Shanghai Government and Enterprise Collaborate to Forge New Compliance Model

To further enhance the standardized operations and risk management of pharmaceutical companies and support the innovative development of the biopharmaceutical industry, the Shanghai Market Regulation Bureau's Enforcement Team and INNOVENT BIO (信达生物) held a signing ceremony for compliance system construction cooperation on December 23. A memorandum of guidance on compliance system development was signed, marking a new model of government-enterprise collaboration in compliance governance.

According to the memorandum, the two parties will engage in systematic cooperation focusing on key areas of compliance governance for pharmaceutical enterprises. The Enforcement Team will provide policy guidance and professional support in five major areas: compliance in drug promotion and commercial marketing, academic exchange management and risk prevention, drug pricing behavior standards, distributor management system development, and trade secret protection. This initiative aims to help companies clarify legal boundaries, strengthen internal control mechanisms, and mitigate compliance risks at the source.

Ni Long, head of the Tenth Division of the Shanghai Market Regulation Bureau's Enforcement Team, emphasized that administrative enforcement is not only about penalizing violations but also about preventing them. This collaboration seeks to enhance corporate compliance capabilities proactively.

The cooperation will establish a regular, multi-level, and efficient communication mechanism. Through policy consultations, regulatory guidance, risk alerts, rectification supervision, emergency response support, compliance training, and policy research, both sides will strengthen information sharing and issue resolution to ensure detailed implementation of compliance requirements.

Zhao Lei, General Manager of INNOVENT BIO Shanghai, stated that the company will use this agreement as an opportunity to reinforce standardized management and risk control, fostering innovation with higher-level institutional safeguards and contributing to the high-quality development of Shanghai's biopharmaceutical industry.

This collaboration represents a significant step in deepening government-enterprise synergy and exploring a regulatory model centered on "preemptive guidance, risk prevention, and co-governance." It embeds compliance into the entire process of corporate governance and innovation. Moving forward, the Shanghai Market Regulation Bureau's Enforcement Team will use this partnership as a benchmark to expand compliance initiatives in the pharmaceutical sector, promoting a shift from "passive compliance" to "proactive compliance" among enterprises. This effort will help create a fair and orderly pharmaceutical market environment, supporting Shanghai's biopharmaceutical industry in achieving high-quality growth.