Summary
(1) The National Medical Products Administration (NMPA) has announced the implementation of the 2025 edition of the Chinese Pharmacopoeia, also known as the China Pharmacopoeia (hereinafter referred to as the Pharmacopoeia). This announcement was published on October 1, 2025, and is effective as of that date. The Pharmacopoeia is a crucial component of national medical product standards, which all relevant units, including pharmaceutical manufacturers, importers, operators, and users, must adhere to.
(2) The 2025 edition of the Pharmacopoeia includes various sections, including explanatory notes, product standards, general technical requirements, and guiding principles. All pharmaceutical companies that have been granted a marketing license and those that produce and sell pharmaceuticals must comply with this announcement and the relevant requirements of the Pharmacopoeia.
(3) The implementation of the 2025 edition of the Pharmacopoeia has led to the abolition of corresponding standards in previous editions of the Pharmacopoeia, as well as standards issued by local authorities. However, products that are not included in the 2025 edition of the Pharmacopoeia must still comply with the relevant general technical requirements of the Pharmacopoeia.
(4) Pharmaceutical companies that have been granted a marketing license must conduct a comparative study and evaluate whether their registered standards comply with the new Pharmacopoeia standards. If necessary, they must submit an application to modify their registered standards before the implementation date.
(5) The implementation of the 2025 edition of the Pharmacopoeia also requires pharmaceutical companies to modify their product recipes, production processes, and raw materials, as well as the packaging materials and containers that come into direct contact with the pharmaceuticals. These modifications must be approved, registered, or reported in accordance with the relevant regulations and guidelines.
(6) For generic pharmaceuticals, the quality control requirements may differ from those specified in the Pharmacopoeia. In such cases, the registered standards must be implemented in accordance with the approved pharmaceutical registration standards.
(7) The 2025 edition of the Pharmacopoeia includes revised generic names for certain pharmaceuticals. These pharmaceuticals must use the revised generic names specified in the Pharmacopoeia, while the original names may be used as transitional names until the next edition of the Pharmacopoeia is implemented.
(8) The NMPA has announced that all new pharmaceutical registration applications must comply with the requirements of the 2025 edition of the Pharmacopoeia. For existing registration applications that have been reviewed but not completed, the review and approval process will be conducted in accordance with the requirements of the 2025 edition of the Pharmacopoeia.
(9) Pharmaceutical companies must take proactive measures to prepare for the implementation of the 2025 edition of the Pharmacopoeia and report any issues or problems encountered during the implementation process to the National Pharmacopoeia Committee. They must also continuously research and improve pharmaceutical quality standards to enhance the quality control level.
(10) The NMPA has also announced that it will establish a "Pharmacopoeia Implementation Column" on its official website to provide technical guidance and training, as well as to address any issues or problems that may arise during the implementation process.
(11) In summary, the 2025 edition of the Pharmacopoeia has been implemented, and all relevant units must comply with its requirements. Pharmaceutical companies must modify their products, production processes, and quality standards to meet the new requirements, and the NMPA will provide technical guidance and support to ensure a smooth implementation process.