New NMPA GMP Annexes for Pharmaceutical Excipients and Packaging Materials Effective July 2025
Effective July 1, 2025, the National Medical Products Administration (NMPA) of China will implement new annexes to the “Good Manufacturing Practice (GMP) for Pharmaceutical Products (2010 Revision),” which introduce defined GMP requirements for pharmaceutical excipients and drug packaging materials. This is the first time such requirements have been formally established in China for these product categories. International manufacturers exporting to China should be aware that the annexes apply equally to foreign enterprises and include provisions for quality management systems, supplier audits, and change control processes. Full compliance is expected by December 31, 2025. The annexes bring China’s requirements for excipients and packaging materials more in line with internationally recognized GMP frameworks, and may warrant early review and planning, particularly for companies unfamiliar with the local regulatory environment.
Key Points Interpretation
According to the announcement, manufacturers of pharmaceutical excipients and packaging materials are required to fully implement GMP requirements by December 31, 2025. The main contents of the announcement are as follows:
1. Scope of Application: This announcement applies to all enterprises engaged in the production, sale, and use of pharmaceutical excipients and packaging materials within China, including foreign manufacturers whose products are intended for the Chinese market.
2. Establishment of a Robust Quality Management System by Manufacturers: Enterprises need to establish a comprehensive quality management system that covers the procurement of raw materials, production process control, product quality inspection, storage, and transportation.
- Production Environment: It must meet GMP standards to ensure no contamination or cross-contamination, with regular environmental monitoring.
- Personnel Training: Senior enterprise managers must ensure the independent operation of the quality department. Production and quality leaders must meet professional background and experience requirements. Regular training for employees is required to ensure they possess the necessary professional knowledge and skills
- Facility Upgrades: Factory design must meet the high standards of GMP to ensure the cleanliness and controllability of the production environment.
3. MAH to Strengthen Material Quality Management
- Implementation of Drug Quality Responsibility: Evaluate and approve all suppliers, establish supplier quality files, conduct strict incoming inspections, and regularly carry out quality retrospective analyses to ensure that pharmaceutical excipients and packaging materials meet drug requirements.
- Strengthening Supplier Audits: Assess suppliers’ production capacity and quality systems to ensure all raw and auxiliary materials meet drug requirements. Regular on-site audits of key suppliers are required.ersonnel Training.
- Strengthening Material Quality Control
- Strengthening Supplier Change Management: When suppliers implement changes, MAHs need to assess the impact of changes on drug quality and decide whether to continue cooperation.
4. Initial Compliance: Enterprises should initiate internal evaluation and rectification work as soon as possible to ensure full compliance with the new requirements by January 1, 2026. Specific recommendations include:
- Facility and Equipment Upgrades: Upgrade production facilities and equipment as required by the new regulations.
- Personnel Training: Enhance employees’ understanding and execution of the new regulations to ensure the effective operation of the quality management system.
- Supplier Management: Establish closer cooperation with suppliers to ensure the quality of raw and auxiliary materials meets the requirements of the new regulations. By implementing the above measures, enterprises will be better able to adapt to the new regulations, improve product quality, and enhance market competitiveness.
5. Transition Arrangements: Enterprises that completed production before July 1, 2025, will have 12 months to achieve compliance. New enterprises must meet all requirements at the time of their first application.
Opportunities and Challenges for Overseas Manufacturers
1. Market Access Advantages: The implementation of the new annexes will significantly raise the market entry threshold in China. For overseas enterprises with international GMP certification, their compliance advantages can quickly translate into market share:
- First-mover Advantage: Enterprises that pass the review first will enter the NMPA’s “green channel,” shortening the product registration cycle.
- Brand Trust: GMP certification serves as a product quality endorsement, helping enterprises secure long – term cooperation with Chinese drug firms.
2. Compliance Costs and Response Strategies: Although the new regulations raise technical requirements, overseas enterprises can alleviate compliance pressure in the following ways:
- Leverage the Transition Period: Develop a phased rectification plan based on their specific situation, prioritizing high-risk areas.
- Localization Cooperation: Partner with local Chinese service providers (such as Cisema) to reduce communication and implementation costs.
Further Information
To read the original NMPA announcement about implementing new GMP annexes for pharmaceutical excipients and packaging materials, please click here.
If you are a pharmaceutical excipient or packaging material manufacturer with questions about how to comply with the new GMP annexes or what steps are required for market access in China, please contact Cisema.
