US FDA certification
The U.S. Food and Drug Administration (FDA) is referred to as FDA. FDA is the U.S. government's Department of Health and Human Services (DHHS) and Department of Public Health(PHS) One of the executive agencies established in . As a scientific regulatory agency, the FDA's responsibility is to ensure the safety of food, cosmetics, drugs, biologics, medical devices and radioactive products produced or imported into the United States. It was one of the first federal agencies whose primary function was to protect consumers.
FDA introduction and composition
This organization touches the lives of every American citizen. Internationally, the FDA is recognized as one of the largest food and drug regulatory agencies in the world. Many other countries seek and receive assistance from the FDA to promote and monitor the safety of their own products.
The Food and Drug Administration (FDA) is responsible for: food, drugs (including veterinary drugs), medical devices, food additives, cosmetics, animal food and drugs, wine beverages with an alcohol content of less than 7%, and electronics Product supervision and inspection; also includes cosmetics, radiation products, combination products and other electronic products and medical products related to personal health and safety. Testing, inspection and certification of items that affect human health and safety due to ionizing and non-ionizing radiation generated during product use or consumption. According to regulations, the above-mentioned products must be inspected and proven safe by the FDA before they can be sold on the market. FDA has the right to inspect manufacturers and prosecute violators. According to the different product scopes regulated, it can be divided into the following major regulatory agencies:
1. Center for Food Safety and Practical Nutrition (CFSAN):
This center is the department with the largest workload of FDA. It is responsible for food safety throughout the United States, except for meat, poultry and eggs, which are regulated by the USDA. Although the United States has the safest food supply in the world, approximately 76 million foodborne illnesses occur each year, and 325,000 people require hospitalization due to foodborne illness. Death from foodborne illness. The Center for Food Safety and Nutrition works to reduce foodborne illness and promote food safety. And promote various plans, such as: promotion and implementation of HACCP plan, etc.
The functions of the center include: ensuring the safety of substances and pigments added to food; ensuring the safety of food and ingredients developed through biotechnology; responsible for the correct labeling of food (such as ingredients, nutrition and health claims) ) and cosmetics management activities; formulate corresponding policies and regulations to manage dietary supplements, infant food formulas and medical foods; ensure the safety of cosmetic ingredients and products and ensure correct labeling; supervise and regulate the after-sales behavior of the food industry; carry out Consumer education and behavioral outreach; collaborative projects with state and local governments; coordination of international food standards and safety, etc.
2. Center for Drug Evaluation and Research (CDER):
The center is designed to ensure the safety and effectiveness of prescription and over-the-counter medicines, evaluate new drugs before they are launched on the market, and oversee more than 10,000 medicines on the market to ensure that products meet the highest standards that are constantly updated. . The center also regulates the truthfulness of drug advertisements on television, radio and in publications. Strictly regulate drugs and provide consumers with accurate and safe information.
3. Center for Equipment Safety and Radiation Protection Health (CDRH):
The center ensures the safety and effectiveness of newly marketed medical devices. Because there are more than 20,000 companies around the world producing more than 80,000 types of medical devices, from blood glucose monitors to artificial heart valves. These products are closely related to human life, so the center also supervises after-sales services nationwide. For some products that can produce radiation, such as microwave ovens, televisions, and mobile phones, the center has also determined some corresponding safety standards.
4. Center for Biologics Evaluation and Research (CBER):
The center regulates biological products that can prevent and treat diseases and is therefore more complex than chemically integrated drugs. It includes scientific research on the safety and effectiveness of blood, plasma, vaccines, etc.
5. Center for Veterinary Medicines (CVM):
FDA certification introduction
Food FDA certification
FDA's regulatory agency for food, agricultural products, and seafood is the Center for Food Safety and Nutrition (CFASAN), whose responsibility is to ensure that Americans' food supply is safe, clean, fresh, and clearly labeled.
The annual food imports supervised by the center are 240 billion US dollars, of which 15 billion is imported food. The center's main monitoring focuses include:
1. Food freshness; 2. Food additives; 3. Food biotoxins and other harmful ingredients; 4. Seafood safety analysis; 5. Food labeling; 6. Post-market tracking and warning of food< /p>
According to the anti-terrorism law passed by the U.S. Congress in 2003, food companies outside the United States must register with the FDA before exporting to the United States, and report shipments to the FDA when exporting.
