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    Updated: US-EU Agreement on GMP Inspections Adds 5 More Member States

    The US Food and Drug Administration (FDA) earlier this month confirmed the capabilities of Belgium, Denmark, Finland, Estonia and Latvia so that FDA can now rely on the inspections in each of those countries, reducing the need for duplicative work.   A total of 19 member states in the EU are now qualified by FDA as having the capability, capacity and procedures in place to carry out good manufacturing practice (GMP) inspections at a level equivalent to the US. However,...
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    FDA Approves 15th Biosimilar, First for Rituximab

    The US Food and Drug Administration (FDA) on Wednesday approved Celltrion and Teva’s Truxima (rituximab-abbs) as the first biosimilar to Rituxan (rituximab) for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combination with chemotherapy.  This is FDA’s 15 th biosimilar approval overall, the third in the last month and the first for rituximab in the US. Only six biosimilars are currently on the...
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    Chinese Heparin Manufacturer Receives Statement of GMP Noncompliance

    Sichuan, China-based Yibin Lihao Bio-technology Co. earlier this month received a statement of noncompliance with good manufacturing practices (GMP) from the Italian Medicines Agency. The statement followed an inspection at the firm’s crude heparin manufacturing site on 31 October 2018. The extraction of substance from animal sources, certain physical processing and packaging steps and biological testing were found to be noncompliant. The inspection identified 24 GMP...
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    FDA Spotlights Recent Spike in Drug Shortages

    The US Food and Drug Administration (FDA) is not just seeing an increase in drug shortages but also a spike in the intensity and duration of shortages, according to agency presentations at an FDA/Duke Margolis Center for Health Policy event on Tuesday. Matthew Rosenberg, an economics staffer at FDA, looked at drug shortages in terms of occurrence, duration, intensity and public health impact. Combining data from FDA archives and IQVIA national sales database, Rosenbe...
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    EMA Drafts Reflection Paper on the Qualification of Non-Genotoxic Impurities

    The European Medicines Agency (EMA) last week unveiled a new draft reflection paper on the safety evaluation of non-genotoxic impurities (NGI) in chemically synthesized pharmaceuticals. While noting that “little guidance is available on how these impurities should be qualified,” the draft reflection paper builds off ICH quality guidelines addressing qualification of NGI – ICH Q3A and Q3B. The reflection paper includes a discussion of “how a more impurity-specific eva...
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    European Commission Revises Q&A on Safety Features for Medicinal Products

    The European Commission on Monday released a revised question and answer document regarding the implementation of the rules on the safety features for medicinal products for human use. Revisions in the document are related to two questions and answers, including one on if a pack bearing safety features is lawfully opened by, for instance, parallel traders or manufacturers replacing the leaflet, can the pack be resealed? The answer notes that in certain circumstances it ...
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    BIO Seeks Clarity on FDA’s Gene Therapy Draft Guidances

    Industry group BIO recently submitted comments on a series of new draft guidance documents on gene therapy released by the US Food and Drug Administration (FDA) in July. The six guidance documents focus on developing hemophilia, rare disease and retinal disorder gene therapies, and also include one on chemistry, manufacturing and control (CMC) information, one on long term follow-up observational studies collecting data on adverse events and one on the testing of retr...
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    EMA Preps for Better Electronic Delivery of Package Leaflets, Product Information

    Next Wednesday, the European Medicines Agency (EMA) is holding a workshop with the Heads of Medicines Agencies and European Commission to discuss the various ways to implement electronic product information (ePI) in the EU. EMA said the outcome of the workshop will serve as a basis to draft key principles for the use of ePI in the EU, which will be released for a six-month public consultation in January 2019. Currently, product information of a medicine, which includ...
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    Recon: FDA Warns of Severe Worsening of MS After Stopping Gilenya; EC Signs Off on Takeda Acquisition of Shire

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Step off our 'donut hole' deal: AARP ads take on Big Pharma lobbying ( Fierce ) US FDA Office Of New Drugs Likely To Be Headed By Deputy Director Stein ( Pink Sheet -$) FDA warns about severe worsening of multiple sclerosis after stopping the medicine Gilenya ( FDA ) Apple in Talks to Give Veterans Access to Electronic Medical Records ( WSJ -$) Walgreens, Humana...
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    EMA Warns of Impurity in Valsartan From Mylan

    The European Medicines Agency (EMA) on Monday announced the European Directorate for the Quality of Medicines and Healthcare (EDQM) has suspended the certificate of suitability to the monographs of the European Pharmacopeia (CEP) for Mylan Laboratories in Hyderabad, India. The action follows the identification of an impurity, N-nitrosodiethylamine (NDEA), in some batches of valsartan made by Mylan. The finding is just the latest in a series of NDEA and N-nitrosodimethyl...
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    EMA, Health Canada to Tighten Alliance Around Mutual GMP Inspections

    Though the European Medicines Agency (EMA) and Canada have had a mutual recognition agreement (MRA) in operation since February 2003, both sides announced Monday that they may further strengthen their ties. On Friday, the European Commission’s DG Sante, EMA and Health Canada held the first Joint Sectoral Group (JSG) on Pharmaceuticals, which is a specialized committee established under the Committee on Trade in Goods of the Comprehensive Economic and Trade Agreement (CE...
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    AdvaMed and AAMI Weigh FDA Draft Guidance on Voluntary Consensus Standards

    Medical device industry group AdvaMed and the Association for the Advancement of Medical Instrumentation (AAMI) are seeking additional information from the US Food and Drug Administration (FDA) on draft guidance related to the recognition and withdrawal of voluntary consensus standards. The 8-page draft from September describes the procedures that FDA follows and the actions the agency may take during its review and evaluation of requests for standards recognition or ...