Is it necessary for domestic pharmaceutical enterprises to pass FDA certification?

[China Pharmaceutical network industry trends] according to the industry, at present, many pharmaceutical enterprises in China are small in scale, low in profit and weak in production capacity There is no U.S market at all, or the U.S market is very small, and the cost of GMP maintenance of the factory itself is far greater than the profit in the U.S market So, is it necessary for domestic enterprises to have FDA certification? Of course, the quality should be improved, but is it necessary to pass the FDA certification in order to improve the product quality? After the certification of domestic products will have how much impact? The author in a forum to see the question, people have different views "70% of products go to the United States, you can't say that?" "Does the curve save the country? Let's not talk about the export, but the domestic sales help is quite obvious You can't say that? " "Drugs should be internationalized At present, in the pharmaceutical industry, we have to admit that some technologies are not as good as those in Europe and the United States, and some norms and requirements are not strict enough We look forward to the internationalization of China's pharmaceutical market and then the steady growth, and surpassing the international level to become the leader of the pharmaceutical market "
…… These are the views of the supporters "However, it's not allowed to enter the other side's market It's so simple and straightforward," said netizens who supported the FDA certification Relevant people added that after the enterprise passed the FDA certification, diffraction effect also exists in other markets, making it easier to sell products Other netizens said, "sometimes you may not be able to enter the other side's market after a while, but you can improve your competitiveness." In this regard, the relevant people raise questions: in addition to coercion, is the quality of drugs not what our people want? The opposite side thinks that for those small enterprises that want to certify FDA, the cost is large, the threshold is high, and the sales channel may be more difficult "After the FDA, there may not be a market Just like watching a concert, it is unrealistic to take a stand ticket and ask for the effect of rock zone In addition, even if the FDA has a market, it may not play well The market is a buyer's market, and those drugs without added value may not be profitable and cost-effective " "According to the sales situation of the products, it's not a question that anyone can't think about." China cube believes that whether or not to pass the FDA certification mainly depends on the positioning of the enterprise For those who are ready to enter the market of the other party, they need to pass the certification If it is purely for the purpose of enhancing their influence, it will be fine Otherwise, people will lose money Other netizens also said that there is no need or necessity to see if the boss wants to make money in the United States Industry insiders with relevant experience said that for APIs, exporting FDA does not mean how strong or good you are, because the potential environmental risks caused by API pollution are unimaginable; for traditional Chinese medicine, although not yet, even if there is one, it does not mean that the world will recognize you, and domestic resources are scarce and supply is unstable However, from the commercial point of view, market publicity, export is good, and it is also helpful for domestic sales What is FDA certification? Action geometry? According to public information, FDA is one of the executive agencies set up in the Department of health and human services (DHHS) and the Department of public health (PHS) in the United States As a scientific regulatory agency, FDA is responsible for ensuring the safety of food, cosmetics, drugs, biological agents, medical equipment and radiation products produced or imported in the United States Its purpose is to protect the safety and interests of consumers Internationally, FDA is recognized as one of the world's largest food and drug regulatory agencies This has also attracted many other countries to seek and receive FDA assistance to promote and monitor the safety of their products In recent years, with the influence of economic globalization and the implementation of China's product internationalization strategy, more and more Chinese pharmaceutical companies are trying to penetrate the sales tentacles into the European and American markets, aiming at the FDA certification of the United States, in order to open the door of the American market and even the global market Industry experts said that at present, domestic drug safety issues are highly valued FDA certification with scientific, rigorous and fair nature will effectively enhance the reputation and image of enterprises, improve the competitiveness of products, and help China's pharmaceutical industry to keep up with international standards As for the "certification fees" that make some drugs look forward to, in fact, the FDA charges for ordinary new drugs, over-the-counter drugs, medium-risk and low-risk medical devices that are affordable to domestic enterprises, so there is little to worry about.