The foreign food production and processing enterprises that must register with the FDA in accordance with "U.S. Public Law 107-188" are as follows:
1. Wine and alcoholic beverages;
2. Baby and children's food;
3. Bread and pastries;
4. Beverages;
5. Candy (including chewing gum);
6. Oatmeal and ready-to-eat cereals;
7. Cheese and cheese products;
8. Chocolate and cocoa foods;
9. Coffee and tea products;
10. Food pigments;
11. Conventional foods and medicinal foods for weight loss, and meat substitutes;
12. Supplementary foods (i.e. domestic health foods, vitamin drugs and Chinese herbal products);
13 Condiments;
14. Fish and seafood;
15 Materials, substances and products placed in food and in direct contact with food;
16, agents and safe food ingredients;
17. Food sugar substitute;
18. Fruits and fruit products;
19. Edible gum, lactase, pudding and stuffing;
20. Ice cream and related foods;
21. Imitation dairy products;
22. Macaroni and noodles;
23. Meat, meat products and poultry products;
24. Milk, butter and dry dairy products;
25. Dinner foods, marinades, sauces and specialty products;
26. Dried fruits and nuts;
27. Shell eggs and egg products;
28. Desserts (flour, meat and vegetables);
29, chili, special condiments, salt, etc.;
30. Soup;
31. Soft drinks and canned water;
32. Vegetables and vegetable products;
33. Vegetable oil (including olive oil);
34. Vegetable protein products (prepared meat products);
35. Whole wheat foods and flour-processed foods, starches, etc.;
36. Products mainly or entirely for human consumption;
Medical device FDA certification
FDA's management of medical devices is carried out through the Center for Devices and Radiological Health (CDRH), which supervises the production, packaging, and distributors of medical devices to comply with the law and conduct business activities.
Medical devices range from as small as medical gloves to as large as cardiac pacemakers, all of which are under the supervision of the FDA. Based on the medical purpose and possible harm to the human body, the FDA classifies medical devices into I , Category II, and Category III, the higher the category, the more supervision.
If the product is a novel invention that does not exist on the market, the FDA requires the manufacturer to conduct rigorous human experiments and have convincing medical and statistical evidence to demonstrate the effectiveness and safety of the product.
FDA certification of medical devices, including: manufacturer registration with FDA, product FDA registration, product marketing registration (510 form registration), product marketing review and approval (PMA review) Labels of medical and health care devices In connection with technical transformation, customs clearance, registration, and pre-market reporting, the following materials must be submitted: (1) Five copies of the fully packaged finished product, (2) Device structure diagram and its text description, (3) Device performance and working principle; 4) Safety demonstration or test materials of the device, (5) Introduction to the manufacturing process, (6) Clinical trial summary, (7) Product instructions. If the device has radioactive properties or releases radioactive materials, it must be described in detail.
Factory and product registration of medical devices
FDA has a clear and strict definition of medical devices, which is defined as follows: "Medical devices refer to instruments, devices, tools, machinery, appliances, insertion tubes, in vitro reagents and Other related articles, including components, parts or accessories: expressly listed in the National Formulary or the Unite States Pharmacopeia or in the appendices of either; intended for use in the diagnosis of animal or human disease, or other physical conditions, or for the treatment of disease Those who cure, slow down and treat; those who are expected to affect the body functions or structures of animals or humans, but do not achieve their primary purpose through metabolism."
Only products that meet the above definition can be regarded as medical devices. Under this definition, not only various instruments and tools in hospitals, but also spectacle frames and spectacle lenses that consumers can buy in general stores , toothbrushes, massagers and other fitness equipment are all within the scope of FDA management. It is slightly different from the domestic identification of medical devices.
According to different risk levels, FDA divides medical devices into three categories (I, II, III), with category III having the highest risk level. The FDA clearly stipulates its product classification and management requirements for each medical device. Currently, there are more than 1,700 types in the FDA's medical device product catalog. Any medical device that wants to enter the U.S. market must first clarify the product classification and management requirements for applying for marketing.
FDA has formulated many bills for medical devices, and has revised and supplemented them from time to time, but there are not many basic bills, mainly including: Federal Food, Drug, and Cosmetic Act (FD&C Act, basic Act); Public Health Service Act; Fair Packaging and Labeling Act; Health and Safety Radiation Control Act; Safe Medical Devices Act; Modernization Act. FDA has given very detailed explanations of these bills and has specific operational requirements. Before companies plan to enter the U.S. market, they need to carefully evaluate the regulations and specific requirements related to their products (including different U.S. product standard requirements).
