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Breaking News! Notice from the National Medical Products Administration on Revising Certain Provisions of the “Administrative Measures for Drug Inspection (Trial)”

Breaking News! Notice from the National Medical Products Administration on Revising Certain Provisions of the “Administrative Measures for Drug Inspection (Trial)”

2023-08-04

To implement the requirements of laws and regulations such as the "Drug Administration Law" and the "Measures for the Supervision and Administration of Drug Production," and to further standardize drug inspection practices, the National Medical Products Administration has, based on the actual situation of drug inspection work, revised the "Measures for Drug Inspection Management (Trial)" (hereinafter referred to as the "Measures"). The main revisions and improvements have been made to articles in Chapter 3, "Inspection Procedures," and Chapter 9, "Handling of Inspection Results" (see Attachment 1).

Big News! Effective January 1, 2024! The National Medical Products Administration has released the "Measures for the Administration of Drug Standards" along with an interpretation of the policy!

Big News! Effective January 1, 2024! The National Medical Products Administration has released the "Measures for the Administration of Drug Standards" along with an interpretation of the policy!

2023-07-21

To standardize and strengthen the management of pharmaceutical standards, establish the most rigorous pharmaceutical standards, ensure the safety, efficacy, and controllable quality of drugs, and promote high-quality development of pharmaceutical products, the National Medical Products Administration has formulated the “Measures for the Management of Pharmaceutical Standards,” which are hereby promulgated and shall take effect as of January 1, 2024.

Notice from the Center for Drug Evaluation of the National Medical Products Administration on the Issuance of the “Guidelines for Accelerating the Review and Approval of Marketing Authorization Applications for Innovative Drugs (Trial)”

Notice from the Center for Drug Evaluation of the National Medical Products Administration on the Issuance of the “Guidelines for Accelerating the Review and Approval of Marketing Authorization Applications for Innovative Drugs (Trial)”

2023-04-03

Notice from the Center for Drug Evaluation of the National Medical Products Administration on the Release of “Frequently Asked Questions on Rapid Reporting of Safety Data During Clinical Trials of Drugs (Version 2.0)” (No. 17 of 2023)

Notice from the Center for Drug Evaluation of the National Medical Products Administration on the Release of “Frequently Asked Questions on Rapid Reporting of Safety Data During Clinical Trials of Drugs (Version 2.0)” (No. 17 of 2023)

2023-04-03

Notice from the Center for Drug Evaluation of the National Medical Products Administration on the Release of the “Guiding Principles for the Compilation, Analysis, and Reporting of Safety Information During Clinical Trials of Drugs (Trial)” (No. 16 of 2023)

Notice from the Center for Drug Evaluation of the National Medical Products Administration on the Release of the “Guiding Principles for the Compilation, Analysis, and Reporting of Safety Information During Clinical Trials of Drugs (Trial)” (No. 16 of 2023)

2023-04-03

Big News! The Center for Drug Evaluation of the National Medical Products Administration has issued the Notice (No. 6 of 2023) on the Release of the "Guiding Principles for Communication and Exchange on Supporting Drug Registration Applications with Real-World Evidence (Trial)."

Big News! The Center for Drug Evaluation of the National Medical Products Administration has issued the Notice (No. 6 of 2023) on the Release of the "Guiding Principles for Communication and Exchange on Supporting Drug Registration Applications with Real-World Evidence (Trial)."

2023-03-08

Big News! The Center for Drug Evaluation of the National Medical Products Administration has issued the Notice (No. 5 of 2023) on the Release of the "Guiding Principles for the Design and Protocol Framework of Real-World Studies on Drugs (Trial)."

Big News! The Center for Drug Evaluation of the National Medical Products Administration has issued the Notice (No. 5 of 2023) on the Release of the "Guiding Principles for the Design and Protocol Framework of Real-World Studies on Drugs (Trial)."

2023-03-08

Effective July 1, 2023! Announcement by the National Medical Products Administration on the Release of the "Special Provisions for the Registration and Management of Traditional Chinese Medicine" (No. 20 of 2023)

Effective July 1, 2023! Announcement by the National Medical Products Administration on the Release of the "Special Provisions for the Registration and Management of Traditional Chinese Medicine" (No. 20 of 2023)

2023-02-10

Notice from the Center for Drug Evaluation of the National Medical Products Administration on the Release of the “Guiding Principles for Blinding in Clinical Trials of Drugs (Trial)” (No. 49 of 2022)

Notice from the Center for Drug Evaluation of the National Medical Products Administration on the Release of the “Guiding Principles for Blinding in Clinical Trials of Drugs (Trial)” (No. 49 of 2022)

2023-01-05

To provide applicants with guidance on the proper design and implementation of blinding in clinical trials, the Center for Drug Evaluation, under the guidance of the National Medical Products Administration, has organized the development of the “Guiding Principles for Blinding in Clinical Trials of Drugs (Trial)” (see attachment). In accordance with the requirements of the “Notice from the Comprehensive Division of the NMPA on Issuing Procedures for the Publication of Pharmaceutical Technical Guidance Principles” (NMPA Comprehensive Drug Administration [2020] No. 9), and following review and approval by the National Medical Products Administration, these principles are hereby promulgated and shall take effect as of the date of their publication.

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