Pharmaceutical Executive Europe - February 2008 - (Page 25) Pharmaceutical Executive Europe February 2008 Clinical Trials 25 for pharmaceutical research. Its enormous population provides a large and readily-tapped patient pool for conducting clinical research. Moreover, with an estimated 200000 highly educated research scientists, combined with an extremely competitive market for laboratory jobs, costs are a fraction of those in the West. According to a 2006 White Paper by management consulting firm AT Kearney,2 conducting a clinical trial in China can cost half of what the same trial would cost in the US or the European Union. A number of large pharmaceutical companies are taking advantage of this dynamic by setting up large-scale research facilities in China. Novartis is reportedly constructing an R&D facility expected to grow to 500 scientists, while AstraZeneca has announced $100 million for R&D in the near future in China. This is in addition to a number of world-class research institutions established domestically, primarily in major population centres in Beijing, Shanghai and Guangzhou. To any company seeking to perform clinical research in China, these issues can cause serious concerns in sourcing trusted drugs for research trials. However, in response to these problems, the Chinese government has taken a number of important steps to address both safety and quality, as well as intellectual property issues. China’s response In July 2007, the Measures on the Administration of Drug Registration were amended and issued by the SFDA. These landmark amendments provide for a stricter drug approval procedure and a more efficient regulatory system. Among the important changes are • The requirement that the final approval process be made through a collective decision-making system rather than placing ultimate authority with one person, as was done previously. • The requirement that sufficient and reliable research data is provided, and that the drug administration authority conduct onsite inspection of non-clinical trials, clinical trials and manufacturing facilities to determine the authenticity, accuracy and completeness of application materials before marketing approval for a drug is given. Additionally, in December 2007, in response to international product recalls, the SFDA issued a new drug recall process that encourages companies to issue voluntary recalls if there are any safety concerns. The regulation also requires that manufacturers improve the quality of monitoring systems, promptly analyse information from hospitals, retailers and users, and evaluate potentially unsafe drugs. China also has taken significant steps to safeguard intellectual property, as displayed in a 2006 case where a Beijing Court issued an order in favour of Pfizer in a case involving 12 pharmaceutical manufacturers producing generic versions of its drug, Viagra. And while China still does not issue patents for pharmaceuticals, the SFDA rules on marketing exclusivity for particular drugs or drug compounds were revised so that exclusivity is granted to not more than three companies, creating an incentive to continue research and development work on new therapies. IP concerns Despite these positive macro trends for pharmaceutical R&D, a continuing issue facing Western companies conducting business in China is intellectual property (IP) rights and patent protection. As part of its entry into the World Trade Organisation (WTO) in December 2001, China is now obligated to enforce foreign international patents in accord with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) of 1995, the most comprehensive multilateral agreement on intellectual property rights. This framework mandates that drugs receive at least 20 years of patent protection. However, despite these protections, IP rights remain a major issue for overseas companies participating in the Chinese pharmaceutical market. Patent infringement is a relatively new concept in China, particularly with regard to drugs, which have traditionally been considered a special commodity to save lives that did not warrant patents. Enforcement of regulations is often difficult and sometimes politically influenced. And intellectual theft in China comes in numerous forms, including reverse engineering and copying and counterfeiting. This spectre of tainted and counterfeited products grew to be a significant issue and embarrassment to the Chinese government in 2007, with numerous quality control and safety concerns surrounding Chinese products. Major scandals surrounded export toys, pet foods and consumer products. And despite heightened controls and regulations enacted over the past several years by China’s State Food and Drug Administration (SFDA), a number of pharmaceuticals were also affected, such as the two cancer-fighting drugs, methotrexate and cytarabin hydrochloride, made by Shanghai Hualian Pharmaceutical Co, which were recalled. In the summer of 2007, the two drugs were found to be contaminated with another cancer-fighting chemical, vincristine sulphate, affecting hundreds of patients, causing partial paralysis in some cases. Deploying comparator drugs As in the West, an essential component to conducting clinical trials in China includes sourcing comparator pharmaceuticals. In many cases, the comparator products are already in the market. However, sourcing comparator drugs can at its very best be a complex process. In order to maintain the consistency of largescale trials, everything from the chemical composition of a comparator drug right down to the shape and size of the pill and packaging must be consistent and documented. Several issues make sourcing drugs in China particularly difficult, as there are distinctly different regulatory processes for international trials and those taking place in China exclusively.
