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Regulatory Requirements China Prescription Drugs

McGuireWoods LLP

FDA to Expand Unannounced Inspections of Foreign Facilities — Manufacturers, Research Firms Should Prepare

McGuireWoods LLP on

On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced a plan to expand its use of unannounced inspections of foreign manufacturing facilities that produce foods, essential medicines and other medical products...more

A&O Shearman

China advances pharmaceutical data protection regime with new Draft Measures

A&O Shearman on

On March 19, 2025, China’s National Medical Products Administration (NMPA) released the Draft Measures for the Protection of Drug Trial Data (the “Draft Measures”), along with its accompanying implementation guidelines, the...more

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

Sheppard Mullin Richter & Hampton LLP

China Proposed New Anti-Monopoly Guidelines for the Pharmaceutical Sector

On August 9, 2024, China’s State Administration for Market Regulation (SAMR) released a draft of the Anti-Monopoly Guidelines for the Pharmaceutical Sector (hereinafter referred to as the “AMGP”) for public comment. The AMGP...more

Hogan Lovells

Senate passes online country of origin labeling requirements under the USICA

Hogan Lovells on

On 8 June 2021, the Senate passed the U.S. Innovation and Competition Act (USICA), which contains a wide range of provisions aimed at improving the United States’ global economic competitiveness, particularly toward China. ...more

Hogan Lovells

China: Survival of the Fittest or Cheapest?

Hogan Lovells on

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

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

Hogan Lovells on

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

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