With the implementation of EU's GMP (Appendix 1) on Sterile Products, Chinese GMP (Appendix 1) has also undergone a significant upgrade this year. This revision (draft for comments) aligns closely with international regulatory standards and perspectives. In recent years, Chinese pharmaceutical regulatory authorities have actively integrated into the international system and have formally applied to join PIC/S. The release of this Draft for Comments reflects the solid foundation already established in Chinese pharmaceutical industry and demonstrates the country's determination to join PIC/S. It will also accelerate the alignment of Chinese pharmaceutical industry with international standards, ensuring high-quality protection of public health and safety.

As a draft for comments, it is essential to gather industry feedback and make repeated revisions in combination with the actual situation in China. In what follows, Morimatsu's validation and consulting team will conduct a comparative analysis of the key differences between the two from multiple perspectives, fostering industry-wide discussion and learning.

1. Core Principles

The formal implementation of EMA's Appendix 1 on Sterile Products (2022 edition) builds on years of regulatory insights, further emphasizing the role and importance of quality risk management. It also introduces a comprehensive risk control requirement, i.e., Contamination Control Strategy (CCS), to identify and manage risks throughout the entire drug lifecycle, achieving a balance between risk levels and preventive/control measures, and optimizing benefits and efficiency.

Overall, NMPA's Appendix 1 on Sterile Products (draft for comments) shares a high degree of similarity with EMA's Appendix 1 (2022 edition), though it does not explicitly mention some of the prerequisites for implementing EMA's Appendix 1. It may take a longer period than the implementation of EMA's Appendix 1 on Sterile Products before this draft for comments is finalized and implemented.

2.Scope of Application

Article 2 of NMPA's (Appendix 1) on Sterile Products (draft for comments): This Appendix applies to the entire production process of sterile drug products as well as the sterilization and aseptic production processes of sterile APIs.

EMA's Appendix 1 on Sterile explicitly states that, certain principles (e.g., CCS) also apply to non-sterile products and the products requiring microbial load control. However, NMPA, considering the current state of domestic drug manufacturers, has not explicitly expanded the scope of this draft for comments.

3.Requirements for Personnel

Overall, NMPA places greater emphasis on personnel's professional experience, while EMA highlights comprehensive requirements, including education background, professional knowledge, skills, work experience/practical experience, and even stricter health standards.

Additionally, the draft for comments focuses more on contamination risks posed by personnel to products, overlooking potential contamination risks from protective measures (e.g., clothing, movements, etc.). These risks should also be holistically addressed in CCS.

4.Monitoring

Similarly, the draft for comments proposes monitoring specific stages of a product's lifecycle but does not directly reference the provisions of EMA's Appendix 1 on Sterile Products for overall process monitoring. For example, Section 9.14 of EMA's Appendix 1 mentions overall particle monitoring. Morimatsu suggests evaluating the overall particle trend in a specific area (unit/facility/production line) during environmental monitoring to guide the effectiveness of maintenance measures, identify potential risk sources promptly, and establish a dynamic closed-loop system of evaluation-identification-monitoring-analysis-review-maintenance, integrating dynamic management, risk management, and quality management measures/systems.

5.Equipment

Morimatsu believes that the EMA places greater emphasis on the importance of mechanization and automation, adhering to the concept that humans are the primary source of contamination and risk. When mechanization and automation can replace repetitive manual labor or mitigate certain risks, the EMA prefers mechanized solutions. Examples include the extensive use of barrier technologies, BFS, FFS, SUS, etc.

Summary

In summary, the NMPA's Appendix on sterile products (draft for comments) closely follows the EMA's Appendix 1 on sterile products, promptly releasing this draft for comments for public feedback. After thorough industry input, it will undergo iterative revisions to better align with the domestic industry environment. Consistently upholding the principle of "Quality by Design", quality, risk, measures, and costs all originate from design. This reflects the regulatory authorities' open and inclusive attitude and underscores the nation's emphasis on drug safety.

This draft for comments marks a positive beginning. The finalization and implementation process will require collaborative efforts between regulatory authorities and industry peers. Through continuous communication and feedback, the final regulations will embody both international perspectives and Chinese characteristics, comprehensively safeguarding drug safety and public health.

About Morimatsu LifeSciences

Morimatsu LifeSciences is a key business segment of Morimatsu International Holdings Limited (Stock Code: 2155.HK). It comprises Shanghai Morimatsu Pharmaceutical Equipment Engineering Co., Ltd., Morimatsu (Suzhou) LifeSciences Co., Ltd., Shanghai Morimatsu Biotechnology Co., Ltd., Shanghai Mori-Biounion Technology Co., Ltd., Shanghai Morisora Technology Co., Ltd., Bioengineering AG, Pharmadule Morimatsu AB, and its affiliated companies.

Morimatsu LifeSciences is dedicated in providing core equipment, process systems, and smart modular facility solutions, and services for the pharmaceutical, biopharmaceutical, medical aesthetics, and fast-moving consumer goods (FMCG) sectors including (cosmetics, food, and health supplements), as well as data centers.

Our team comprises highly experienced professionals with deep expertise in process R&D, engineering design, advanced manufacturing, compliance and validation consulting, production execution, and intelligent operations. With broad experience across diverse industries, we fully understand the unique characteristics and process requirements of various products. This enables us to deliver tailored, end-to-end process solutions from the conceptual design stage, precisely aligned with client’s specific needs.

Morimatsu LifeSciences has established a strong global presence, supported by advanced R&D centers, design hubs, and state-of-the-art manufacturing facilities worldwide. Our well-established service network spans Europe,USA,Asia-Pacific, and emerging markets. We have successfully delivered outstanding, customized solutions to clients in over 40 countries and regions, gaining extensive experience in international project execution.

As a multinational enterprise with core strengths in process technology, modular facility construction, and intelligent manufacturing, Morimatsu LifeSciences is dedicated to meeting the evolving equipment and system needs of our key industries. Through continuous innovation and technological advancement, we are steadily expanding our global footprint, driving our international strategy forward, and delivering Morimatsu’s expertise, reliability, and innovation to the global life sciences and related sectors.