After clarifying the above information, the company can prepare relevant application materials and submit them to the FDA according to certain procedures to obtain approval. For any product, the enterprise needs to carry out enterprise registration (Registration) and product listing (Listing). For Class I products (accounting for about 47%), General Control is implemented. Most products only need to be registered, listed and implemented GMP regulations, and the products can enter the U.S. market (a very few of them do not even have GMP requirements). Exemption, a very small number of reserved products need to submit a 510(K) application to the FDA (PMN (Premarket Notification)); for Class II products (accounting for about 46%), special control (Special Control) is implemented, and companies must register and After listing, you still need to implement GMP and submit 510(K) applications (very few products are 510(K) exempt); for Class III products (accounting for about 7%), pre-market licensing is implemented, and companies must register and After listing, GMP must be implemented and a PMA (Premarket Application) application must be submitted to FDA (some Class III products are still PMN).
For Class I products, after the company submits relevant information to the FDA, the FDA will only make an announcement and no relevant certificate will be issued to the company; for Class II and III devices, the company must submit a PMN or PMA, and the FDA will At the same time as the announcement, the company will be given a formal market access approval letter (Clearance), which allows the company to directly sell its products in the U.S. medical device market in its own name. As for whether to conduct on-site GMP assessment at the enterprise during the application process, the FDA will decide based on comprehensive factors such as product risk level, management requirements, and market feedback.
Based on the above, it can be seen that most products can be approved by FDA for marketing after company registration, product listing and GMP implementation, or submitting a 510(K) application.
1. The 510(K) document is the document required by the FDA for PMN. Because it corresponds to Chapter 510 of the FD&C Act, it is usually called the 510(K) document.
2. Substantial Equality Comparison (SE)
3.510(K) Review Procedure
Before applying, it is necessary to clarify whether the product is recognized by the FDA as a medical device, product category, management requirements, and clarify the application work content;
Check whether the product applied for listing has US mandatory standards and whether the product meets the standards (a formal inspection report from a testing agency is generally required);
Before preparing 510(K) application documents, you need to consider whether you really need to submit it, when to submit it, and what type of 510(K) application to submit: regular 510(K), special 510( K), simplify 510(K);
Written and timely answers to questions raised by FDA during the application process should be provided in a timely manner;
The paper size of all information submitted to FDA should be Letter Size (21.5cm X29.7cm);
Enterprises must keep backup copies of all information submitted to the FDA, because the FDA electronically scans and logs in the application information after receiving it, destroys the application information at the same time, and does not return it to the enterprise.
For a small number of products, FDA will conduct on-site GMP assessments of enterprises. Enterprises must refer to US GMP management requirements and provide appropriate translators who have a certain understanding of GMP and enterprises during FDA on-site audits. ;
The formal contact person notifying the FDA needs to have a certain understanding of FDA regulations and working procedures, and be able to communicate directly with the FDA to facilitate timely feedback. The company can clarify that it or entrust a consulting agency to be responsible for communicating with the FDA. Daily communication.
Cosmetics FDA certification
Cosmetics Voluntary Registration Program (VCRP)
FDA's Office of Cosmetics and Colors has developed a voluntary registration program for cosmetics at the request of the cosmetics industry. The plan consists of two parts: voluntary registration of cosmetics manufacturers and declaration of cosmetic ingredients.
Benefits of participating in VCRP
Voluntary registration by a manufacturer and obtaining a registration number does not mean that FDA approves the manufacturer or its products, and FDA does not allow manufacturers to use the registration number or listing number obtained by participating in VCRP for commercial promotion; however, Manufacturers can directly obtain the following benefits by participating in VCRP:
Get important information about cosmetic ingredients. FDA enters all information obtained from the VCRP into a computer database. If a currently used cosmetic ingredient is considered harmful and should be banned, the FDA will notify the manufacturer or seller of the product through the address book in the VCRP database. If your product is not in the registration database, the FDA will not be able to notify you.
