Nov. 19th, 2021

Pharmaceutical

China DMF Filing, Review & Approval System for APIs, Pharmaceutical Excipients & Packaging Materials

China's drug review & approval system has undergone substantial reforms since it joined the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) in 2017. One of the reforms is changing of the review & approval system for active pharmaceutical ingredients (APIs), pharmaceutical excipients and packaging materials (the three materials for making finished drugs will be referred to as AEPs in the following text). The article's content:
  1. Chronology of Chinas' AEP Review & Approval System
  2. Competent Authorities
  3. Obligations of Pharma Companies
  4. DMF Filing for AEPs: Regulatory Requirements
  5. General Procedures for DMF Filing, Review and Approval of AEPs in China
  6. Impacts of the New Associated Review & Approval System
  7. Comparison of AEP Management Systems in China, the US, and EU

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1. Chronology of China's AEP Review & Approval System

Before Aug. 10, 2016, AEPs are managed under the Separate Review & Approval System in China. Companies need to apply for AEP product registration first and can only produce or import them after receiving the license for production or importation. On Aug 10, 2016, the former China Food and Drug Administration (CFDA) released the Associated Review & Approval of Pharmaceutical Excipients, Packaging Materials and Finished Drug Products (No. 134 Announcement in 2016) 1. Since then, manufacturers of pharmaceutical excipients and packaging materials are required to submit DMFs (Drug Master Files) to the regulator for format reviews. Upon submission of the drug registration application, excipients and packaging materials will undergo technical reviews along with the associated finished drug products. The API registration system remained unchanged. On Nov. 30, 2017, CFDA published the Announcement on Adjusting the Review & Approval System for APIs, Pharmaceutical Excipients and Packaging Materials（No. 146 Announcement in 2017)2. APIs got included into the associated review & approval system. In addition, an online DMF filing system for AEPs was launched by the Center for Drug Evaluations (CDE). In July 2019, China National Medical Products Administration (NMPA), founded based on CFDA, issued the Announcement on Improving the Associated Review & Approval and Supervision of Drugs (No. 56 Announcement in 2019)3. The announcement currently functions as effective regulations on AEPs. In Apr. 2020, NMPA released the consultation draft of Administrative Provisions for Associated Review & Approval of Chemical APIs, Pharmaceutical Excipients and Packaging Materials.4 The draft, though not effective yet, specified more details for AEP management in the future.

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