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Manufacturers China Pharmaceutical Industry

Morgan Lewis

China Boosts Regulatory Framework for Local Pharmaceutical Manufacturing

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In recent years, China has introduced significant changes to its Drug Administration Law and corresponding legislation, including the nationwide Market Authorization Holder (MAH) system. These reforms aim to boost foreign...more

Akin Gump Strauss Hauer & Feld LLP

America’s Pharmaceutical Supply Chain: An Overview of the Policy Landscape and Potential Path Forward

For several years, policy-makers and commentators have expressed concern about the resilience of the United States’ pharmaceutical supply chain. Current U.S.-based manufacturing capabilities have been at the forefront of...more

K&L Gates LLP

Five Things to Know About the Changes to China's Medical Device Regulation

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On 18 March 2021, the State Council of China announced certain amendments (the 2021 Amendment) to the Regulation on the Supervision and Administration of Medical Devices (the Medical Device Regulation). The 2021 Amendment...more

Husch Blackwell LLP

White House Issues Final Report On Supply Chain Risks And Considers Section 232 Investigation Into Imports Of Neodymium Magnets

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President Biden issued Executive Order (“EO”) 14017 titled “America’s Supply Chains” on February 24, 2021, ordering 100-day and 1-year reviews of certain critical supply chains. On June 8, 2021, a final report was published,...more

WilmerHale

Biden Administration Announces Steps to Strengthen Critical Supply Chains

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On June 8, the Biden Administration released reports on the supply chain reviews directed under Executive Order (E.O.) 14017, “America’s Supply Chains,” detailing key findings and next steps to strengthen the resilience of...more

Hogan Lovells

The TGA and the Iron Mask

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In 2020, heightened demand for health care resulted in an influx of therapeutic goods being included on the Australian Register of Therapeutic Goods (ARTG). A large portion of these goods are manufactured in China however,...more

Hogan Lovells

FDA postpones foreign inspections amid growing concerns over coronavirus (COVID-19)

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On 10 March 2020, FDA announced that it is postponing most foreign inspections through April 2020.  This action comes as the latest in a series of agency responses to the coronavirus (COVID-19) outbreaks in foreign...more

Goulston & Storrs PC

An Unintended Interruption to the Global Supply Chain

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The current outbreak of COVID-19 (the coronoavirus) will be a test of the global supply chain’s strength in the face of unintended interruptions, and can be a lesson on building-in supply-chain contingency plans.  As a result...more

Morgan Lewis

Overview of Medical Device Regulation in China

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How is the manufacturing, marketing, distribution, and sale of medical devices regulated in the People’s Republic of China? This article outlines the regulatory framework and pathways, the classification of devices, and...more

Robins Kaplan LLP

Financial Daily Dose 11.13.2019 | Top Story: Buffeted by Changing Consumer Demands, Dean Foods Declares Bankruptcy

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Dean Foods, the largest milk company in the U.S., has filed for bankruptcy protection, a “fresh setback to a U.S. dairy industry struggling against declining U.S. milk consumption and rising competition.”  Industry experts...more

Robins Kaplan LLP

Financial Daily Dose 10.9.2019 | Top Story: Chair Powell says Fed will Expand its Treasury Securities Holdings

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Fed Chair Powell, speaking at an economics conference in Denver yesterday, made news by indicating that the central bank would “once again begin expanding its portfolio of government-backed securities”—a shift in policy...more

Robins Kaplan LLP

Your Daily Dose of Financial News

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Jobs report Friday again. Which, after February’s dismal numbers, is carrying extra importance today. We’ll be keeping an eye on US manufacturing, among other things. Here’s what to watch....more

A&O Shearman

China Announces Pilot Scheme for Tendering with Minimum Procurement Quantities

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On 15 November 2018 the Joint Procurement Office (the JPO) published its Paper on Centralized Drug Procurement in “4+7” Cities (the Paper), which launched the national pilot scheme for tendering with minimum procurement...more

Hogan Lovells

China Takes Significant Steps to Consolidate Generic Drug Industry and Lower Prices

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With the opportunity for global pharmaceutical companies to gain new access to the Chinese market presenting itself like never before, significant news broke on December 7, 2018, regarding a newly implemented pilot...more

Hogan Lovells

The life sciences industry under the antitrust spotlight in China: two practical points

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The simple fact is that the Chinese antitrust regulators are determined to up their enforcement activities in the life sciences industry. Almost immediately after drug pricing was liberalised in 2015, an antitrust enforcement...more

Robins Kaplan LLP

Your daily dose of financial news - The Brief – 8.23.16

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The 2d Circuit has refused the DOJ’s motion for reconsideration of the panel’s May decision overturning a jury verdict and accompanying $1.27 billion fine against Bank of America over its “Hustle” mortgage generation program....more

Akin Gump Strauss Hauer & Feld LLP

Red Notice Newsleter

Welcome to the May 2014 edition of Red Notice, a publication of Akin Gump Strauss Hauer & Feld LLP. This month, on the anticorruption front, Avon Products, Inc. (“Avon”) agrees to pay USD $135 million to settle a...more

The Volkov Law Group

Ten Required Steps To Ensure Effective Compliance Programs By Pharmaceutical And Medical Device Companies (Part III Of III)

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In response to the Glaxo controversy and the continuing risks of aggressive FCPA enforcement, drug and device companies need to review and enhance their anti-corruption compliance programs. ...more

The Volkov Law Group

Pharmaceutical And Medical Device Companies: Taking It On The Chin (Part II Of III)

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As the Glaxo controversy unravels each day, it is important to remember the enforcement context in which the current prosecution in China is occurring. ...more

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