Chinese and foreign enterprises agree on China's latest pharmaceutical innovation plan

Source: FDC pharmasia news 2012-12-07 Beijing - according to a report released by the pharmaceutical research and Manufacturers Association of the United States (Pharma), China is likely to become a major driver of global innovation and be able to compete with the United States, but this requires integrating innovation into regulatory policies and investment decisions In the report "building an innovation driven pharmaceutical industry in China" released on November 30, PhRMA said that it is currently cooperating with the pharmaceutical research and development industry committee (rdpac) of China Association of foreign funded enterprises and Sino phirda to work together "for China, for the world, For the world "to stimulate pharmaceutical innovation In his opening speech, Joseph CHO, CEO of rdpac, told delegates from various industry groups that in Chinese, this cooperation can be described as "you have me, I have you" In a report related to the meeting, rdpac, a common concern, pointed out that delays in regulatory approval, uncertainty in pricing and bidding, and long waiting time for compensation have hindered the progress of new drug research and development in China Mr Chen Qiyu, President of Sino pharda and CEO of Shanghai Fosun Pharmaceutical Group Co Ltd., said that these problems have affected Chinese and foreign enterprises, so we have some doubts about whether the current system can cope with such rapid changes Last year, China's State Food and Drug Administration (SFDA) accepted more than 6000 new drug registration applications, but only 2750 of them were approved, Mr Chen said Recently, Fosun Pharma, listed on the stock exchange of Hong Kong, plans to invest 3.5 billion yuan (US $56223 million) in the construction of its biomedical R & D base in Zhangjiang High Tech Park, Shanghai, especially its monoclonal antibody, which is a new development direction determined by the company that still relies heavily on generic drugs ("China's Fosun Pharma targets $650 million IPO With Prudential Insurance As Cornerstone Investor" — PharmAsia News, Oct 23, 2012 4:40 PM GMT) 。 Mr Chen said at the meeting, however, given the current slow progress of regulatory approval in China, Fosun Pharmaceutical is also considering Taiwan He pointed out that since the signing of the cross strait medical and health cooperation agreement, Taiwan has made outstanding achievements in the development of new drugs for the mainland market ("case study: Cross Strait agreement could short ind timeframe for products entering China (Part 2 of 2)" - pharmasia news, Jun 22, 2012 12:54 pm GMT) Mr Chen said that the pricing problem is the biggest uncertainty in the Chinese market at present He pointed out that the current cost tax system still has a lot of room for improvement John Lechleiter, chairman of pharma and CEO of Eli Lilly & Co., recently proposed a "fair, transparent and consistent" pricing policy ("Lilly CEO: China must evolve fast if it waves to be a global player in innovation ecosystem" - pharmasia news, Nov 30, 2012 5:31 pm GMT) Furthermore, Mr Chen believes that the current bidding system of blindly pursuing price reduction is "very dangerous", which "violates the principle of innovation and ignores the differences in product quality" He pointed out that the new pricing system should reflect the R & D cost, social value and even clinical failure of products The national health insurance catalogue (ndrl) is another recognized obstacle for Chinese and foreign enterprises, because no matter what kind of drugs enter the market, the national development and Reform Commission only revises the ndrl once every five years The last revision was in 2009 ("lost in rehabilitation? Innovative drugs enroll length delays in China – IMS study" - pharmasia news, Aug 13, 2012 7:16 pm GMT) CHO, President of rdpac, pointed out that, in contrast, the UK, Germany and Singapore are rolling to update the new drug catalog; the update cycle in Thailand and Mexico will not exceed 6 months, and that in South Korea will not exceed 12 months ("MNCs and Chinese domestic companies becoming more in sync – pharmasia Summit" - pharmasia news, Sep 26, 2012 3:11 pm GMT) Mr Chen also suggested that the advantages and disadvantages of reimbursement for innovative drugs should be improved in the compensation scheme for medical expenses paid by disease group or in the fixed proportion compensation scheme Mr Chen said that in recent years, the Chinese government has increased medical and health expenditure and plans to further increase investment However, due to the increasing number of patients with chronic diseases and the large population base, it is still facing continuous budget pressure, which may be difficult to provide adequate compensation for new drugs Therefore, the government should actively introduce social and commercial insurance institutions and international insurance institutions eager to enter the Chinese market ("Roche looks to improve market access in China through patient assistance programs, insurance" - pharmasia news, Sep 12, 2012 5:20 pm GMT) Mr Chen added that the bidding system needed to add a special mechanism to allow new drugs to enter the hospital's formulary during the ndrl update interval Specific measures obviously, both the US and China's R & D enterprises think it is necessary to improve China's drug regulatory framework, and also put forward some specific suggestions, such as increasing the review fee, relaxing the relevant provisions of the first human clinical trial and so on SFDA plans to certify the first institution eligible for such research by the end of the year ("China prepares site for first in human studies but safety concerns main" - pharmasia news, Nov 9, 2012 8:26 pm GMT) Mr Chen also suggested that SFDA increase drug review fees to reduce false declaration According to the Research Report on the development of generic drugs in China recently released by SFDA Drug Evaluation Center (CDE), there are quite a lot of repeated applications for generic drugs For example, so far, the center has received 3950 generic drug applications this year, of which 58% have approved more than 20 varieties for marketing license ("China SFDA genetics report knows industries and regulator have a long road ahead" - pharmasia news, Nov 30, 2012 7:26 pm GMT) Both Lechleiter and Chen stressed the urgent need to increase the financial input of CDE and the human resources of review experts Mr Chen also suggested that the newly hired experts should have rich review experience, and experts from the United States and Europe could also be hired SFDA should have some flexibility in employment decision-making In fact, CDE recently introduced two new senior review experts at a meeting held in Shanghai: one was from Jiangsu Hengrui Medicine Co Ltd., a major Chinese tumor drug manufacturer, and the other was from Shanghai Pharmaceutical Corp., a contract research organization that has already been in the US Oncology, Diabetes and Cardiovascular Studies Lead Drug R&D Efforts" — PharmAsia News, Nov 26, 2012 7:23 PM GMT) 。