Food and Drug Administration implements on-site inspection and management regulations for drug registration

As a normative document for the new "Drug Registration Regulations" revised in 2007, the State Food and Drug Administration (SFDA) issued the "Administrative Regulations on the Registration of Drug Registration Sites" (hereinafter referred to as "Regulations") on June 3. The purpose is to further standardize the order of drug development, strengthen the on-site verification of drug registration, and ensure the quality of inspections.
It is understood that the "Regulations" are divided into 7 chapters and 59 articles, including 5 annexes, which provide specific stipulations for on-site verification of administrative subjects, work processes, forms of documents and forms, and check points, and further authoritative interpretation of the new "Drug Registration Regulations". The relevant provisions in the article have refined and clarified the requirements for on-site verification of drug registration. Its core task is to confirm the authenticity, accuracy and completeness of the application. According to the person in charge of the SFDA, the "Regulations" will ensure that the on-site inspection of drugs will be conducted in a lawful, orderly, standardized, and efficient manner from four aspects: legal content, clear procedures, unified standards, and clear division of labor.
The “Regulations” will be divided into four phases: pre-clinical research site verification, clinical trial site verification, declaration of production and development site verification, and production site inspection. Detailed regulations will be provided for the implementation entity, procedures, materials, and sample transfer of each phase. , to ensure the operability of the inspection work. In terms of verification nature, it is divided into routine verification and verification. To this end, the “Regulations” established the key points and principles for the verification of drug registration on the spot. The relevant verification items were listed in many aspects such as pharmacy, pharmacology and toxicology, clinical trials and mass production processes, prompting key links and key elements for on-site verification. Ensure the harmonization of verification standards. At the same time, clinical trials of generic drugs and supplementary applications are included in the scope of verification.
The “Regulations” also further clarified the administrative enforcement body of the on-site inspection work, and clearly defined the responsibilities of the SFDA, the Drug Certification Management Center, the Drug Evaluation Center, the Provincial Food and Drug Administration and other departments and units.

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