Avoid product recalls or product detention during import due to ingredient issues. If a cosmetics manufacturer files its product formula in VCRP, if the FDA finds that the manufacturer has used unapproved color additives or other prohibited ingredients in the formula, it will alert the manufacturer. In this way, manufacturers can modify the product formula before the product is imported or sold, thereby eliminating the risk of product recalls or detentions due to the use of inappropriate ingredients. Help retailers identify safety-conscious manufacturers. Retailers (such as department stores) sometimes ask the FDA whether a certain cosmetics company is registered with the FDA. Although registration does not indicate FDA approval, it does indicate that your product has been reviewed by the FDA and entered into the government's database. If the product formula you submit is incomplete or contains a prohibited ingredient or unapproved color additive, the FDA will notify you.
The decision to collect samples is based on the nature of the product; FDA's focus issues; and the past history of the product. FDA obtains a physical sample and sends it to an FDA regional laboratory for analysis
If the FDA finds that the sample meets the requirements, it will send a "release notice" to the US Customs and the importer respectively.
If the FDA determines that the sample "violates the FDCA and other relevant laws", it will send a "Notice of Seizure and Hearing" to the U.S. Customs and the case and the importer respectively. The notification details the violation and nature and gives the case and the importer 10 working days to provide evidence that the shipment can be approved.
The seized imported goods must be repaired, reintroduced or destroyed under the supervision of FDA or US Customs
The hearing is the importer's only opportunity to defend the imported goods or to provide evidence that the goods will be suitable for entry after being repaired.
If the case and consignor, cargo owner, importer or a designated representative do not respond to the notification, FDA will send a "Notice of Denial" to the US Customs and the case and importer. The products in question are then returned or destroyed.
If the case and underwriter, cargo owner, importer or a designated representative respond to the "Notice of Seizure and Hearing", when the importer provides evidence that the product "complies with the requirements" or submits for repairs When a product application is filed, FDA holds a hearing on the seized product.
If the trader provides evidence that the product meets the requirements, FDA will collect subsequent samples. Pending analysis, the product will either be released or refused entry.
FDA reviews the importer's proposed modification procedures and approves or disapproves them as appropriate. Once approved, FDA will conduct subsequent inspection/sample collection to determine eligibility. If the sample is qualified, a "release notice" will be sent to US Customs and the importer. If the fruit sample is unqualified, a "notice of rejection" will be issued.
Section 8(C) of the FDCA requires applicants to pay all costs, except for the cost of updating labels or other measures to bring seized merchandise into compliance with the terms of the application (Form FDA-766). Travel, daily expenses, and wages for FDA officials or employees. By submitting Form FDA-766, the applicant agrees to pay all regulatory fees in accordance with current regulations.
Drug FDA certification
FDA has a complete set of certification procedures for pharmaceutical products to ensure the safety and effectiveness of new drugs. The procedures are as follows:
1. Investigational New Drug Review Application (IND):
When a pharmaceutical company submits an IND to the FDA, FDA's monitoring of the new drug begins. At this time, human trials of the new drug have not yet begun. The FDA mainly reviews in vitro safety data and animal experimental data to determine whether the drug is adequate. Safely enter the human experiment stage.
2. Human experiment:
Human experiments are divided into 4 stages. The first stage mainly tests the safety of the drug, main side effects, metabolic mechanism, etc., the number of samples is generally less than 00.
The second phase mainly tests the effectiveness of the drug, to determine whether the drug can effectively act on the human body. At the same time, the safety and side effects of the drug are also the objects of close observation. II The number of samples in a period experiment is generally less than 300.
If the Phase 2 experiment is encouraging, a larger sample will be ready for testing, the experiment will move into Phase 3. Phase 3 will include different age groups, different populations, ;With different dosages of drugs, to comprehensively study the safety and effectiveness of the drugs. The number of samples in the third phase of the trial ranges from hundreds to thousands.
The fourth phase is mainly conducted after the approval of a new drug, it mainly tests the long-term safety of the drug, new populations, etc.
3. New Drug Application (NDA):
When a pharmaceutical company completes human experiments and verifies the safety and effectiveness of a new drug, formally submits an NDA application to the FDA. The FDA reviews all animal and human experimental data, as well as the drug's metabolism mechanism Data, GMP data for drug production, if the data is incomplete or unreasonable, FDA will reject the application, otherwise FDA will complete the application in about 10 months and give an approval or rejection opinion.
The above content is excerpted from the "MTG FDA Certification Service Center Service Manual"
FDA certification process
1. Preparation Phase
Copy of corporate legal person license;
Production (sanitation) license, copy of certificate;
Company profile (establishment time, technical strength, main products and performance, asset status).
