The impact of China's new ICH membership is front and center in the minds of Pharma executives. Case in point, FMD attended two high level conferences this past week and presented to our insights into this topic.
The 2017 International Conference on Pharmaceutical Innovation and Development was held in the beautiful coastal city of Yantai on 17-18 September. Dr. Dan Zhang, chairman of FMD, expert of “Thousand Talents Plan”, delivered a keynote speech entitled "opportunities and challenges brought by ICH".
Dr. Zhang pointed out that the CFDA has been carefully preparing for the ICH for some time. In the past 3 years, the agency released a multitude of policies in line with ICH standards, such as No. 52, 53, 54, 55 Guidance Documents (Draft), replacing certification of clinical trial institutions by record-keeping system, optimization of inspection procedures, accepting of foreign clinical trial data, and so on. Through the implementation of Marketing Authorization Holder (MAH) system and many other policies, we can see that the CFDA has long been paving the way for joining the ICH.
Of course China still has a long way to go to bring itself fully in line with ICH, including the number of technical guidelines, the experience of clinical researchers, the number of clinical research institutions. Challenges represent opportunities. For pharmaceutical companies, what will they do after ICH implementation? What kind of products will they develop to take advantage of the new environment? And how to find experienced clinical research institutions and operation team? For the investors, joining the ICH presents a real challenge of taking a fresh look at the overall strategy. Pharmaceutical companies and investors are both facing the corresponding challenges. All of these challenges require investors and pharmaceutical executives to re-think their businesses.
For China, joining ICH will do more good than harm to the domestic pharmaceutical industry. New drugs or orphan drugs can now more easily enter the international market, accessing much larger markets to recoup investments. As a result of a unified R & D market, global investment, especially in China, will be more valuable. More widely clinical data sharing make it possible to reduce repeated clinical trials. Investment is, in some ways, more efficient at a reasonable valuation. China's accession to the ICH will improve the overall research capabilities of new drugs. Who will be the winner? First of all, the biggest winners are patients. Chinese patients can access new and better drugs earlier than before. Doctors can offer patients more choices. Moreover China can participate in early phase clinical trials, allowing doctors to experience innovative drugs earlier, making it easier for researchers to innovate. Third winners are CROs, not only the clinical CROs but also the SMO, CMO and others in the value chain. Fourth is innovative pharmaceutical enterprises.
Meanwhile in western China, hundreds of scientists and executives gathered at the 4th World Nobel Laureates Medical Summit on September 16th, 2017 in Guiyang, an area known for its traditional medicine prowess. Five Nobel prize winners, more than ten Chinese and American academicians, over 100 distinguished experts, together with prominent leaders and senior investment institutions from biopharmaceutical industry in and outside of China participated in the summit, circling round the theme “Science-Fact and Fiction” to discuss the major program of medical science and technology.
FMD's Vice President Dr. Haishan Xiong gave a featured speech on ICH impact. Dr. Xiong focused on the strategic and the practical aspects of the trends in the market. He concluded that the drug industry is becoming a single global market. Those enterprises who invest in innovation and are prepared to take on the execution risks will thrive in this market.
Later Dr. Xiong participated in a panel discussion on cross boarder investment, which FMD has done a couple of times in its 10-year history. One of the panelists is Nobel Laureate Dr. Steven Chu, former Secretary of the Department of Energy of the USA. The panel was vibrant and attracted many participants.