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    Asia Regulatory Roundup: China Strengthens Supervision of Online Drug, Device Sales (7 November 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Strengthens Supervision of Online Drug and Medical Device Sales The China Food and Drug Administration (CFDA) has moved to strengthen oversight of online sales of drugs and medical devices. CFDA outlined its plans in a notice instructing its regional outposts to step up their monitoring of the internet and make it easier for the public to alert them of illegal a...
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    Democrats Propose Wide-Ranging Bill to Lower Drug Costs

    More than a dozen House and Senate Democrats late Wednesday unveiled a host of new provisions to bring down the rising cost of pharmaceuticals, offering up many ideas that have been publicly opposed by the pharmaceutical industry. The bill, known as the Improving Access to Affordable Prescription Drugs Act , was introduced alongside a House companion , though neither is likely to gain much traction in the Republican-controlled House and Senate. However, some of the b...
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    Four Former FDA Commissioners: Drug Importation to Reduce Costs is 'Complex and Risky'

    As Congress looks to address the problem of rising prescription drug prices, four former US Food and Drug Administration (FDA) commissioners told members in an open letter from last week that importing cheaper medicines from Canada and elsewhere is "a complex and risky approach." Former commissioners Robert Califf, MD, Margaret  Hamburg, MD, Mark McClellan, MD, PhD and Andrew Von Eschenbach, MD, write that although in some shortage cases, importation of generic dru...
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    Democrats Revive Canada Drug Import Bill as Safety Questions Linger

    Sens. Bernie Sanders (D-VT) and several colleagues who previously opposed such a measure, Cory Booker (D-NJ), Bob Casey (D-PA), Martin Heinrich (D-NM), Angus King (I-ME), alongside Reps. Elijah Cummings (D-MD) and Lloyd Doggett (D-TX) on Tuesday revived legislation lingering for more than a decade to allow the importation of medicines from Canada and other countries to help lower US drug prices. Sanders called the bill "critical" on Tuesday at a press conference, saying...
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    Senators Call on HHS to Allow Canadian Drug Imports if Prices Spike

    Sens. Charles Grassley (R-IA), John McCain (R-AZ) and Amy Klobuchar (D-MN) on Tuesday sent a letter to Tom Price, the newly confirmed secretary of the Department of Health and Human Services (HHS), calling on him to fast-track the approval of prescription drugs imported from Canada in four different circumstances, including if the price of a drug increases significantly. Those circumstances are: If a drug is off patent or no longer marketed in the US by the innovato...
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    European Regulatory Roundup: EC to Let MAHs Delegate Certain Falsified Medicines Directive Tasks to Third Parties (23 June 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EC Accepts APIs Imported, but not Manufactured, After the Expiration of a Written Confirmation The European Commission (EC) has updated its question and answer document on the importation of active pharmaceutical ingredients (APIs) for use in human medicinal products. The update adds a section clarifying EC’s position on APIs manufactured while a written confirmation was in...
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    FDA Pilot Project to Test New Import Communication System

    The Food and Drug Administration (FDA) on Wednesday said it intends to conduct a pilot program to test and evaluate a new Import Trade Auxiliary Communication System (ITACS) and is seeking participants. The purpose of the pilot is to test and evaluate a new ITACS account management function with user login accounts that enable FDA to distribute “Notices of FDA Action” to users electronically via email (rather than regular mail) and enable users to download such notices....
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    Asia Regulatory Roundup: India Taxes Cancer, HIV Drug Imports (9 February 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Imposes Tax on Imports of Cancer and HIV drugs India has stopped exempting more than 70 drugs from customs duties. The ruling means companies that import any of the products or manufacture them within special economic zones will have to pay more tax, potentially giving local producers an advantage over foreign businesses. Officials at the Central Board of Excise and...
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    Importers of FDA-Regulated Products Prepare for February Shift to Automated System

    In partnership with Customs and Border Protection (CBP) and 46 other government agencies, the Food and Drug Administration (FDA) has developed and is quickly transitioning to a new portal through which industry can electronically submit all data required by government agencies for international trade. As of 28 February, 2016, all importers and brokers of FDA-regulated products will have to submit entry data through the new Automated Commercial Environment (ACE). And by t...
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    FDA Still Reviewing Arizona, Texas Claims on Importing Execution Drugs

    Arizona and Texas continue to battle with the US Food and Drug Administration (FDA) over the legality of importing drugs used in executions, more than two years after a Court of Appeals said the agency cannot allow the imports. Background As Focus  has reported since 2012, FDA has a complicated history with execution drugs, particularly sodium thiopental, which can be used alone or as part of a cocktail intended to execute inmates on Death Row. Issues with the drug...
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    Three Asian Companies Banned From Sending Imports to the US by FDA

    China-based Jinan Jinda Pharmaceutical Chemistry Co., Zhejiang Qianfei Enterprise Co. and Hong Kong-based Chan Yat Hing Medicine Factory were added to the US Food and Drug Administration’s (FDA) import alert list over the last two weeks, effectively banning the companies from shipping products to the US. FDA has now added 21 new companies to its import alert list in 2015, with companies listed from Canada (1), China (4), Czech Republic (1), Denmark (1), Hong Kong (1), In...
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    Senators Call on FDA to Allow Certain Canadian Drug Imports

    The US Food and Drug Administration (FDA) should allow the importation of pharmaceutical products from Canada if they meet certain stipulations, Sens. Chuck Grassley (R-IA) and John McCain (R-AZ) wrote in a letter to Health and Human Services (HHS) Secretary Sylvia Burwell. The senators call on FDA to “immediately” certify the importation of prescription drugs if they are off patent and are no longer marketed by the drug developer, if there are “significant and unexplain...