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    Asia Regulatory Roundup: CFDA Offers New Drug, Device Draft Guidance (16 May 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Shares Flurry of Proposals to Encourage Drug, Medical Device Innovation The China Food and Drug Administration (CFDA) has released four draft documents intended to encourage innovation in the drug and medical device industries. CFDA’s proposals aim to cut the time it takes to set up a clinical study, accelerate the approval process, overhaul the patent system and...
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    FDA Launches New ORA Structure to Align Inspections With Expertise

    The US Food and Drug Administration (FDA) on Monday released details on the structure of its newly realigned Office of Regulatory Affairs (ORA). The move, part of FDA's program alignment , is aimed at more closely aligning the agency's inspection efforts with the various products it regulates. "Specializing by FDA-regulated product type more closely mirrors the organizational model of FDA's centers and the industries we regulate," FDA writes. Under the agency's previo...
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    European Regulatory Roundup: EMA Issues Increasing Number of GMP Non-Compliance Statements in India (11 May 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EU GMP Inspectors Issued Non-Compliance Statements to 11% of Indian Sites Visited in 2016 Authorities in the European Economic Area (EEA) issued non-compliance statements to 11% of the Indian drug manufacturing plants they inspected in 2016. The rate of non-compliance is far higher than the 1% recorded globally in 2016 and the 4-6% level seen in India in the three prev...
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    FDA Official Highlights Foreign Supply Chain Challenges

    Drugmakers should be mindful of the risks involved with relying on foreign manufacturers as part of their supply chain, said Thomas Cosgrove, director of the US Food and Drug Administration's (FDA) Office of Manufacturing Quality within the Center for Drug Evaluation and Research. Speaking at the Food and Drug Law Institute's annual conference on Friday, Cosgrove detailed some of the biggest challenges drugmakers face when contracting with foreign manufacturers, which fi...
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    House Committee Considers Four Device Bills to Add to User Fee Reauthorization

    The House Energy & Commerce Committee on Tuesday discussed four bipartisan bills likely to be added to the user fee reauthorization package that aim to improve the US Food and Drug Administration’s (FDA) regulation of medical devices and inspections of device manufacturing sites. The committee discussed the bills with various experts and Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, who offered no opposition to any of the measure...
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    FDA Warns Teva API Plant in China

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 10 April to Teva for deficiencies related to an active pharmaceutical ingredient (API) manufacturing site in Hangzhou, China. The letter, first disclosed in an SEC filing in which the company said it would respond by 1 May, includes two observations for failing to establish written procedures to monitor the progress and control the performance of processing steps that may cause v...
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    MHRA Investigates GMP Deficiency Trends From 2016

    The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) on Tuesday released a new report on the trends seen from inspecting pharmaceutical manufacturing plants and evaluating their good manufacturing practices (GMPs) in 2016. Compared to 2015, MHRA conducted 21 more total GMP inspections in 2016, and three more foreign inspections. But like in 2015, the most cited deficiency for 2016 was related to companies’ quality systems. Sterility assurance, producti...
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    Asia Regulatory Roundup: India Looks to Reform Drug Pricing Legislation (18 April 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Forms Leadership Group to Reform Drug Pricing Legislation, NPPA India has convened a committee to consider reforms to drug pricing legislation and the agency that enforces the rules. Officials at the Department of Pharmaceuticals took the step in response to feedback from regulators and industry about the shortcomings of the existing pricing legislation and mech...
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    AdvaMed CEO Confident of Device Tax Repeal This Year

    The Advanced Medical Technology Association's (AdvaMed) President and CEO Scott Whitaker said Tuesday he's confident that the medical device tax introduced under the Affordable Care Act will be repealed this year. Whitaker made the remarks during a call with reporters on Tuesday, where he also discussed potential changes to the US Food and Drug Administration's (FDA) inspection program for devices. Device Tax Repeal Despite the stalling of the Obamacare replacement b...
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    FDA Office of Regulatory Affairs Realignment to Begin in May

    The US Food and Drug Administration's (FDA) Office of Regulatory Affairs (ORA), which carries out the agency's inspection program, will officially begin a major overhaul in the coming weeks, according to FDA's Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren. Shuren made the announcement to members of the House Energy & Commerce Committee on Tuesday at a hearing on the Medical Device User Fee Amendments , which must be reauthorized by 30 Septemb...
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    Asia Regulatory Roundup: TGA Increases Inspections Following Adoption of Risk-Based Approach (7 March 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Steps up Initial GMP Inspections After Adopting Risk-Based Approach The Therapeutic Goods Administration (TGA) of Australia has increased initial inspections of drug manufacturing plants at home and overseas. TGA reported double-digit increases in the number of initial inspections of local and foreign firms in the back half of last year following the introduction ...
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    US and EU Forge Landmark Agreement to Mutually Recognize Drug Manufacturing Inspections

    After wrangling over the details of trade secrets and inspection differences, the US and EU on Thursday finally announced they have agreed to mutually recognize one another’s pharmaceutical manufacturing inspections – a deal likely to lead to less duplicative inspections and lower costs on both sides of the Atlantic. Originally part of the Transatlantic Trade and Investment Partnership discussions under President Barack Obama , the agreement will allow US and EU regulat...