The drug supervision department has set up The 62 orders to deal with the imports of EU on raw material medicine

         In December 6th,the reporter in the China medical equipment Engineering Association 2013 annual meeting was informed that,at present the drug supervision and Administration Department of the state has been preliminarily determined,will be in for the units issued by the raw material exports to the EU documents,and the raw material exports to the EU's delineation of the scope of regulation,in response to the July 2nd the formal implementation of the EU related raw materials imported 62 orders,the specific implementation measures is expected to be published in 3 by the end of the month.
Export Regulatory upgrades
         In 2011 June,the EU adopted a related raw materials imported new directive 2011/62/EU (No. 62),regulatory requirements to export raw material medicine EU countries or regions must be a written certificate issued by the manufacturer every batch of products are in line with the EU GMP standard.The instruction is one of the foreign trade policy as a major "lethality" domestic raw material medicine industry.At present,China's exports to the EU's API approximately 3 types of products:the first category is "raw material medicine product drug production license" and the registered document of approval;second is the "drug production license",but without the approval number,raw material products for export;the third category is neither the "drug production license",also does not have the approval number of export products,the export products in chemical enterprises.State Bureau of drug safety production supervision department director Weng Xinyu said,the future national drug regulatory department has the first two categories of products in accordance with certain procedures written proof.Not the third issued document.
Foreign Trade Supply Chain Revolution
         The personage inside course of study says,a few years ago the national drug regulatory department has decided to put raw material medicine market,before also had the raw material drug investigation.The implementation of the EU directive 62,only accelerated the production and operation of national regulation API process,the raw material exports to the EU issued documents will be fundamentally purification chain international trade buying and selling.As everyone knows,exports of raw materials is the main force of China's pharmaceutical exports,which started earlier,achievements.Especially in the field of bulk raw materials,China has become the most important production and supply base of global.However,in international trade,China's raw material medicine has been to suppress the question existing at the same time,counterfeit medicine raw materials China international society also can be heard without end.In this case,the file security,confirm its uniqueness is particularly important.In addition,established a nationwide and customs linkage database is one of the key means to exports of chemical products.Drug administration departments issued implementation document measures to export the EU raw material medicine,will conduct a comprehensive carding on exports of raw materials procurement supply chain in China, which will eventually lead to a transparent,it is a challenge for regulators and enterprises.But in the long run,it is beneficial to the purification of Chinese material medicine market,enhance the international competitiveness of Chinese crude drugs.

By Joseph