The export of domestic pharmaceutical enterprises to the EU will be guaranteed by the government

2013-05-13 source: Beijing business daily a few years ago, the new policy of traditional herbal medicine launched by the European Union kept almost all traditional Chinese medicine out of the door, while the EU API directive, which will be formally implemented in July this year, once worried Chinese enterprises However, yesterday's reporter learned that the State Food and Drug Administration (hereinafter referred to as "CFDA") has issued documents for the EU's new regulations on APIs, requiring the provincial drug regulatory authorities to cooperate to provide relevant qualification certificates for API manufacturers, which makes the enterprise's two-year-old heart finally be able to land According to the General Administration of food and drug administration, API with drug approval number produced by enterprises with drug production license of China or API without drug approval number produced by enterprises with drug production license of China can be issued with API certificate for export to EU However, in the second case, the enterprise also needs to accept the on-site inspection of the provincial food and drug administration In addition, according to the regulations, after the provincial drug administration issues the relevant supporting documents, if in the subsequent inspection, it is necessary to withdraw the GMP certificate or consider that the conditions for issuing the supporting documents are not met, the relevant information shall be reported to the general administration within 24 hours after the decision is made, and the General Administration shall uniformly report the information to the European Union It is understood that in June 2011, the EU issued the new directive 2011 / 62 / EU (i.e "order 62"), which requires that, from July 2013, all drugs exported to the EU should issue a written statement from the regulatory authorities of the exporting country, and ensure that they meet the strict requirements such as "GMP (drug production quality management specifications) of the exporting country is equivalent to EU standards" According to the EU, order 62 aims to raise the threshold of drug import and prevent fake drugs from entering the regular sales channels But many pharmaceutical companies believe that this is actually a means of trade barriers The data shows that China's API export has ranked first in the world, and the EU is one of the main markets for China's API export Therefore, the order 62 issued by the EU requires export enterprises to issue relevant supporting documents, which once caused panic among domestic API enterprises However, it is worth noting that even with the support of the General Administration of food and drug, China's export of pharmaceutical products still faces many difficulties "Influenced by the weak demand in the international market, the rising cost of production, the increasing friction in international trade, and the stricter domestic regulatory environment, the difficulty in the development of China's pharmaceutical foreign trade is increasing." Person in charge of medical insurance chamber of Commerce