[Legal News] Key Document Released: Transition from Foreign to Domestic Pharmaceutical Manufacturing
2024. 3. 1
[Legal News] Key Document Released: Transition from Foreign to Domestic Pharmaceutical Manufacturing
With the promotion of pharmaceutical, medical, and healthcare reforms in China, particularly the normalization and development of Value-Based Procurement (VBP) of pharmaceuticals, the market profitability of overseas-manufactured pharmaceuticals already launched in China is dwindling, thus prompting multinational pharmaceutical companies to adjust their manufacturing and sales strategies for these products in China. Amidst this situation, transitioning overseas-manufactured pharmaceuticals already launched in China to domestic manufacturing has become an important strategy.
Against this backdrop, the National Medical Products Administration announced on January 24, 2024, a notice titled "Optimization of Matters Concerning Market Authorization Applications for Transitioning Overseas Manufactured Pharmaceuticals Already Launched in China to Domestic Manufacturing" (referred to as the "Notice"), inviting public comments until February 24, 2024.
The content of the Notice includes the following three points:
1. When transitioning overseas-manufactured pharmaceuticals already launched in China to domestic manufacturing, domestic applicants must apply for market authorization in accordance with the requirements and procedures for market authorization of pharmaceuticals.
2. When transitioning overseas-manufactured pharmaceuticals already launched in China to domestic manufacturing, relevant pharmaceutical, non-clinical research, and clinical research data (where applicable) can be submitted based on the original registration application data for the product manufactured overseas, and additionally, relevant research data for the domestically manufactured products should be submitted. Specific requirements for application materials will be separately formulated and announced by the Drug Evaluation Center of the National Medical Products Administration.
3. Applications for market authorization of pharmaceuticals transitioning original research chemical and biological products to domestic manufacturing will be included within the scope of priority review and approval by the National Medical Products Administration.
Points 1 and 2 above align with the content specified in Article 10 of the "Administrative Measures for Drug Post-marketing Changes (for Trial Implementation) "[(2021) No.8], with no specific changes made in this Notice. Additionally, point 3 reflects one of the policies under the "Strengthening the Attractiveness of Foreign Investment in Key Areas" from the State Council's "Opinions of the State Council on Further Optimizing the Environment for Foreign Investment and Increasing Efforts to Attract Foreign Investment"[(2023) No. 11].
While the Notice primarily serves as a reaffirmation of existing legal content, it shows the Chinese government's commitment to enhancing foreign investment attraction in the pharmaceutical sector. If the Notice is officially implemented, it can be expected that guideline documents related to applications will also be published, significantly promoting the domestic manufacturing transition of overseas-manufactured pharmaceuticals already launched in China.
