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Insights and Analysis

Key considerations for life sciences demerger deals in China

This article discusses the most important legal and regulatory considerations for life sciences companies considering a demerger in China. The authors address the challenges and issues...

Insights and Analysis

Recent regulatory updates in China's Life Science Sector to start the year 2024

This article aims to introduce three recent regulatory updates in China’s life science sector. These updates involve incentives for locally-manufacturing approved foreign drugs,...

News

JPM2024: Impact of China’s HGR Rules on clinical trials and scientific studies involving China sites

Life sciences companies engaged in early development programs face a number of strategic considerations, such as where and how to administer the early stage scientific studies and each...

Insights and Analysis

Highlights on China’s Long-awaited Implementing Rules on Human Genetic Resources Administration Rules

For the purpose of providing further detailed guidance on the implementation of the Human Genetic Resources Administration Rules released in May 2019, after years of waiting, China’s...

News

Spotlight on Greater China: antitrust and regulatory risks in life sciences distribution channels

As part of a new Asia-Pacific (APAC) Life Sciences and Health Care webinar program designed both for companies with commercial interests in APAC and for companies based in the region, Hogan ...

Insights and Analysis

Accelerating Innovation: A New China Rule for Innovative Drug Registration Communication and Review

On March 31, 2023, the Center for Drug Evaluation under the PRC National Medical Products Administration issued the Work Specification for Accelerating the Review of Innovative Drug...

Insights and Analysis

The first pharmacovigilance rules in China: Practical GVP guidelines released by a provincial government

On May 7, 2021, the National Medical Products Administration released the Good Pharmacovigilance Practices of China, requiring market authorization holders to carry out certain...

Insights and Analysis

Regulation update in real-world research of unregistered drug and change during drug application review

On November 16, 2022, the CDE, together with Hainan MPA and Lecheng Bureau, released the Implementation Measures for Carrying out Real-World Research on Drugs (“2022 Implementation...

Insights and Analysis

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

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...

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