Drug Master File system of China （Part 1）

Chapter 1 Introduction on Bundling review Regulation in China

1.    Introduction

Since China drug regulation reform from 2015, China Food and Drug Administration (CFDA, previous name of NMPA) has launched a reform of regulation system for drugs and medical devices according to the opinions of the State Council, aiming at resolving the backlog of registration applications, expediting the application procedure in China, and promoting the international practice. NMPA published a series of reform measures including but not limited to “Optimizing the review process”, “implementing new drug category”, “encouraging innovation”, “joining ICH”and “implementing Marketing Authorization Holder (MAH)”. Bundling Review and Approval for Active Pharmaceutical Ingredients (APIs), Excipients and Packaging materials, is one of the big reforms. As part of the reform, implementing drug master file (DMF) system for APIs, Excipients and Packaging materials. Bundling reviewing for APIs, Excipients and Packaging materials is necessary when submitting a drug product.

Before 2015, the review and approval system for APIs, Pharmaceutical Excipients and Pharmaceutical Packaging Materials in China operated under the regulation of administrative license. The review and approval of APIs, excipients and packaging materials were separated from those of drug products. The policy of separate evaluation solely focused on the quality of APIs, Excipients and Packaging Materials, with limited consideration given to the quality of drug products and lacked a comprehensive evaluation of the effectiveness, safety and quality of drug products. 

In the past few years, China National Medical Products Administration (NMPA) has issued a series of regulations, continuously improved the process step by step, and successfully established a comprehensive system (i.e., China DMF System) for Bundling Review and Approval. Some core regulations and provisions during this period are shown in Table 1 below. To date, the critical regulation governing the China DMF procedure is outlined in the “Announcement of the National Medical Products Administration on Further Improving the Bundling Review and Approval with Drug Product and its Related Supervision Matters (No.56 2019),” which was issued by the NMPA in July 2019.

Table 1 Key regulations and provisions for China DMF

2 Scope and Category Description

The scope of the DMF procedure in China includes 3 categories: APIs (only small modular), pharmaceutical excipients used in various drug products, primary packaging materials (including direct contact with packaging containers for pharmaceutical products).

Additionally, this includes packaging materials for APIs (including biological APIs). Furthermore, pharmaceutical excipients that have been used in food and drugs for a long period with recognized safety may not require DMF filing (refer to Appendix 3 of Announcement No. 56), with this list being periodically updated. The comparative table on APIs, Excipient, and Packaging materials is presented in below Table 2. 

Table 2 Comparison on APIs, Excipients, and Packaging materials