PHDS HEALTHCARE RESEARCH Co., Ltd.
The National Medical Products Administration will improve the management of drug registration.
Release time:
2014-08-13
The National Medical Products Administration will improve the management of drug registration (2014)
The National Medical Products Administration will improve drug registration management (2014)
The National Medical Products Administration (hereinafter referred to as "NMPA") requires its 16 subordinate agencies to provide feedback on the "Notice on Strengthening Drug Registration Management and Further Clarifying Acceptance Work Requirements," which shows some positive signals. The NMPA is expected to improve drug registration management.
Regarding new drug registration, the "Notice" stipulates: for the registration of domestic and imported drugs, clinical registration applications must be submitted first according to procedures, and after approval, a market registration application can be submitted; however, common or specific immunoglobulin for muscle injection, human albumin products, compound electrolyte injection solutions, and blood volume expanders can directly submit market registration applications; registration applications for varieties with the same active ingredients will no longer be accepted from the date the new drug enters the monitoring period; those that have been approved for clinical trials can accept market registration applications; for registration applications declared as chemical drugs of category 3, after approval for clinical trials, if the same variety of imported drugs is approved for market, the applicant can choose to conduct clinical trials according to chemical drugs of category 3 or conduct bioequivalence trials according to chemical drugs of category 6, and those conducting bioequivalence trials will be included in the generic drug sequence; for formulation clinical registration applications submitted according to chemical drugs of categories 1 to 4, a clinical registration application for the raw materials used should also be submitted; applications that only submit clinical registration for new drug raw materials will not be approved.
Regarding the registration application for generic drugs: for registration applications declared as chemical drugs of category 6, the first application can be submitted according to the market registration procedure, and if clinical trials can be waived after review, it can be directly approved for market. Applications for drugs with the same active ingredients and dosage forms as already marketed drugs but with different specifications will be accepted according to the generic drug procedure.
Regarding the association declaration of raw materials and formulations: when accepting formulation registration applications, the source of the raw materials should be reviewed. If the raw materials have not been approved for market (import), a copy of the acceptance notice for the raw material registration application and the acceptance number related to the associated raw materials should be provided, and the review of raw materials and formulations will be combined; if the raw materials and formulations are declared separately according to chemical drugs of categories 3 and 5, both the raw materials and formulations should apply according to the new drug clinical registration procedure for the first declaration; if the raw materials and formulations are declared separately according to chemical drugs of categories 3 and 6, the category 3 raw materials should apply according to the new drug clinical registration procedure, and if the formulation can be directly approved for market after review, the review department will notify the applicant to supplement other relevant materials required by the raw material market registration application procedure. If the formulation requires clinical trials after review, both the raw materials and formulations will be approved for clinical trials simultaneously, and after completing the clinical trials, the raw materials will be declared according to the market registration application procedure.
The NMPA has recently announced a directory of excessively repetitive drug varieties. According to the "Notice," the NMPA will limit the application of excessively repetitive drugs, which, on the other hand, protects new drugs that have been approved and entered the monitoring period.
At the same time, the "Notice" shows that the NMPA will shorten the approval time for new drugs, especially generic drugs, from a technical level. However, from the "Notice," the NMPA did not mention reforms regarding the procedures, time limits, and approval authority delegation for drug registration applications.
Keyword:
Next article
Relevant regulations and policies
Key points and judgment principles for the quality management of non-clinical research of drugs
In order to standardize the on-site inspection work of Good Laboratory Practice (GLP) for non-clinical drug research and improve inspection quality, the "Key Points and Determination Principles for the Inspection of Good Laboratory Practice in Non-Clinical Drug Research" has been formulated in accordance with relevant requirements such as the "Drug Administration Law of the People's Republic of China," "Good Laboratory Practice for Non-Clinical Drug Research," and "Management Measures for the Certification of Good Laboratory Practice for Non-Clinical Drug Research."
2024-11-22
Technical requirements for the latest declaration data electronic disc
In order to further improve the quality and efficiency of the preparation of electronic application materials for drug registration, and to standardize the management of electronic application materials, our center has updated the "Technical Requirements for Electronic Discs of Application Materials" and "Structure of Electronic Documents for Drug Registration Applications" published on December 2, 2022, based on feedback.
2024-11-22
In December 2023, PHDS HEALTHCARE RESEARCH Co., Ltd. was elected as the vice president unit of the China Food and Drug Enterprise Quality Safety Promotion Association, as well as the vice chairman of its subordinate digital professional committee (Certificate No.: Zhong Shi Yao An Cu Hui Zheng Zi 798). The election and award ceremony took place at the Three Gorges Hospital of Chongqing Medical University.
2024-11-22
On March 26-27, 2024, the China Wuxi Global Oral Forum and the China Food and Drug Promotion Association High-Quality Development Conference, guided by the Wuxi Municipal People's Government and the Wuxi Council for the Promotion of International Trade, and organized by the China Food and Drug Promotion Association and the Oral Health Committee of the China Food and Drug Promotion Association, will be grandly held at the Wuxi International Conference Center.
2024-11-22
What if you have more needs?
Leave your demand information online and we will reply to you in time!
Contact Information
Customer service hotline:
E-mail:customer@cnphds.com
Address: Building A, Ocean Express,66 Xia Guang Li, Dong San Huan North Road,Chaoyang district, Beijing, China
Mobile
Public Number
京公网安备11010502056452号