The reporter learned from a recent press conference that the process of reviewing and approving drug re-registration is currently in full progress. This initiative is part of a broader effort to ensure drug safety, quality, and compliance with national regulations. According to Article 42 of the "Regulations on the Implementation of the Drug Administration Law," drug approval numbers issued by the State Council's drug regulatory authority, as well as the "Import Drug Registration Certificate" and the "Pharmaceutical Product Registration Certificate," are valid for five years. If a manufacturer intends to continue producing or importing the drug, they must apply for re-registration six months before the expiration date. During this process, relevant information must be submitted according to the guidelines set by the drug regulatory authority. Re-registration serves as a key means of ongoing supervision and reflects the statutory responsibilities of food and drug regulatory agencies. Although drug re-registration is considered a routine part of the registration management system, it has taken on special significance under the National Action Plan for Rectifying and Regulating the Drug Market Order. This means that during re-registration, authorities will closely examine the drug’s approval number, production process, and formula. This process can be viewed as an extension and deepening of previous regulatory efforts aimed at improving market order and ensuring product safety. In August of this year, the Food and Drug Administration released the "Notice on Doing a Good Job in the Examination and Approval of Drug Re-registration," which outlined specific "Review Points for Drug Re-registration" and launched the formal examination and approval process. Drug re-registration involves evaluating whether the applicant meets the conditions for re-registration, whether the manufacturer has fulfilled its legal obligations, and whether the drug meets the requirements for continued approval. In theory, if all required work is completed within the validity period of the approval document and no major issues have arisen, the drug should be eligible for re-registration. However, if the re-registration criteria are not met, the approval number will not be renewed, and it will be canceled after the expiration date. To ensure consistency and clarity, the re-registration process has established 12 specific review points, each of which must be satisfied for a drug to be re-registered. Failure to meet any one of these points results in rejection. Through this process, drugs that lack proper manufacturing conditions, fail to meet quality standards, or pose significant safety risks will be removed from the market. As per the new requirements, all drug varieties with expired approval documents must complete re-registration by September 30 of next year. Any drug that does not receive re-registration approval will no longer be allowed to be sold. The provincial drug regulatory authorities are primarily responsible for carrying out this task. This initiative marks a critical step in strengthening drug regulation and protecting public health. It reflects a growing emphasis on transparency, accountability, and long-term oversight in the pharmaceutical industry.

Magnetic Bead Nucleic Acid Extraction Reagent

The magnetic bead method nucleic acid extraction kit is a high-tech product that combines biological science and nanomaterial science. It is a major breakthrough in my country's nucleic acid extraction and purification technology. . Magnetic bead method for nucleic acid extraction has incomparable advantages over traditional DNA extraction methods, which are mainly reflected in: 1. It can realize automatic and large-scale operation. At present, there are 96-well nucleic acid automatic extraction instruments, and the extraction time of one sample can be realized. The processing of 96 samples complies with the high-throughput operation requirements of biology, enabling rapid and timely response to infectious disease outbreaks, which makes traditional methods unmatched; â‘¡ The operation is simple and time-consuming, and the entire extraction process has only four steps , most of them can be completed within 36-40 minutes; â‘¢ Safe and non-toxic, no toxic reagents such as benzene and chloroform in traditional methods are used, and the damage to experimental operators is minimized, which fully conforms to modern environmental protection concepts; â‘£ Magnetic beads and nucleic acids The specific binding of the extracted nucleic acid results in high purity and high concentration of the extracted nucleic acid. According to the same principle as the silica membrane spin column, the superparamagnetic silica nano-magnetic beads are prepared after the surface of the superparamagnetic nanoparticles is modified and modified by nanotechnology. The magnetic beads can specifically recognize and efficiently bind to nucleic acid molecules on a microscopic interface. Using the superparamagnetic properties of silica-coated nanomagnetic microspheres, under the action of Chaotropic salts (guanidine hydrochloride, guanidine isothiocyanate, etc.) and an external magnetic field, samples from blood, animal tissues, food, pathogenic microorganisms, etc. The isolated DNA and RNA can be used in clinical disease diagnosis, blood transfusion safety, forensic identification, environmental microbial testing, food safety testing, molecular biology research and other fields. Magnetic bead nucleic acid extraction can generally be divided into four steps: lysis-binding-washing-elution. Genetic testing will surely become a new symbol of the development of the biological industry. The emergence of high-throughput, automated nucleic acid extraction methods will reduce the labor cost of genetic testing, make large-scale testing a reality, and make it possible for genetic testing to reach ordinary people.

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