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Provisions for Medical Device Registration and Filing
2024-06-05
Promulgated by SAMR Decree No. 47, issued on August 26, 2021 and shall go into effect as of October 1, 2021
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Provisions for In-vitro Diagnostic Reagent Registration and Filing
2024-06-05
Promulgated by SAMR Decree No. 48, issued on August 26, 2021 and shall go into effect as of October 1, 2021
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Provisions for Toothpaste Regulation
2024-06-05
Promulgated by SAMR Decree No. 71, issued on March 16, 2023 and shall go into effect as of December 1, 2023
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NMPA Announcement on Adopting ICH Guidelines M10 Q&As and FAQs
2023-07-04
To align the technical standards for drug registration with international standards, the NMPA upon deliberation decided to adopt the ICH(International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) Guidelines M10: Bioanalytical Method Validation And Study Sample Analysis (hereinafter referred to as M10) Q&As documents and FAQs documents.
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Special Provisions for TCM Registration released
2023-02-10
On Feb 10, the Special Provisions for Traditional Chinese Medicines Registration (hereinafter referred to as the Special Provisions) is issued by China NMPA and will take effect on July 1, 2023.
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Provisions for Supervision and Administration of Online Drug Sales
2022-12-29
Promulgated by Decree No. 58 of the State Administration for Market Regulation on August 3, 2022, these Provisions shall go into effect as of December 1, 2022.