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China Generic Drugs Prescription Drugs

Ropes & Gray LLP

China Formalizes Regulatory Data Protection Mechanism

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Recently, the National Medical Products Administration (NMPA) issued the draft version of 'Implementation Measures for Drug Trial Data Protection (hereinafter referred to as the 'Draft for Comments'), aiming to clarify the...more

Axinn, Veltrop & Harkrider LLP

Will India Replace China in the U.S. Drug Supply Chain?

In a recent opinion piece in Newsweek, Dr. Rahul Tiwari asserts that pharmaceutical companies in India have an opportunity to supplant China's dominant position in producing active pharmaceutical ingredients ("API's") and...more

Jones Day

Patent Linkage and Article 76 Proceedings in China: A Litigator's Perspective

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China has recently unveiled its own version of a patent linkage system that has been highly watched by stakeholders and industry observers.  This new system will also create a new form of pharmaceutical patent litigation in...more

Hogan Lovells

China's IP Administration publishes Draft Administrative Adjudication Measures for Patent Linkage

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On 9 February 2021, China's National Intellectual Property Administration ("CNIPA") published its Administrative Adjudication Measures For The Early Resolution Mechanism For Drug Patent Disputes. These Measures are aimed at...more

Jones Day

China Promulgates Fourth Amendment to Patent Law

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On October 17, 2020, the Standing Committee of the National People’s Congress in China promulgated the fourth amended Patent Law of the People’s Republic of China, which came into force in its original form in 1985, with...more

A&O Shearman

China: Patent Law Amendment brings sea change to pharmaceutical patent regime

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Article 76 of the Amendment establishes the longanticipated patent linkage scheme in China. It aims to allow early resolution of patent disputes between innovators and generic companies during the drug review and approval...more

Hogan Lovells

China adopts revised patent law with Hatch-Waxman-like incentives for innovative drugs

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On October 17, the National People’s Congress (NPC) formally adopted a revised patent law, which will take effect on June 1, 2021. The new law includes significant changes in the intellectual property legal framework with...more

Hogan Lovells

China’s NMPA releases proposal for modified “Hatch Waxman” following patent law reform

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On 11 September 2020, China’s National Medical Products Administration (NMPA, formerly “China Food and Drug Administration”) published its proposed regulation on patent linkage, “Measures for the Implementation of the Early...more

Eversheds Sutherland (US) LLP

US-China Trade Agreement - Pharma impacts

President Trump has signed Phase I of a much anticipated multi-part trade agreement between the United States and China with provisions that will aid the branded pharmaceutical industry. One of the main goals of the agreement...more

Verrill

Is the New U.S.-China Agreement What Was Prescribed?

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The trade relationship between China and the United States has been top of mind for businesses over the past year. In spring 2018, Chinese President Xi Jinping denied the U.S. Government's request to end subsidies for key...more

Robins Kaplan LLP

Financial Daily Dose 7.29.2019 | Top Story: Pfizer and Mylan Join Forces to Create Generics Powerhouse

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Drug giants Pfizer and Mylan have inked a deal that will merge the former’s off-patent drugs with the latter’s generics business, a tie-up that creates a mammoth global seller of lower-priced medicines....more

Hogan Lovells

China: Survival of the Fittest or Cheapest?

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The past year is set to be a milestone year for China’s pharmaceutical regulatory reform as the newly formed National Medical Products Administration (NMPA) continues to aggressively cut back on red tape for new drug...more

Hogan Lovells

Pharma Companies May Benefit from Proposed Patent Law Changes in China; Public Comment Invited

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On January 4, China’s National People’s Congress (NPC) released draft amendments to the Chinese Patent Law, proposing expanded and enhanced protections that may provide real benefits to companies that develop new drugs. ...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

China drug regulator calling on international pharmaceutical companies to bring “urgently-needed” new drugs to China

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On 8 August 2018, in an unprecedented regulatory action, the China National Drug Administration (CNDA) called on international pharmaceutical companies to bring 48 new drugs to China. These new drugs are viewed to be urgently...more

K&L Gates LLP

Global Food, Drugs, Medical Devices and Cosmetics Newsletter

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Welcome - We are pleased to provide you with the Spring edition of the Global Food, Drugs, Medical Devices and Cosmetics newsletter. As stated in our inaugural issue, this newsletter provides updates on important...more

Thomas Fox - Compliance Evangelist

What Hath GSK Wrought? More Compliance Lessons From China

In an article, entitled “GSK China probe flags up wider worries”, in the Wednesday edition of the Financial Times (FT) reporters Andrew Jack and Patti Waldmeir discussed the ongoing bribery and corruption scandal involving...more

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