Europe and the United States upgrade Import Supervision and foreign trade haze

Source: www.medcine.com on March 28, 2014, the US FDA issued the latest drug import warning, adding import warnings for some pharmaceutical enterprises in Canada, mainland China, Hong Kong, India and other countries and regions, including sun pharmaceutical, a famous generic pharmaceutical enterprise in India On the one hand, while European and American patent pharmaceutical enterprises are striving to seize the emerging market, China, India and other large generic pharmaceutical countries are striving to improve standards and open up global standard markets, and European and American countries are facing drug safety challenges from emerging markets; on the other hand, emerging market countries are also adjusting regulatory policies for patent expired drugs and even patent drugs, and some pharmaceutical enterprises' challenges to these patents accelerate their cooperation with The conflict of interest of patent pharmaceutical companies in emerging markets In consideration of many factors, European and American drug regulatory authorities have strengthened the monitoring of GMP system testing of overseas production bases of imported products, and the challenges of API, generic drugs and other manufacturers, including China, have intensified Facing the complex foreign trade environment, analysts suggest that we should pay attention to the protection of intellectual property rights at home, strictly implement the standards of certification countries, form a flexible business model overseas, and strengthen communication with overseas regulatory countries In the past two years, the U.S FDA and the European Union have significantly increased the GMP system inspection of pharmaceutical enterprises, especially with the rise of China, India and other large countries of generic drugs, the monitoring of relevant state pharmaceutical enterprises is more rigorous Take the "importalert66-40" warning issued by the FDA website as an example, the number of pharmaceutical companies that have been warned in 2010-2013 and have not yet revoked the warning is 11, 15, 19 and 44 respectively What's more, for the information of GMP system inspection of production bases outside the jurisdiction, the United States and EU countries have reached a cooperative relationship to some extent through Internet publicity or transmission This means that if the drug manufacturing bases in emerging market countries fail to pass the daily audit of FDA, or fail to meet the standard requirements of FDA in the next stage, and the relevant enterprises fail to quickly achieve correction or upgrading, the warning letter of FDA to the enterprises may be quoted by the EU Other news shows that in early April this year, the US China Economic and security assessment commission will focus on the Chinese pharmaceutical industry, the quality standards of Chinese pharmaceutical products imported from the United States and whether the treatment of American pharmaceutical companies in China will decline The United States has taken similar measures against production bases in India, Pakistan and other countries In this way, the development situation of American pharmaceutical companies in China is likely to have an impact on the relevant assessment of the Committee and other subsequent response measures The monitoring of API or generic products of overseas pharmaceutical companies entering the United States may be one of the measures Recently, the domestic and foreign factors promoted that benzathine penicillin of Huamin company of Huayao group has just been approved for sale in Japan For the current foreign trade environment, Liu Shulin, deputy general manager of the company, told reporters that China's pharmaceutical industry is developing rapidly, and local enterprises are actively exploring the international standard market For example, the number of products that the local pharmaceutical companies have obtained the Anda of the United States has exceeded 30, and the number of pharmaceutical companies that have obtained the EU certification is not small In order to appeal for the safety and security of the global integrated drug supply chain, Japan has also increased the frequency and intensity of inspection on overseas production bases FDA also has an office in China From the perspective of Sino foreign economic and trade competition, the vice president of an API export company in Zhejiang analyzed that in recent years, India and other countries have achieved a surge in Anda in FDA, and enterprises from China, Pakistan and other countries have accelerated their entry into the United States, which has had a certain impact on local enterprises in the United States, especially for products with low price and good quality In emerging markets, such as India's disapproval of the original research status of European and American patent expired drugs, even the compulsory licensing of patent drugs and other acts, have further stimulated policy makers in developed countries In addition, with the development of China's generic pharmaceutical enterprises and the adjustment of some regulatory policies, the growth of European and American pharmaceutical enterprises in China is also under pressure to some extent These factors have more or less led to stricter monitoring in Europe, the United States and other countries At present, China is transforming from a global API supplier to a pharmaceutical manufacturer In recent years, local pharmaceutical companies have also made good achievements in European and American Certification As an important sales market of Chinese api products and the main target market for drug product export, if the warning letter issued by FDA and others is not revoked, that is, the product cannot be sold in the United States, the loss of local enterprises will be huge In this regard, Liu Shulin said that the most important thing is still to implement the standard system of the certification country, especially the detailed requirements in daily operation     In the face of possible foreign trade challenges, experts from relevant associations recently wrote in this newspaper that we must treat patent problems of imported original research drugs with caution, prevent abuse of "compulsory licensing" and other acts, strictly follow European and American standards, especially details in daily production and operation, strengthen the ability to communicate with overseas regulatory authorities, and try to avoid them overseas More direct conflict of interest, low-key and bigger, and team work.