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China Biologics Prescription Drugs

Ropes & Gray LLP

China Formalizes Regulatory Data Protection Mechanism

Ropes & Gray LLP on

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

Morgan Lewis

China Boosts Regulatory Framework for Local Pharmaceutical Manufacturing

Morgan Lewis on

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

What's New in Washington - September 2020

As the November elections rapidly approach, Congress faces a number of key legislative deadlines, including the need to fund federal agencies and extend expiring federal programs at the conclusion of the current fiscal year...more

McDermott Will & Schulte

FDA Update: COVID-19 Testing, Vaccine Development and Other Impacts

In response to the United States’ rapidly evolving public health situation, the US Food and Drug Administration (FDA) recently released guidance on high-complexity in vitro diagnostic (IVD) tests for COVID-19. This article...more

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