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NMPA Announcement on the Matters Related to Optimizing the Application for Marketing and Registration of Drugs Manufactured Overseas and Marketed in China to be Transferred to Domestic Manufacturing
2024-04-23
To further optimize the foreign investment environment, promote the high-quality development in the pharmaceutical industry, improve the drug accessibility, and meet our people’s need, in accordance with the requirements of the Opinions on Further Optimizing the Foreign Investment Environment and Increasing the Efforts to Attract Foreign Investments (GF [2023] No. 11) issued by State Council, and the NMPA Announcement on Provisions for Post-approval Changes of Drugs (Interim) (No. 8, 2021), regarding the optimization of the application procedures for marketing and registration of drugs manufactured overseas and marketed in China to be transferred to domestic manufacturing, the relevant matters are hereby announced as follows.
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Innovative TCM Qinwei Granules Approved for Marketing by China NMPA
2024-03-15
Recently, the Category 1.1 innovative traditional Chinese medicine (TCM) Qinwei Granules of Chengdu Huaxi Natural Medicine Co Ltd was approved for marketing by the National Medical Products Administration.
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Tunlametinib Capsules approved with conditions for marketing by China NMPA
2024-03-15
Recently, the Category 1 innovative drug Tunlametinib Capsules (Chinese trade name: 科露平) of Shanghai KeChow Pharmaceuticals Co. Ltd was approved with conditions for marketing by the National Medical Products Administration with priority review and approval, which is applicable to patients with advanced melanoma containing anti-PD-1/PD-L1 treatment failure of the NRAS mutation.
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NMPA Announcement on Issuing the Procedures for Assessment of Drug Control Institutions of Technetium-Labeled and Positron Radioactive Pharmaceuticals (No. 21 of 2024)
2024-03-14
The NMPA organized to formulate the Procedures for Assessment of Drug Control Institutions of Technetium-Labeled and Positron Radioactive Pharmaceuticals, which are hereby issued and shall come into force as of the date of issuance. National Institutes for Food and Drug Control shall, as per its duties, guide the construction of relevant control institutions.
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Promulgation of the Rules for the Application of Discretion in Imposing Administrative Penalties in the Supervision and Administration of Medicinal Products
2024-02-23
Recently, the Rules for the Application of Discretion in Imposing Administrative Penalties in the Supervision and Administration of Medicinal Products were issued by China NMPA, which will come into force from August 1, 2024 onwards.
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Innovative TCM Jiuwei Cough Syrup Approved for Marketing by China NMPA
2024-02-21
Recently, the Category 1.1 innovative traditional Chinese medicine (TCM) Jiuwei Zhike Koufuye (cough syrup) of Zhuohe Pharmaceutical Group Co Ltd was approved for marketing by China NMPA.
