Quick Guide to the New GMP Regulations

Release Dates of the New Version of Good Manufacturing Practice of Medical Products (GMP):

• Pharmaceutical Excipients and Packaging Materials: The National Medical Products Administration (NMPA) released the Appendices on Pharmaceutical Excipients and Packaging Materials under the Good Manufacturing Practice (2010 Revision) on January 2, 2025, with an effective date of January 1, 2026.

• Medical Devices: The NMPA released the new version of the Good Manufacturing Practice for Medical Devices on November 4, 2025, with an effective date of November 1, 2026, repealing the 2014 version.

• Draft of the 2025 Sterile Medicinal Products Appendix (for comments): The NMPA issued a notice on March 17, 2025, soliciting public comments on the proposed revision of the Sterile Medicinal Products Appendix under the Good Manufacturing Practice (2010 Revision).

The release of the new GMP reflects the overall direction of China’s drug regulatory system moving closer to international advanced levels, strengthening risk-based quality control throughout the entire process, and promoting high-quality industrial development. The new GMP versions across different fields (e.g., pharmaceuticals, medical devices, veterinary drugs) share common features: "more systematic framework, more detailed requirements, more advanced technology, and clearer responsibilities." The core upgrades can be summarized from the following dimensions:

Comprehensive Upgrading of the System Framework, Significant Increase in the Number of Clauses

The new GMP generally expands the chapter structure and increases the number of clauses. For example, the 2025 Sterile Medicinal Products Appendix adjusts from 15 chapters and 81 clauses (2010 version) to 12 chapters and 235 clauses. Newly included items such as pharmaceutical excipients and sterile packaging materials that come into direct contact with drugs are brought under GMP supervision, with clear requirements for aseptic assurance during their production processes, making the content more detailed and systematic. The GMP for medical devices increases from 81 to 132 clauses; the GMP for veterinary drugs increases from 95 to 287 clauses. New chapters focus on key areas such as "Validation and Qualification," "Contract Manufacturing and Outsourcing," and "Quality Risk Management," establishing a full-lifecycle quality management system covering R&D, production, testing, warehousing, and after-sales service.

Deep Integration of Quality Risk Management Concepts

The new GMP generally adopts Quality Risk Management (QRM) as a core principle, requiring enterprises to proactively identify, assess, and control risks in all aspects, including raw material procurement, process changes, deviation handling, and product release. For example, the introduction of the Contamination Control Strategy (CCS) requires enterprises to systematically establish and continuously update contamination control measures, covering the entire process from facility design, materials, and process validation, and to regularly evaluate effectiveness. It also requires risk-based determination of testing items (e.g., exemption of abnormal toxicity tests for biologics) and the establishment of dynamic risk assessment models for shared facility production decisions, among others.

Significantly Higher Requirements for Personnel Qualifications and Responsibilities

The educational background, professional qualifications, and competency of key personnel (e.g., company responsible person, production/quality management responsible persons, Qualified Person) are clearly specified. For example, medical device and pharmaceutical production companies require the production/quality responsible persons to hold at least a bachelor's degree or intermediate professional title, with relevant management experience. The GMP for veterinary drugs also emphasizes that key personnel must undergo systematic training and independently perform their quality duties.

Stricter Standards for Production Environment and Facilities

Cleanroom classification is more refined (e.g., Grades A, B, C, D), and dynamic monitoring becomes mandatory, especially for Grade A areas where particle and microbiological monitoring must be performed under simulated actual production conditions. The new standard also requires multi-dimensional control of airflow, differential pressure, temperature/humidity, surface and personnel microbiological levels, and introduces digital means such as online monitoring and real-time alarms.

Encouragement of Digital Transformation and Technological Upgrades

The new GMP explicitly supports the application of new technologies such as artificial intelligence, information systems, automatic recording devices, and Unique Device Identification (UDI). It requires enterprises to establish digital quality management systems that enable automatic data collection, storage, and traceability. For example, pharmaceutical water systems must be equipped with online TOC analyzers, and equipment calibration must cover new metrics such as "minimum weighable quantity."

Clarified Responsibilities in Contract Manufacturing and Supply Chain Management

In response to the prevalent industry practices of contract manufacturing and outsourcing, the new GMP adds dedicated chapters, clarifying that the marketing authorization holder (or filing party) is responsible for auditing, supervising, and quality releasing of contract acceptors, emphasizing quality control throughout the entire chain. It requires on-site audits of suppliers and the establishment of process control mechanisms for excipients, packaging materials, key equipment, etc.

High Alignment with International Standards (e.g., ICH, PIC/S, WHO)

The new GMP explicitly supports the application of new technologies such as artificial intelligence, information systems, automatic recording devices, and Unique Device Identification (UDI). It requires enterprises to establish digital quality management systems that enable automatic data collection, storage, and traceability. For example, pharmaceutical water systems must be equipped with online TOC analyzers, and equipment calibration must cover new metrics such as "minimum weighable quantity."

It should be noted that although the new GMP versions for different industries (pharmaceuticals, medical devices, veterinary drugs) have their own emphases, they all share the underlying logic of "Quality by Design (QbD)," "Continuous Process Verification," "Data Integrity," and "Patient Safety." Enterprises with existing production lines need to systematically conduct gap analyses, personnel training, equipment upgrades, and documentation system restructuring to achieve compliance transition.