Chinese EU rebuffed: the quality of the pharmaceutical companies or the standard difference?
Such problems at present in the domestic chemical raw material medicine: one is the added value of the excess low bulk raw material medicine; the second is of bulk drug materials export competition, international pricing right to speak is not high; the third is from the API to formulation development, capability is weak.
"A batch of products has been rejected, the CEP Certificate (European Pharmacopoeia certificate of adaptability) was recovered, these cases in recent years, China's export of raw materials are very common. In fact, since July 2013, the European Union for imports of bulk drugs 62 orders since the implementation, the EU has to all raw materials imported drugs from the source began to tighten. Chinese medicines and health products import and Export Chamber of Commerce vice president Xu Ming in an interview with the first Financial Daily reporters, said.
Recently, the administrative department for medicine EMA EUROPEANMEDICINESAGENCY of Guangdong Pharmaceutical Co., Ltd. Zhuhai Federation's production of a series of sterile amoxicillin products ban, the cause of the incident is the Romanian health managers found that the company's production conditions failed to reach the EU standards, after the company of such products have been in France, Britain and other places for sale.
Is on January 22, French national medicines and health products safety agency also informed the North China Pharmaceutical Group's first Thai medicine in the EU's on-site examination was found 17 defects, including different departments of GMP document fraud (replacement of the contents, copy records, records the date and signature inconsistencies, etc.) and the QC laboratory data integrity problems (no access control, no audit trail, no delete data constraints, etc.) and residual solvent analysis results of fraud and other serious defects, North China Pharmaceutical were recovered (standards for quality control of pharmaceutical production) certificate of GMP related.
China's exports of raw materials in the EU has been rejected, it means that the export of raw materials is becoming increasingly difficult?
In fact in recent years, Zhejiang medicine (600216.SH) in the, Huahai 600521.SH as the representative of the Chinese pharmaceutical companies are trying to export preparation to the transformation of the export of raw material drugs. However, up to now, API export remains China's pharmaceutical exports of main products.
In the recently held the sixth of China and the world pharmaceutical entrepreneur peak, China Chemical Pharmaceutical Industry Association, President of the pan Guangcheng revealed that actually since the beginning of last March, China is already the world's second largest pharmaceutical market.
"It has now produced more than 1500 kinds of chemical raw materials, production reached 200 tons or so, in order to penicillin and so on behalf of the more than and 20 types of chemical raw materials exports accounted for the world's first." Pan Guangcheng said.
In June 2011, the EU promulgated 2011/62/EU new directive (i.e. "62 orders), from July 2013, all exports to the EU drugs are required to to produce a written declaration of export country supervision department, and ensure compliance with the" exporter GMP is equivalent to the European standard "strict requirements.
According to the EU's argument, 62 orders to improve the drug imports, to prevent counterfeit drugs into regular sales channels. However, the industry believes that this does not rule out a means of trade barriers.
Because the EU imports of raw materials from China and India each year, the amount of raw materials are very large, since the implementation of the annual CEP has been suspended, suspended the situation, up to 20 times a year." Xu Ming revealed.
But in the name of Xu Ming, strict supervision does not mean that exports blocked.
"In fact, 2014 China pharmaceutical raw material medicine total exports amounted to $25.9 billion. Overall it is a good, 1 to 4 months of this year, the growth also run win the national industry average." Xu Ming revealed.
"Transformation from the export of raw materials to the preparation of preparations is the focus of our current layout." Zhejiang medicine vice chairman Zhang Guojun previously told the "First Financial Daily" reporters told "raw material medicine production pollution, supervision of more and more strict, environmental protection investment, and the competition is more and more intense."
Previously, Zhejiang medicine had by the company stock fixed growth forms of financing the construction of Chang sea base, reporter learned that, at present, the base has been largely completed, it will bear the Zhejiang Pharmaceutical four part of the capacity of production: vitamins, biological medicine, new drugs and preparations, which preparation for most important layout, transformation of export agents determination is evident.
There is basically the market large raw material drug companies are in transition do preparation, way to digest its own production of APIs, and secondly to increase profits. " North China Management Consulting Group senior pharmaceutical partner Shi Lichen said.
Pan Guangcheng on API export transformation expressed their own views, domestic chemical raw material medicine currently has several problems: one is the added value of the excess low bulk raw material medicine; the second is of bulk drug materials export competition, international pricing right to speak is not high; the third is from the API to formulation development, capability is weak. "