HGR is the regulatory acronym for Human Genetic Resources, specifically referring to the stringent set of regulations in China governing the collection, preservation, utilization, and outward transfer of human genetic materials and associated data. This regulatory framework encompasses biological samples like blood, tissues, and saliva, along with the genomic and genetic information derived from them, all of which are crucial for clinical trials and research in hormonal health. Compliance is mandatory for all foreign entities and international collaborations conducting research within the country.
Origin
The regulatory oversight of HGR in China formally began with the Administrative Provisions on Human Genetic Resources in 1998, with significantly strengthened rules implemented in 2019 and subsequent detailed implementation rules in 2023. This framework is fundamentally rooted in national security and public interest concerns regarding the vast and unique genetic data of the Chinese population. The regulations create a distinct legal landscape for global pharmaceutical and biotech companies.
Mechanism
The HGR mechanism requires mandatory administrative approval or filing with the relevant Chinese authorities, primarily the Ministry of Science and Technology (MOST) and recently the National Health Commission (NHC), before any HGR-related activities can commence. For hormonal research, this includes obtaining consent and a specific license for the cross-border transfer of genetic data, ensuring that all research remains under Chinese oversight. This stringent control mechanism safeguards national genetic information while permitting regulated international scientific collaboration.
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