2. Technical preliminary review application acceptance
Submit the English translation of DMF (Drug Master File) and SOP (Standard Operating Procedure) to the agent;
The above documents will be modified based on the agent's opinions.
3. DMF data review
FDA carefully reviews and conducts on-site inspections of factories to check whether what is written in the DMF document is true;
If the FDA finds no major errors and believes it meets the requirements, it will propose a pre-approval inspection plan.
4. FDA inspection
FDA inspectors inspect the factory and ask questions, and the factory must answer them one by one;
If there is any doubt, the official will issue a "483" form (rectification proposal). If the problem is serious, the "483" form will not be issued.
5. FDA issues "Letter of Approval";
Must answer carefully the questions raised by the inspector on the "483" form. If there are any questions, they must be corrected and certified immediately;
Questions that the prosecutor does not understand need explanation and proof
FDA certification for food contact products and materials
Food contact materials refer to all materials that can come into contact with food during processing, production, packaging, storage and transportation. Common materials include various plastics, metals, ceramics, glass, bamboo and wood products, etc., which are closely related to food The environmental protection and safety of accessible materials is directly related to the food safety and health of users, so exports of such products to the United States require relevant testing and certification in accordance with FDA standards
Common FDA certification testing items for food contact materials are as follows:
Organic coatings, Metal and electroplated products requirements U.S. FDA CFR 21 175.300.
water extractives Deionized water leaching method
8% alcohol extractives 8% alcohol extraction method
n-heptane extractives n-heptane leaching method
Paper product requirements U.S. FDA CFR 21 176.170
Net chloro soluble extractives for water fraction Chloroform soluble extractives (deionized water leaching method).
Net chloro soluble extractives for 8 % alcohol fraction Chloroform soluble extractives (8% alcohol extraction method)
Net chloro soluble extractives for 50 % alcohol fraction Chloroform soluble extractives (50% alcohol extraction method)
Net chloro soluble extractives for n-heptane fraction Chloroform soluble extractives (n-heptane leaching method)
Wood requirements U.S. FDA CFR 21 178.3800
Pentachlorophenol and its salt Pentachlorophenol PCP
ABS requires U.S. FDA CFR 21 181.32 or 180.22.
in water Deionized water leaching method
in 3% acetic acid 3% acetic acid leaching method
in 8% ethanol 8% alcohol extraction method
in n-heptane n-heptane leaching method
FDA product certification application process
1. The importer or agent submits a declaration form to the customs at the port of entry within five days of the arrival of the goods;
2. The Food and Drug Administration learns about the entry of regulated foods through the following channels
． Copy of customs entry declaration (CF 3461, CF 3461ALT, CF 7501 or its replacement)
． Copy of commercial invoice
． Liability, tax and penalty protection guaranteed.
3. The Food and Drug Administration reviews the importer's entry declaration form to determine whether physical inspection, terminal inspection or random inspection is required.
4A. Decide not to do random inspections. The Food and Drug Administration issued a letter to the U.S. Customs and the importer who made the application saying "it can proceed." As far as the FDA is concerned, the shipment is released.
4B. Decide to conduct random inspections based on the following items:
． Nature of the goods;
． Food and Drug Administration priorities, and the history of the product.
The Food and Drug Administration issued a "sampling notice" to the U.S. Customs and the importer. The shipment must remain intact until further notice. After sampling, the importer can move the goods to other terminals or warehouses (please contact U.S. Customs for details).
5. The Food and Drug Administration obtains physical samples. The samples are sent to the Food and Drug Administration district laboratory for testing and analysis.
6A. After analysis, the Food and Drug Administration confirms that the sample meets the requirements, and the Food and Drug Administration issues a "notification" to the U.S. Customs and importers.
6B. The Food and Drug Administration analyzed and determined that the sample "appears to violate the FD&C Act and other relevant laws." The Food and Drug Administration issues a "Notice of Detention and Hearing" to U.S. Customs and the importer. The notice explains the nature of the violation and gives the importer ten working days to state the reasons why the goods can be accepted.
This hearing is the importer’s only opportunity to defend the import and/or provide evidence for legal entry.
7A. The consignee, actual owner of the cargo, importer or its designated representative responds to the "Notice of Detention and Hearing". Give oral or written testimony as to whether the shipment is acceptable.
7B. The consignee, actual owner of the cargo, importer or its designated representative neither responds to the "Notice of Detention and Hearing" nor requests an extension of the hearing period.
