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
3 Basic Requirements
- The bundling review and approval of APIs, Excipients and Packaging materials to bundle with drug products should be filed on the registration platform by the applicant/holder of the APIs, Excipients and Packaging materials. The applicant and/or holder of drug product registration should bundle used APIs, excipients and packaging materials with the platform registration data when submitting the DP registration application. In the event of failure to file on the platform due to some specific reasons, the applicant and/or holder of drug product registration should provide the whole technical data package of APIs, Excipients and Packaging materials together and integrate into the submission package of the drug product.
- The applicant/holder of APIs, Excipients and Packaging materials should maintain the registration information on the platform and be responsible for its authenticity and integrality. The domestic applicants/holders of the APIs, Excipients and Packaging materials are responsible for conducting DMF filing of its own products. The overseas Applicants/holders of APIs, Excipients and Packaging materials can register through a representative agency or agent based in China. related permanent representative agency or an authorized agency in China. The overseas holders and agencies shall be jointly responsible for the authenticity and integrality of the DMF filing packages.
- When the applicant/holder of a drug product submits the drug registration application, the registration No. of the APIs, Excipients and Packaging materials and a Letter of Authorization (LOA) from the applicant/holder of APIs, Excipients and Packaging materials are required.
- The drug product applicant/holder who shall undertake the main responsibility for the drug product quality, shall conduct an audit over the Quality Management System of manufacturers of the APIs, Excipients and Packaging materials, in accordance with the requirements of the drug registration regulation and post-marketing production management, to ensure full compliance with the requirements for pharmaceutical use.
- The regulatory authority shall be responsible for the confidentiality of the technical documents submitted by the applicant/holder of the APIs, Excipients and Packaging materials, and the technical information on the registration platform. The platform only discloses the following information: registration status identifier (A or I), registration No., name of the registered products, company's name (authorized agency's name), address for production, previous drug production license No. (if available), the validity period of original certificate of drugs (if available), product source, strengths, update date and other necessary information.
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