The FDA filing can explain the following aspects.
First of all, the FDA filing can prove that the drug or medical device has passed the relevant approval procedures and has been approved by the drug administration. This means that the product meets the requirements of national laws and regulations and is qualified for marketing.
Secondly, the FDA record can also show that the production, quality control, sales and other aspects of the product has been reviewed and recognized by the regulatory authorities. This includes the production process, quality standards, quality control system and other aspects of the requirements to ensure that the product's safety, effectiveness and quality reliability. In addition, the FDA filing can also reflect that the manufacturer or distributor of the product has the appropriate qualifications and operating conditions. During the filing process, the Drug Administration will audit the production facilities, personnel qualifications, quality management system, etc. of the enterprise to ensure that it has the ability and conditions to produce and sell the relevant products.
Finally, the FDA filing can also provide some protection for consumers.
When the filed products are sold in the market, consumers can inquire about the relevant filed information to understand the product's manufacturer, product approval number, expiration date and other important information, in order to make a safe and reasonable purchasing decision. FDA filing refers to the declaration and approval of drug manufacturers, business enterprises or medical institutions to the Drug Administration to ensure that their production and operation activities are in compliance with laws and regulations. The importance of FDA filing cannot be ignored. First of all, the FDA filing is an important means to ensure the safety of public medication, through the filing process, the production, circulation and use of drugs can be regulated to reduce the inflow of counterfeit and shoddy drugs into the market, and to protect the public's health. Secondly, FDA filing is a guarantee to improve the quality of drugs. The filing process will audit the drug manufacturers to ensure that they meet the requirements of GMP (Good Manufacturing Practice) and improve the quality standard of drugs. In addition, FDA filing can also enhance the credibility of the enterprise, and obtaining the filing certificate can improve the image and competitiveness of the enterprise. In short, the FDA filing has an important impact on safeguarding public drug safety, improving drug quality and promoting enterprise development.
Summary: FDA record can show that drugs, medical devices and other products have gone through the relevant approval and regulatory procedures before being listed on the market, have the qualification of being listed on the market, and the production, quality control, sales and other aspects of the national requirements. The record information also provides consumers with a certain degree of product information transparency and protection.
Legal basis:
"Chinese People's **** and State Drug Administration Law"
Article 52
Engaged in pharmaceutical business activities shall have the following conditions:
(a) a pharmacist or other pharmacy technicians qualified according to the law;
(b) a place of business appropriate to the drugs being operated, equipment, warehousing facilities and sanitary environment;
(3) have quality management institutions or personnel appropriate to the operation of drugs;
(4) have regulations to ensure the quality of medicines, and in line with the requirements of the State Council's drug supervision and management department in accordance with the requirements of the Drug Administration's standardization of the quality of drug business management.
Article 64
Drugs shall be imported from the ports that allow the importation of drugs, and the enterprise importing the drugs shall file a record with the drug supervision and administration department where the port is located. Customs with the drug supervision and management department issued by the customs clearance of imported drugs for customs clearance procedures. No imported drugs without customs clearance, the customs shall not be released.
The port where the drug supervision and management department shall notify the drug testing organization in accordance with the provisions of the State Council drug supervision and management department of the imported drugs for sampling and testing.
Allow the port of importation of drugs by the State Council Drug Administration in conjunction with the General Administration of Customs proposed for approval by the State Council.