8A, the Food and Drug Administration holds a hearing on whether the product is acceptable. This hearing is an opportunity to state relevant matters and is limited to providing relevant evidence.
8B. The Food and Drug Administration issues a "Rejection of Entry" notice to the importer. This is the same person or company to whom the "Sampling Notice" was issued. All persons who receive a "Notice of Sampling" and a "Notice of Detention and Hearing" are issued a "Notice of Denial".
9A. The importer provides evidence to prove that the product meets the requirements. Provide sampling results tested by reliable laboratories that meet published standards for "contaminants and defects in human food."
9B. The importer submits an application for "authorization to improve or take other measures (FDAFD766 form)". The schedule requires that adulterated or misbranded food be permitted to be brought into conformity by relabeling or other measures, or to be converted into a non-utilitarian article. Specific methods must be proposed to make the food comply with the requirements.
9C. The Food and Drug Administration receives approval from the U.S. Customs to export or destroy the goods. The export or destruction of the goods listed on the "Rejection Notice" will be carried out under the guidance of U.S. Customs.
10A. The Food and Drug Administration collects processed food samples to determine whether they meet the standards.
10B. The Food and Drug Administration reviews the improvement procedures proposed by the importer. Compensation for liquidation losses requires a contract.
11A, the Food and Drug Administration certified the sample as "qualified". Issue a "Release Notice" to the U.S. Customs and Importers with the words "Originally detained, now released."
11B. The Food and Drug Administration deemed the sample "unqualified". The importer can submit an application for "Authorization to Improve or Take Other Measures" (see 9B), otherwise, the Food and Drug Administration will issue a "Notification of Rejection" (see 8B).
11C, Food and Drug Administration approves importer’s improvement procedures. The approved application letter is awaiting release notice from the Food and Drug Administration, and the product must remain as it is" statement.
11D. If past experience shows that the proposed method will not be successful, the Food and Drug Administration will reject the applicant's improvement process. The FDA will not consider the second and final request unless it proposes meaningful improvements in implementation to ensure a reasonable likelihood of success. Applicants are notified on FDA Form FD 766.
12. The importer has completed all improvement procedures and notified the Food and Drug Administration that the goods are ready for inspection or sampling.
13. The Food and Drug Administration will conduct subsequent inspections and sampling to determine whether it meets the terms of the improvement authorization.
14A, Food and Drug Administration analysis determined that the sample was qualified. Issue a "release notice" to the importer and US Customs. Food and Drug Administration regulatory fees are estimated in FDA Form FD790. Send a copy to US Customs. U.S. Customs is responsible for collecting the total fee, including fees required by customs officers.
14B, the Food and Drug Administration determined that the sample was still unqualified. Food and Drug Administration regulatory fees are estimated in FDA Form FD790. U.S. Customs is responsible for collecting the total fee, including fees required by customs officers. .
Importers can speed up the entry of goods!
． Make sure the product to be imported is legal before shipment.
． Ask private laboratories to test samples of food products to be imported and verify analyzes of processing plants. Although these analyzes are not final, they may indicate the processing plant's ability to produce satisfactory and legal products.
． Before signing a shipping contract, familiarize yourself with the legal requirements of the Food and Drug Administration.
． Request assistance from the FDA regional office responsible for your port of entry.
． Be familiar with the food import procedures described in this article.
Development of FDA in my country
Some experts pointed out that after the establishment of the State Food and Drug Administration, the regulatory functions of multiple original agencies must be integrated and all regulations must be integrated. Enterprises believe that the integration of food and drug supervision is detrimental to enterprises. There is no doubt that the impact on food companies in particular will prompt a reshuffle of the food industry. On March 10, 2003, the State Council's institutional reform plan was officially released, and the State Food and Drug Administration will be officially listed soon. It is understood that its "three determinations" (defining functions, determining staffing, and determining institutions) are being stepped up. In 2003, the topic of institutional reform was a hot topic in major media. Before the details are clear, people are making various speculations and assumptions, and the departments and companies involved are waiting.
The State Food and Drug Administration was established on the basis of the former State Food and Drug Administration to strengthen food safety supervision. It is mainly responsible for the comprehensive supervision and organization and coordination of the safety management of food, health products and cosmetics, and investigates and handles major accidents in accordance with the law. It can be seen that the country has placed food safety issues in an important position.
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