What are the benefits for pharmaceutical companies to be approved by the FDA?

All drug manufacturing facilities that are expected to be used for the diagnosis, relief, treatment, or prevention of disease have pharmacological activity or other direct effects, or that affect the function and structure of the body, must register with the FDA and declare all of their ingredients. All non-U.S. facilities that export drugs to the U.S. are required to register their facilities with the U.S. FDA and declare their products. This is actually not certification, and the FDA itself does not have a certification statement, but a registration record.

If you do not have FDA registration and do not obtain a registration number and ingredient declaration number (NDC), you will not be able to pass the customs inspection, and the goods will not be able to enter the U.S. market for sale, and will be denied entry by the customs. After confirming that the safety of the ingredients, the quality of the goods, and the outer packaging of the product meet the requirements, you can export pharmaceutical products to the United States with a valid registration. Thereafter, FDA may inspect the validity, compliance, and even testing of the goods at the time of customs declaration to ensure that they meet the regulatory requirements of the United States; The company's quality system documents will also be checked by email; If the inspection fails, it is likely to refuse the entry of the company's products into the United States, and even require the company to recall its products, pull the company into the blacklist, etc.

However, if the company has passed the registration and inspection of the FDA, not only can its registration information be publicly queried by customers all over the world on the FDA's official website, but also because of the authority of the FDA's own regulations, the product will also be trusted in other countries. If the company's quality system passes the FDA's on-site inspection, the FDA will issue an inspection report indicating that the factory has passed the FDA inspection, which is a recognition of the company's quality system and will be a great selling point.

Look at what kind of pharmaceutical company, if it is a traditional Chinese medicine company, it seems that there is no traditional Chinese medicine certified by the FDA.

Traditional Chinese medicine companies have passed FDA certification, and the products that have passed the certification in the future are sold in the US and even European markets. From the enterprise side, it will become the first Chinese medicine company to land in the U.S. market, which will have a great impact on the significance of the enterprise and the enhancement of brand value. Then, from the aspect of society and greater significance, it not only has a great impact on the development of Chinese traditional medicine, but also has a great help to the acceptance of traditional Chinese medicine and Chinese culture in Europe and the United States.

1. The FDA's "recognition" effect.

Obtaining FDA certification, which is recognized by the World Health Organization as the highest safety standard, means that your product will greatly enhance the trust of consumers, which will effectively enhance the credibility and brand image of the company, and thus promote the Chinese industry to align with international standards.

2. The "passport" of the U.S. market

When the product passes through the customs, it needs to be tested, especially food, medicine, cosmetics, laser and other physical contact products, if not, they cannot be passed, and FDA certification can successfully pass the customs inspection, enter the US market for sale, and be recognized by the local market.

3. The United States relies on imports of pharmaceutical materials.

Many products in the United States rely on imports, especially drug importers, about 40% of drugs rely on imports, of which 80% of the APIs used as preparations come from overseas markets, accounting for 1 3 of the world's drug market. For China, as a major country of APIs and generic drugs, the development potential of the U.S. product market has greatly attracted Chinese enterprises with the strength to enter the international market.

In addition, the United States is the world's largest medical device market, accounting for nearly half of the global medical device market. China has the world's largest medical device production scale and the largest variety of medical devices, especially in bulk medical accessories, surgical instruments, medical appliances, medical polymer consumables and other value-added products have obvious advantages: complete varieties, cheap, reliable quality, which has formed an obvious complementary advantage with the United States.

4. Enhance the competitiveness of Chinese export enterprises.

At present, more and more Chinese companies attach enough importance to the US FDA certification, because these companies believe that the food, products, cosmetics and medical devices and other products that have passed the US FDA certification are recognized by the world as the safest and most reputable.

Especially in recent years, China's food, products, medical devices and other frequent safety problems, 315 and the first blacklist enterprises, then obtain the international top FDA certification, become the company's products in the marketing of more likely to win. The U.S. medical innovation company pointed out that the financing ability of FDA-certified companies will also be enhanced, and enterprises can have more bargaining chips in business negotiations such as loans and financing.

The good thing is that your goods can enter the United States, be sold, and used.