According to the website of the State Food and Drug Administration, in order to standardize the order of drug development and strengthen the registration of drug registration sites to ensure the quality of inspections, on June 3, the State Food and Drug Administration issued the Regulations on the Administration of On-site Verification of Drug Registration (hereinafter referred to as “ Regulations)).
As a normative document matching the "Drug Registration Regulations" revised in 2007, the "Regulations" provide specific stipulations for the on-site verification of administrative subjects, work processes, forms of documents and forms, and check points, further explaining and explaining The relevant provisions of the new Drug Registration Administrative Measures have refined and clarified the requirements for on-site verification of drug registration, ensured the authenticity, scientificity, and standardization of the application materials and samples from the system, and ensured the drug at the source. The security is a concrete realization of the scientific concept of "re-approval and strong supervision."
The "Regulations" are divided into 7 chapters, 59 articles, and 5 attachments. The "Regulations" closely centered on the relevant requirements of the "Registration of Drugs Administrative Measures" on the registration of drug registration sites, and confirmed the authenticity, accuracy, and completeness of the application materials as the core task, and made every effort to ensure that the on-site inspection of drugs is legal and orderly from four aspects. , standardized and efficient development:
Content is legal - strictly follow the "drug registration management measures" on drug registration and development site inspection and production site inspection requirements, maintain consistency with the "Drug Registration Administration" to ensure that the "provisions" set the content and procedures are legal.
The procedure is clear--The “Regulations†divide the verification into four phases: pre-clinical research site verification, clinical trial site verification, declaration of production and development site verification, and production site inspection. The implementation subjects, procedures, materials, and samples for each phase The handover has made detailed provisions to ensure the operability of the verification work.
Standards and Unity - The "Regulations" set up the key points and principles for the verification of drug registration at the scene, listing relevant verification items from the four aspects of pharmacy, pharmacology and toxicology, clinical trials, and mass production processes, prompting key links and keys for on-site verification. The elements clearly define the principle of on-site verification, ensure the unification of verification standards, and ensure the quality of drug registration site verification.
Clear division of labor - The "Regulations" further clarifies the main body of on-site verification work execution, and perform duties for various departments and units such as the State Food and Drug Administration, Drug Certification and Management Center, Drug Evaluation Center, and Provincial Food and Drug Administration. Clearly defined. Integration of drug registration management resources, clear work responsibilities of various departments, strengthen awareness of responsibilities, strengthen coordination and cooperation, and establish an on-site inspection system that is efficient, standardized, scientific, and rigorous.
In addition, the “Regulations†also include the clinical trials of generic drugs and supplementary applications into the scope of verification, reflecting the whole concept of supervision.
Since May 2007, the State Food and Drug Administration has started the drafting of the “Regulationsâ€, and has publicly solicited opinions on the Internet in September 2007 and February 2008 respectively. Reasonable suggestions and opinions are included in the articles. Made corresponding changes.
As a normative document matching the "Drug Registration Regulations" revised in 2007, the "Regulations" provide specific stipulations for the on-site verification of administrative subjects, work processes, forms of documents and forms, and check points, further explaining and explaining The relevant provisions of the new Drug Registration Administrative Measures have refined and clarified the requirements for on-site verification of drug registration, ensured the authenticity, scientificity, and standardization of the application materials and samples from the system, and ensured the drug at the source. The security is a concrete realization of the scientific concept of "re-approval and strong supervision."
The "Regulations" are divided into 7 chapters, 59 articles, and 5 attachments. The "Regulations" closely centered on the relevant requirements of the "Registration of Drugs Administrative Measures" on the registration of drug registration sites, and confirmed the authenticity, accuracy, and completeness of the application materials as the core task, and made every effort to ensure that the on-site inspection of drugs is legal and orderly from four aspects. , standardized and efficient development:
Content is legal - strictly follow the "drug registration management measures" on drug registration and development site inspection and production site inspection requirements, maintain consistency with the "Drug Registration Administration" to ensure that the "provisions" set the content and procedures are legal.
The procedure is clear--The “Regulations†divide the verification into four phases: pre-clinical research site verification, clinical trial site verification, declaration of production and development site verification, and production site inspection. The implementation subjects, procedures, materials, and samples for each phase The handover has made detailed provisions to ensure the operability of the verification work.
Standards and Unity - The "Regulations" set up the key points and principles for the verification of drug registration at the scene, listing relevant verification items from the four aspects of pharmacy, pharmacology and toxicology, clinical trials, and mass production processes, prompting key links and keys for on-site verification. The elements clearly define the principle of on-site verification, ensure the unification of verification standards, and ensure the quality of drug registration site verification.
Clear division of labor - The "Regulations" further clarifies the main body of on-site verification work execution, and perform duties for various departments and units such as the State Food and Drug Administration, Drug Certification and Management Center, Drug Evaluation Center, and Provincial Food and Drug Administration. Clearly defined. Integration of drug registration management resources, clear work responsibilities of various departments, strengthen awareness of responsibilities, strengthen coordination and cooperation, and establish an on-site inspection system that is efficient, standardized, scientific, and rigorous.
In addition, the “Regulations†also include the clinical trials of generic drugs and supplementary applications into the scope of verification, reflecting the whole concept of supervision.
Since May 2007, the State Food and Drug Administration has started the drafting of the “Regulationsâ€, and has publicly solicited opinions on the Internet in September 2007 and February 2008 respectively. Reasonable suggestions and opinions are included in the articles. Made corresponding changes.