scheme (PIC/S) said in a letter released this week that it is “unanimously concerned” about the public health and safety impact of a new European Commission guideline that would lower good manufacturing practice (GMP) requirements for advanced therapy medicinal products (ATMPs). "By lowering the GMP requirements for ATMPs, the European Commission is not only exposing patients to an increased risk t...
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    ICH Offers Reflection Paper on Good Clinical Practice Revisions

    The International Council for Harmonisation (ICH) on Thursday opened for comment a new reflection paper on Good Clinical Practice (GCP), part of a plan to modernize ICH guidelines on clinical trial design, planning, management and conduct. The scope of the revisions includes the current E8 General Considerations for Clinical Trials and further revision to the E6 Guideline for Good Clinical Practice , which is already undergoing modernization with the recent de...
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    FDA Warns Spanish API Maker for GMP Violations

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Spanish active pharmaceutical ingredient (API) maker Interquim, S.A. for several good manufacturing practices (GMP) violations uncovered during an inspection of the company's Barcelona facility last May. In a warning letter, FDA cites Interquim for three issues related to its cleaning procedures, deteriorated equipment surfaces and stability testing data. According to FDA, Interquim d...
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    ICH Looks to Revamp GCP Guidelines, Adds New Members

    Members of the International Council for Harmonisation (ICH) agreed on several moves that would revamp the organization's good clinical practice (GCP) guidelines during a meeting in Osaka, Japan last week. Following discussions, ICH said it plans to conduct a broad review of its guidelines related to GCP and clinical trial design, beginning with a reflection paper expected in early 2017. "This will include updating current guidance on interventional trials and expand on...