EU raised the threshold of the drug imports, some pharmaceutical companies in Hubei have been hit

Recently,EDQM issued instructions to improve the threshold of the medicines import,designed to prevent counterfeits from entering the formal distribution channels from July 1,2013.The directive required that all drugs exports to EU must have a written statement from the regulatory authorities of the exporting country, and to ensure to accorded with GMP regulations of the exporting country which are equivalent to the strict requirements of EU standards.

Industry insiders said that China was neither a member of ICH (International Conference on Harmonization),nor signed mutual recognition agreements about covering pharmaceutical raw materials with EU.Chinese regulators would face a lot of difficulties to issue a statement which accorded with EU standards.In addition, there are many Chinese medicine export enterprises who have the authentication of China and the EU GMP,mainly to the large enterprises existed many products exporting to the foreign countries with the name of the banner through the pharmaceutical intermediate goods,and chemicals.The implementation of the new EU import regulations about medicines must have great impacts on the western medicine products which are exported to Europe countries.

EU is the largest export market of China's western medicine products,according to the statistics of the China Health Insurance Association,in 2011 China's western medicine products exports' total amounts reached to $26.474 billion,of which western medicine raw materials amounted to $ 22 billion,accounting for 83%.

Currently, a part of Hubei pharmaceutical raw materials have a share in Europe and the United States market.A responsible person of an API raw material pharmaceutical enterprises indicated that the riboflavin of Hubei Guangji Pharmaceutical,the cyclosporine A or raw materials and intermediates of the Yangtze River Pharmaceutical's have been exported to bulk countries and regions such as the EU,South America,Southeast Asia,and the Middle East. Although some products have passed the national GMP certification,but they did not pass the EU certification.

This people analyzed that in recent years,the global generics drugs market's growth rate is faster than twice of the one of patent medicine market,which will definitely lead to pharmaceutical companies' zoom demand of the characteristics drugs,also bring the golden development period to the characteristics raw material drugs enterprises in China. While the EU's improving the threshold for drug importation,API export-oriented enterprises will suffered a disaster.

By Vivian