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Clinical Trials China Genetic Materials

Katten Muchin Rosenman LLP

FDA Scrutinizes Clinical Trials Exporting U.S. Genetic Material

On June 18, 2025, the U.S. Food and Drug Administration (“FDA”) announced an immediate review of new clinical trials that export American citizens’ biological materials to countries of concern, such as China, for genetic...more

Hogan Lovells

China update: Human Genetic Resources Administration Rules support HGR Implementing Rules

Hogan Lovells on

After years of waiting, China’s Ministry of Science and Technology (MOST) finally released the final version of the Implementing Rules on the Human Genetic Resources Administration Rules (Implementing Rules) on 1 June 2023,...more

Hogan Lovells

China's draft implementation rules on human genetic resources: potential changes on HGR Supervision?

Hogan Lovells on

The Ministry of Science and Technology of China has finally issued the draft of Implementation Rules for the Regulations of Human Genetic Resources Administration for public comments on March 21, 2022, which gives more...more

Goodwin

Draft Implementing Rules of China’s Human Genetic Resources Regulations as Applied to Foreign Persons

Goodwin on

The Administrative Regulations of the People’s Republic of China on Human Genetic Resources (the “Regulations”), promulgated by China’s State Council, have been in effect for almost three years. As the administrative...more

Morgan Lewis

Impact of Recent China Data Protection Laws on Asian Life Sciences Industry

Morgan Lewis on

Multinational pharmaceutical companies, by nature of their business, handle a great deal of data, often transferred across borders, whether based on research, clinical trial data, and employee personal data....more

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