China NMPA Announces Action Plan to Upgrade Cosmetic Manufacturing Quality Management Systems

On December 12, 2025, the National Medical Products Administration (NMPA) released the “Three-Year Action Plan to Upgrade Cosmetic Manufacturing Quality Management Systems (2026–2028)” (“Comprehensive Cosmetics [2025] No. 70”), issued by the General Department of the State Food and Drug Administration.

Rather than introducing new formal compliance requirements, the action plan marks a regulatory recalibration. The NMPA is shifting its supervisory focus from whether cosmetic manufacturers have quality systems to whether those systems function continuously, consistently, and credibly across the full manufacturing lifecycle.

From Regulatory Framework Building to Systemic Quality Upgrading

The action plan represents a continuation of China’s broader effort to align “high-level safety” with “high-quality development” in the cosmetics sector. It builds directly on the regulatory architecture established in recent years under the “Cosmetics Supervision and Administration Regulation.”

The “Cosmetics Supervision and Administration Regulation,” together with the nationwide implementation of “Cosmetics Good Manufacturing Practice” since 2022, has established clear legal and technical baselines. Against this backdrop, the action plan focuses on systematically strengthening compliance by guiding regulators to concentrate on recurring challenges in quality system operation. These include the completeness of quality documentation, alignment between registration or filing materials and actual manufacturing processes, raw material compliance controls, and the performance of personnel in key positions.

Rather than addressing individual issues in isolation, the regulatory approach emphasizes raising overall quality system performance. The objective is to support a shift from basic compliance toward consistently robust and well-functioning quality systems across the industry.

How the Action Plan Reshapes Cosmetic Manufacturing Oversight

The plan introduces a more refined supervisory model that combines risk-based regulation, standardized enforcement, and heightened accountability. Together, these elements form a new regulatory paradigm for cosmetic manufacturing in China.

Risk-Based Supervision and Precision Regulatory Profiling

Under the action plan, cosmetic manufacturing enterprises will be subject to classified and tiered supervision. Inspection frequency and regulatory scrutiny will be determined by how effectively an enterprise’s quality management system operates, rather than by enterprise size or product volume alone.

Enterprises with weak system execution or poor risk prevention capability will face more intensive oversight. Those able to demonstrate stable, effective quality control may see reduced inspection pressure. Regulatory resources will increasingly follow quality performance.

At the same time, the NMPA frames supervision as both regulatory and corrective. Authorities are instructed to provide enterprise-specific guidance.

Unified GMP Interpretation

To address inconsistencies in enforcement, the plan calls for further harmonization in how Cosmetics GMP requirements are interpreted and applied. This seeks to reduce variability in inspection outcomes and compliance expectations.

Intelligent Quality Control

In parallel, regulators encourage the adoption of intelligent manufacturing and quality technologies, including digital systems, artificial intelligence, and Internet of Things applications.

These tools are intended to support full-process quality control, from raw materials through finished products, with enhanced traceability and strengthened risk identification capabilities.

Personal Accountability

The plan reinforces the principle of “penalties imposed on individuals,” extending enforcement beyond corporate entities to legal representatives, principal responsible persons, and other directly accountable personnel.

This approach directly links quality system performance to personal legal exposure. It is intended to prevent quality management from being treated as a delegated or symbolic function and to compel senior personnel to exercise genuine oversight.

Continuous Compliance Obligations

Importantly, quality system self-inspections and dynamic risk management are defined as ongoing obligations. Compliance is no longer treated as a temporary response to inspections, but as a continuous institutional requirement embedded in daily operations.

Implications for Overseas Cosmetic Companies

For overseas companies manufacturing cosmetics in China or placing products on the Chinese market, the action plan has important compliance implications, particularly in relation to registrant, filer, and entrusted manufacturer obligations.

Increased Exposure to Quality System Misalignment

Many overseas companies rely on domestic Chinese contract manufacturers while maintaining global quality systems developed outside China. The plan’s emphasis on consistency between manufacturing practice and registration or filing dossiers raises the risk that gaps in technology transfer or on-site execution will be identified as systemic defects.

Any divergence between approved documentation and actual production conditions may now trigger noncompliance findings, with direct regulatory consequences.

Expanded Liability of the China-Based Responsible Person

For overseas brands, the designated domestic responsible person is the legally accountable entity for product quality and safety. The action plan explicitly strengthens training, assessment, and accountability requirements for key personnel, including quality and safety responsible persons.

This means that the domestic responsible person can no longer function as a simple “document relay.” They must possess substantive, verifiable quality management capabilities and bear corresponding legal risks.

Practical Response Path for Overseas Companies

Given the plan’s three-year horizon and systemic scope, a passive compliance strategy carries increasing risk. A structured and forward-looking response is required.

Conduct a Focused Quality System Gap Assessment

Companies should perform targeted assessments of their internal quality systems and those of key contract manufacturers, benchmarking against “Cosmetics Good Manufacturing Practice” and the specific quality system weaknesses identified in the action plan.

Reviews should prioritize how systems operate in practice, including production consistency, self-inspection, and risk prevention, rather than the formal completeness of documentation.

Strengthen Domestic Responsible Person Capabilities and Supply Chain Control

Enterprises should reassess the competency, authority, and resourcing of personnel responsible for quality and safety compliance in China to ensure regulatory responsibilities are effectively discharged.

At the same time, oversight of contract manufacturers should be strengthened through defined governance structures, routine quality reviews, and data-sharing mechanisms that maintain continuous visibility into manufacturing activities and quality system performance.

Invest in Smart Quality Management Systems and Talent Development

In line with the action plan’s emphasis on informatization and smart supervision, digital and intelligent quality management tools should be incorporated into medium-term compliance planning. These systems enhance traceability and risk identification while supporting stable quality system operation.

Continuous training for senior management and personnel in key positions is equally important to ensure to meet increasingly stringent spot checks and competency assessments.

Engage Experienced Consultants

Aligning regulatory expectations with operational, auditable quality systems often requires expertise that bridges international quality standards and China’s regulatory framework. Specialized advisors, such as Cisema, support overseas companies through compliance planning, and capability development for personnel in key positions.

For companies operating under contract manufacturing models, specialized support can further assist in establishing structured audit and oversight frameworks to ensure outsourced production remains compliant and under effective control

A New Competitive Baseline for China’s Cosmetics Market

The NMPA’s three-year action plan defines a new development cycle for China’s cosmetics industry in which substantive manufacturing quality, technological innovation, and sustainable management capabilities form the core.

For overseas companies, those that proactively align China-specific quality systems with both regulatory expectations and global best practices will be better positioned to earn regulatory trust, protect brand credibility, and secure long-term China market access.

With more than two decades of China regulatory experience, Cisema can support overseas companies as they navigate this transition, from assessing existing compliance frameworks to readiness for regulatory scrutiny.

For companies seeking to strengthen China cosmetics compliance and manufacturing quality systems, contact Cisema today to discuss regulatory alignment.

Further Information

Explore Cisema’s services for cosmetics filing and registration in China.

References

“Three-Year Action Plan for Improving the Production Quality Management System of Cosmetics Enterprises (2026–2028)” (NMPA Announcement, Comprehensive Cosmetics [2025] No. 70) — National Medical Products Administration