Is it hard for China's pharmaceutical enterprises to go through the road of EU tightening the import of APIs?

Source: yicai.com/wang Yue 2015-06-30 "a batch of products are rejected and CEP Certificate (European Pharmacopoeia adaptability certificate) is withdrawn, which are common in the export of APIs in China in recent years In fact, since the implementation of EU decree 62 on API import in July 2013, the EU has tightened the API import of all countries from the source " Xu Ming, vice president of China Chamber of Commerce for import and export of medical and health products, said in an interview with the first financial daily Recently, EMA (European Medicine Agency) of the European Union Pharmaceutical Management Department has made an investigation on Zhuhai United Laboratories (Zhuhai federal Pharmaceutical Co., Ltd.) in Guangdong Province A series of aseptic amoxicillin products produced by the company have been banned because health managers in Romania found that the company's production conditions failed to meet EU standards, and the company's products have been sold in France, the UK and other places On January 22 this year, France's national drug and health product safety administration also reported that 17 defects were found in the on-site inspection of Xiantai Pharmaceutical Co., Ltd., a subsidiary of North China Pharmaceutical Group, in the EU, including the forgery of GMP documents of different departments (replacement of contents, copying of records, inconsistency of dates and signatures of multiple records, etc.) and the lack of data integrity of QC laboratory（ No authority control, no audit trail, no restriction on deletion of data, etc.), the analysis results of residual solvents were fake and other serious defects, Huabei pharmaceutical was withdrawn the relevant GMP (drug production quality management specification) certificate Does the fact that China's export of API products has been rejected in the EU means that API exports are becoming increasingly difficult? In fact, in recent years, Chinese pharmaceutical enterprises, represented by Zhejiang Pharmaceutical and Huahai pharmaceutical, are trying to transform from API export to pharmaceutical product export However, up to now, API export is still the main product of Chinese pharmaceutical export Pan Guangcheng, President of China Chemical Pharmaceutical Industry Association, revealed at the Sixth China and world pharmaceutical entrepreneurs summit recently that China has become the second largest pharmaceutical market in the world since March last year "At present, more than 1500 kinds of chemical APIs have been produced, with the output reaching about 2 million tons The export of more than 20 kinds of chemical pharmaceutical raw materials represented by penicillin occupies the first place in the world." Pan Guangcheng said In June 2011, the new directive 2011 / 62 / EU (the "order 62") issued by the European Union requires that, from July 2013, all drugs exported to the European Union should issue a written statement from the regulatory authorities of the exporting country, and ensure that they meet the strict requirements such as "GMP of the exporting country is equivalent to the EU standard" According to the EU, order 62 aims to raise the threshold of drug import and prevent fake drugs from entering the regular sales channels However, some insiders believe that this is a kind of trade barrier "Because the EU imports a large amount of APIs from China and India every year, since its implementation, CEP has been suspended and suspended every year, up to 20 per year at most." Xu Ming revealed But in Xu Ming's view, tight regulation does not mean that exports are blocked "In fact, in 2014, the total export volume of API of Chinese state-owned pharmaceutical enterprises was about US $25.9 billion, which was not bad on the whole The growth from January to April this year also surpassed the national industrial average." Xu Ming revealed "The transformation from the export of APIs to the export of preparations is the focus of our current layout." Zhang Guojun, vice chairman of Zhejiang Pharmaceutical, told the first financial daily that "API production and manufacturing are polluted, supervision is more and more strict, environmental protection investment is more and more, and competition is more and more fierce." Previously, Zhejiang Pharmaceutical Co., Ltd financed the construction of Changhai base in the form of fixed increase of shares of the company The reporter learned that the base has been largely completed It will undertake the production of four parts of Zhejiang Pharmaceutical production capacity: vitamins, biological drugs, innovative drugs and preparations, of which the production of preparations is the most important part of the layout The determination of transformation of preparations export can be seen "At present, most of the large API companies in the market are transforming to make preparations, one is to digest their own APIs, the other is to increase profits." Shi lichen, senior partner of Peking University Zongheng management consulting group, said Pan Guangcheng expressed his views on the transformation of API export, "at present, there are several problems in domestic chemical APIs: one is the surplus of bulk APIs with low added value; the second is the fierce competition in bulk API export, and the discourse power of international pricing is not high The third problem is the weak ability of development and transformation from APIs to preparations.