RDPAC Issues “Pharmaceutical Quality Study Report”


[October 25, 2010, Beijing] Today, R&D-based Pharmaceutical Association Committee of CAEFI (RDPAC) issues the “Pharmaceutical Quality Study Report”. For the purpose to make Chinese pharmaceutical enterprises better cater to the new medical reform and improve drug quality in a continuous and initiative manner, RDPAC and Pharmaceutical Research and Manufacturers of America (PhRMA) jointly entrusted Ernst & Young to make a systematic evaluation and analysis on the quality system of Chinese pharmaceutical enterprises. 9 key factors of quality system with drug makers have been summarized through extensive survey on 13 leading pharmaceutical enterprises and numerous stakeholders. "Such 9 factors are essential for enterprises to establish, maintain and implement quality system since they represent the leading practice of Chinese pharmaceutical enterprises in operation; these data are also conducive to the in-depth understanding of regulatory agencies over quality management system practice of the whole sector and have laid a scientific foundation for further assisting the government to formulate operation scheme of relevant incentive measures," said Liu Zhenxian, president of RDPAC.  

A perfect drug quality system should cover the entire life cycle of products, which is an important foundation to ensure drug quality.

"The process determines the outcome. The purpose of the study is not only focused on product quality in narrow sense but reviewing various effective measures adopted by enterprises in quality assurance from the whole life cycle of a drug, i.e. finding out the difference of drug quality management system of enterprises. The study also shows that drug quality varies greatly even for pharmaceutical enterprises with qualified GMP certificate due to different quality management systems. Since it is impossible for us to check all the drugs and random inspection only gets a rough judgment to the quality of this batch of drugs, only inspection of composition for finished products cannot ensure continuous stability of drug quality on the whole. A perfect quality system is indispensable; secondly, delivery of qualified drugs is only a start. The drug quality assurance work should run through the entire life cycle from production to marketing of drugs, which cover four key links in drug-making value chain: production, clinical verification, pharmacovigilance, medical information and medical affairs. As a strict executor of drug quality standard, enterprises should make efforts for continuous improvement of drug quality. A series of measures after delivery of drugs by enterprises, such as Pharmacovigilance and medical information service, are also indispensible for the continuous improvement of drug quality. Finally, we also aware that pharmaceutical enterprises need a huge amount of fund and professional knowledge for establishing and maintaining drug quality system and some large-sized pharmaceutical enterprises have thousands of persons involving drug safety around the world," said Ph.D. Che Yan of Ernst & Young, one of the major researchers for this study.

Continuous improvement of quality is a necessary way for China moving from a big power to a strong power in drug making

Products "made in China" have been sold all over the world due to high-quality and low-cost advantages, among others, quite a few have become the world-level enterprises such as Huawei, Lenovo, CSSC etc., but Chinese pharmaceutical industry is large but not strong. Among over 5,000 pharmaceutical enterprises, none of them have entered top 50 pharmaceutical enterprises in the world, even if from the angle of generic drugs, Chinese enterprises have still a large gap from Teva, Sandoz and other generic drug tycoons. To enter the international market is an ideal of numerous Chinese pharmaceutical enterprises. Compared with pharmaceutical enterprises in other countries, the price of Chinese drugs is highly competitive, even less than RMB 0.01 per tablet for price of many drugs, but quality management system has not been in line with international standards yet, which make it difficult for many Chinese enterprises to enter the purchase catalog of authorities like WHO and various benevolent funds etc. paying close attention to cost performance. By 2012, drugs of 139 billion US dollars will lose its patent protection, which will be a good chance for Chinese pharmaceutical enterprises moving towards international market and carrying out "first imitation" and brand imitation. Only Chinese enterprises have set up a quality management system in line with international standard can Chinahave opportunities to share such a huge cake by going abroad, accomplishing the transformation from "a large power" to "a strong power".

Policy stimulation and guidance is a key for Chinese pharmaceutical industry to achieve successful upgrading

Ph. D. Chen Yi, health economics director of RDPAC said, "the development experience of mature international pharmaceutical market shows that, incentive policy from the government is of extreme importance to guide the sound development of pharmaceutical industry, for instance, Japanese government included innovation, effectiveness, merchantability/marketability, paediatric medication and other indexes and set no upper limit of total bonus with a view to encouraging enterprises to create new drugs. Since 2002, the mark-up percentage to innovation from Japanese government has been increased from 40% to 70%-120% in 2008. The average R&D input of top 10 pharmaceutical enterprises inJapanhas also been raised from 13.8% to 20.9% and the guiding function of policy is fairly obvious. For pharmaceutical enterprises, innovation and quality are like double helix of DNA in cell, but if the input in quality improvement and innovation cannot be paid back, the motive power for enterprises to increase their investment will pass out of existence."
As a kind of special commodity, drugs should not be completely measured by price. Quality is a key. The drug policies related to the current drug price management framework and invitation for bid have given full consideration to the most basic requirements available. It not only goes against the long-term development of Chinese pharmaceutical enterprises, but also tend to cause hidden troubles for quality and drug safety. Mr. Liu Zhenxian pointed out, incentives of policy for encouraging R&D are helpful to impelling enterprises to raise the R&D capacity and quality of drugs spontaneously and ensure the drug safety of the public; also helpful to improving the industrial concentration and helping more enterprises participate in international competition. Meanwhile, it is also a crucial point for China to evolving from a big power into a strong power in pharmacy and bringing benefit to the people ultimately.

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