Table of Contents Feed for the Digital Edition of Pharmaceutical Executive Europe - February 2008 Pharmaceutical Executive Europe - February 2008 Contents From the Editor News and Analysis Brussels Report Calendar R&D: Innovation - Learning to Share Drug Launch - The Preparation Game Q&A - Getting a Head Start Regulatory Compliance - Credible Compliance Clinical Trials - Establishing Trials in China The Mix - Relevant ROI Comment - Taming the Trader Last Word - Under the Microscope Pharmaceutical Executive Europe - February 2008 Pharmaceutical Executive Europe - February 2008 - Pharmaceutical Executive Europe - February 2008 (Page 1) Pharmaceutical Executive Europe - February 2008 - Pharmaceutical Executive Europe - February 2008 (Page 2) Pharmaceutical Executive Europe - February 2008 - Contents (Page 3) Pharmaceutical Executive Europe - February 2008 - From the Editor (Page 4) Pharmaceutical Executive Europe - February 2008 - From the Editor (Page 5) Pharmaceutical Executive Europe - February 2008 - News and Analysis (Page 6) Pharmaceutical Executive Europe - February 2008 - News and Analysis (Page 7) Pharmaceutical Executive Europe - February 2008 - Brussels Report (Page 8) Pharmaceutical Executive Europe - February 2008 - Brussels Report (Page 9) Pharmaceutical Executive Europe - February 2008 - Calendar (Page 10) Pharmaceutical Executive Europe - February 2008 - R&D: Innovation - Learning to Share (Page 11) Pharmaceutical Executive Europe - February 2008 - R&D: Innovation - Learning to Share (Page 12) Pharmaceutical Executive Europe - February 2008 - R&D: Innovation - Learning to Share (Page 13) Pharmaceutical Executive Europe - February 2008 - R&D: Innovation - Learning to Share (Page 14) Pharmaceutical Executive Europe - February 2008 - R&D: Innovation - Learning to Share (Page 15) Pharmaceutical Executive Europe - February 2008 - Drug Launch - The Preparation Game (Page 16) Pharmaceutical Executive Europe - February 2008 - Drug Launch - The Preparation Game (Page 17) Pharmaceutical Executive Europe - February 2008 - Drug Launch - The Preparation Game (Page 18) Pharmaceutical Executive Europe - February 2008 - Drug Launch - The Preparation Game (Page 19) Pharmaceutical Executive Europe - February 2008 - Q&A - Getting a Head Start (Page 20) Pharmaceutical Executive Europe - February 2008 - Q&A - Getting a Head Start (Page 21) Pharmaceutical Executive Europe - February 2008 - Regulatory Compliance - Credible Compliance (Page 22) Pharmaceutical Executive Europe - February 2008 - Regulatory Compliance - Credible Compliance (Page 23) Pharmaceutical Executive Europe - February 2008 - Clinical Trials - Establishing Trials in China (Page 24) Pharmaceutical Executive Europe - February 2008 - Clinical Trials - Establishing Trials in China (Page 25) Pharmaceutical Executive Europe - February 2008 - Clinical Trials - Establishing Trials in China (Page 26) Pharmaceutical Executive Europe - February 2008 - Clinical Trials - Establishing Trials in China (Page 27) Pharmaceutical Executive Europe - February 2008 - The Mix - Relevant ROI (Page 28) Pharmaceutical Executive Europe - February 2008 - The Mix - Relevant ROI (Page 29) Pharmaceutical Executive Europe - February 2008 - The Mix - Relevant ROI (Page 30) Pharmaceutical Executive Europe - February 2008 - The Mix - Relevant ROI (Page 31) Pharmaceutical Executive Europe - February 2008 - Comment - Taming the Trader (Page 32) Pharmaceutical Executive Europe - February 2008 - Last Word - Under the Microscope (Page 33)
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