德勤-关注中国人类遗传资源管理，为药企研发保驾护航（英文）-2021.4-16页_398kb

Summary of Safeguarding Biopharma R&D in China

Core Content

China has significantly strengthened its human genetic resources (HGR) regulations, marking a new era in the management of HGR. The Regulations on the Management of Human Genetic Resources of the People's Republic of China, officially introduced in 2019, have set a comprehensive framework for the oversight of HGR use in research. These regulations emphasize compliance, transparency, and the protection of genetic data and biological materials, especially in international collaborations.

Main Points and Key Information

1. Regulatory Scope and Definition

• The HGR definition includes both materials (e.g., whole blood, tissue biopsies) and information (e.g., genetic sequencing data).
• The HGR Administrative Office (HGRAO) oversees the review and approval of studies involving HGR, with a focus on highly sensitive data and materials.
• Regulation scope includes:
  • Registration researches (Phase I-III clinical trials)
  • Early phase exploratory researches (e.g., phase 0 studies in cancer)
  • Post-market studies (e.g., real-world label expansion)

2. International Collaboration Requirements

• All international collaboration research must be subject to HGR compliance.
• Key HGR approvals required for human-based studies in China include:
  • Applications for international collaboration research (specifying stakeholders, IP plans, sample sizes)
  • Applications for collection and storage of HGR by Chinese collaborators
  • Applications for exportation of human genetic samples
  • Data filling and backup before transmitting data to ex-China jurisdictions (including Hong Kong/Macau)

3. Regulatory Enforcement and Penalties

• The HGRAO has strengthened enforcement, leading to a decline in average approval rates over the past five years.
• Penalties for violations can significantly disrupt R&D programs, potentially delaying them by up to 1.5 years.
• Biosecurity Law and possible inclusion of HGR in Criminal Law will further increase the severity of enforcement and legal consequences.

4. Expected Policy Evolution

• HGR regulations are expected to evolve rapidly, providing more clarity and flexibility.
• A category-based approach may be introduced for data filing and backup, such as:
  • Toxicity data filed retrospectively
  • Non-time-sensitive data (e.g., biomarker data) filed before overseas transfer

5. Capabilities Localization

• Local vendors (both domestic and global-based in mainland China) are increasingly encouraged for sample testing and data analysis.
• Data localization is more challenging due to perceived capability gaps, but international vendors may consider establishing local infrastructure.
• Examples include Foundation Medicine One and Di An Lab collaborating on genomic sequencing data to meet local compliance needs.

6. Robust HGRAO Communication

• HGRAO has been engaging with the industry through workshops, training sessions, and industry forums.
• Companies are advised to engage with HGRAO through diversified channels, including virtual training, office visits, and industry association participation.
• Cross-functional collaboration (government affairs, clinical development, IP/legal) is essential for effective HGRAO engagement.

7. Proactive Legal and Compliance Risk Mitigation

• Companies must adopt a proactive approach to prevent, detect, and mitigate non-compliance and legal risks.
• Key actions include:
  • Developing standard processes and SOPs
  • Conducting internal and external audits
  • Establishing efficient decision-making models for issue resolution
  • Implementing IT solutions to track study submissions, analyze rejections, and catalog best practices

8. Organizing for HGR Management Excellence

• HGR governance must be optimized to ensure a cohesive approach to oversight and compliance.
• A dedicated HGR operating model should be established, including:
  • Internal champions for HGR management
  • Cross-functional involvement in specialized areas like legal, procurement, and data management
• HGR-related KPIs should be explicitly defined and monitored, including:
  • Productivity (approval rates)
  • Competency (HGR awareness)
  • Compliance (inspection readiness)
  • Reputation (perceived excellence by regulators and peers)
• Data-driven approaches are critical, supported by IT systems for:
  • Study application & submission management
  • Sample flow and usage tracking
  • Source file curation for inspections
  • Training deployment and performance tracking

Conclusion

HGR regulations in China are becoming more stringent, explicit, and globally aligned. Companies, especially MNC biopharmas, must adapt by establishing proactive compliance strategies, localization of capabilities, and robust HGRAO communication. These measures will help ensure HGR management excellence, which is now a core competency for R&D organizations aiming to succeed in the Chinese market.

Contacts

Authors

• David Xie - Consulting Director, Deloitte China Life Sciences & Health Care
  Email: daxie@deloitte.com.cn
• Megan Qian - Consulting Senior Consultant, Deloitte China Life Sciences & Health Care
  Email: mqian@deloitte.com.cn
• Kylie Dong - Consulting Analyst, Deloitte China Life Sciences & Health Care
  Email: kydong@deloitte.com.cn

China LSHC Industry Leadership Team

• Jens Ewert - Industry Leader
  Email: jensewert@deloitte.com.cn
• James Zhao - Tax & Legal Leader
  Email: jazhao@deloitte.com.cn
• Bill Yang - Financial Advisory Leader
  Email: bilyang@deloitte.com.cn
• Lawrence Jin - Assurance & Audit Leader
  Email: lawrjin@deloitte.com.cn
• Andrew Yu - Consulting Leader
  Email: andryu@deloitte.com.cn
• Yvonne Wu - Risk Advisory Leader
  Email: yvwu@deloitte.com.cn

Office Locations

• Beijing: 12/F China Life Financial Center, No. 23 Zhenzhi Road
• Changsha: 20/F Tower 3, HC International Plaza, No. 109 Furong Road North
• Chengdu: 17/F China Overseas, No. 365 Jiaozi Avenue
• Chongqing: 43/F World Financial Center, 188 Minzu Road
• Dalian: 15/F Senmao Building, No. 147 Zhongshan Road
• Guangzhou: 26/F Yuexiu Financial Tower, No. 28 Pearl River East Road
• Hangzhou: Room 1206, East Building, Central Plaza, No. 9 Feiyunjiang Road
• Harbin: Room 1618, Development Zone Mansion, No. 368 Changjiang Road
• Hefei: Room 1201 Tower A, Hua Bang ICC Building, No. 190 Qian Shan Road
• Hong Kong: 35/F One Pacific Place, 88 Queensway
• Jinan: Units 2802-2804, 28/F China Overseas Plaza Office, No. 6636 2nd Ring South Road
• Macau: 19/F The Macau Square Apartment H-L, 43-53A Av. do Infante D. Henrique
• Mongolia: 15/F, ICC Tower, Jamiyan-Gun Street, 1st Khoroo, Sukhbaatar District
• Nanjing: 40/F Nanjing One IFC, No. 347 Jiangdong Middle Road
• Ningbo: Room 1702 Marriott Center, No. 168 Heyi Road
• Sanya: Floor 16, Lanhaihuating Plaza, No. 279 Xinfeng Street
• Shanghai: 30/F Bund Center, No. 222 Yan An Road East
• Shenyang: Unit 3605-3606, Forum 66 Office Tower 1, No. 1-1 Qingnian Avenue
• Shenzhen: 9/F China Resources Building, No. 5001 Shennan Road East
• Suzhou: 24/F Office Tower A, Building 58, No. 58 Su Xiu Road
• Tianjin: 45/F Metropolitan Tower, No. 183 Nanjing Road
• Wuhan: Unit 1, 49/F New World International Trade Tower, No. 568 Jianshe Avenue
• Xiamen: Unit E, 26/F International Plaza, No. 8 Lujiang Road
• Xi'an: Room 5104A, 51F Block A, Greenland Center, No. 9 Jinye Road
• Zhengzhou: Unit 5A10, Block 8, Kailin Center, No. 51 Jinshui East Road