Pharmaceutical Executive Europe - February 2008 - (Page 26) 26 Clinical Trials February 2008 Pharmaceutical Executive Europe Clinical trials for pharmaceuticals in China are typically conducted through one or more of the 251 Chinese hospitals licensed to conduct trials by the SFDA. These hospitals are scattered throughout China, each focusing on varied subjects. Any clinical trials related to new drug registration, including those for drugs to be imported from overseas, must be commissioned from one or more of these hospitals according to their specialities. For international multi-centre trials, drugs can be brought from overseas and used in any hospital the trial initiator deems qualified. The Chinese hospital to be commissioned as part of the international multi-centre clinical trial need not necessarily be one of the 251 granted a license by the SFDA. Importantly, this means that in the case of an international multi-centre programme, the drugs to be used for clinical trials do not have to be approved by the SFDA. However, the programme itself must be approved by the SFDA. In order to be used, drugs sourced from overseas for an international multi-centre programme must be registered in a foreign country for Phase II or Phase III clinical trials. If need be, the SFDA may request that the applicant conduct Phase I trials in China. At the end of the study, the applicant must submit the complete clinical study report to the SFDA. More complex and time-consuming is the process of sourcing drugs for clinical trials taking place entirely in China. In this case, the comparator drugs must be registered with the SFDA. The amended Measures on the Administration of Drug Registration do not specifically touch upon the use of imported investigational products, including comparator drugs used for clinical trials in China, and the entry of drugs used for such purpose would have to go through the same registration process as for imported drugs. For European-licensed pharmaceuticals to be used as a comparator drug in such a trial, they must be licensed in China as well. Absent this license, the SFDA would treat these drugs as imports and would require that the applicant follow the registration procedures for imported drugs, a time consuming and costly process. used in an international multi-centre programme elsewhere. Detailed records of these proceedings could facilitate the registration process in China and could help cut short certain procedures that would otherwise be required. Currently, however, the SFDA does not maintain an international standard list of comparators, making the use of an unregistered imported drug as a comparator a significant grey area in China’s current registration rules. While recent changes in China — most particularly its accession to the WTO — will provide significant business opportunities for foreign pharmaceutical companies by opening up a vast and virtually untapped market, challenges remain. Pharmaceutical manufacturers tapping this market through the development of new drugs in China and the conduct of clinical trials still face an environment of relative opacity compared to Western countries. This however, will continue to improve as the inexorable pace of change creates new opportunities and markets. References 1. China’s Growing Drug Market: Will You Be a Contender? Boston Consulting Group, 2002. 2. “Make Your Move: Taking Clinical Trials to the Best Location,” Executive Agenda, AT Kearney 2006. Guidelines for sourcing comparators One of the most important points in sourcing comparators, particularly in China, is maintaining a comprehensive, documentable paper trail or pedigree for the drugs involved. Though the SFDA and the Chinese government have taken a harder position against counterfeit drug production and potential contamination, it is imperative that any company carrying out R&D work in China secures its supply chain and maintains tracking documents from source to site to ensure consistency and safety, as well as the ultimate success of the trial. Proper documentation is also vital if the drugs that a pharmaceutical manufacturer intends to introduce into China have undergone a similar registration process in Europe or have been About the Author Angus G. Cameron is a director and senior vice president of Pharmarama, the US affiliate of BR Pharma Ltd. Prior to this, he was senior partner of Aeomica Ltd, a life sciences business consultancy, which he co-founded in 2002. Before Aeomica, he served as senior vice president (Europe) of Intergen Company, a New York based high-tech producer of pharmaceutical and academic research components. Mr Cameron also held senior management positions at Healthcare Technologies Ltd, Celltech Limited and Becton Dickinson Immunodiagnostics. He is a former board member of the UK BioIndustry Association.
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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