Industry calls for reform of drug review system

A reform of China's drug review system is needed in order to hasten pharmaceutical innovation, industry experts said in a forum held in Beijing Friday.

In China, access to innovative drugs generally lags four to eight years behind other countries, due to the prolonged review process as well as the low capacity of the review body, said a report released Friday by the R&D-based Pharmaceutical Association Committee (RDPAC), an organization that represents 37 overseas pharmaceutical companies in China.

"We have a new drug being launched in Europe early next year, but we expect that the drug will not get approval in China until 2016," Ron Christie, senior vice president of RDPAC member company Novo Nordisk China, told the Global Times Friday.

"China's pharmaceutical industry has mainly focused on generic drugs over the past decades, so the current review system (for innovative drugs)… is still a factor that may bottleneck future innovation in the sector," Chen Qiyu, chairman of Shanghai Fosun Pharmaceutical Co, said at the forum.

For instance, the review process for starting clinical trials, an important step before a new drug can hit the market, can take as long as 10 to 18 months in China, compared with four months in India and only one month in the US, according to the RDPAC report.

The number of employees in the drug review body of the State Food and Drug Administration stayed the same at 120 between 2008 and 2010, while new drug applications grew by 14 percent each year during the same period, according to the report.

At present there are over 2,500 employees in the new drug review body in the US, and over 500 in the European Union.

Experts also urged that any reform of the drug review process should bring it in line with international norms.

A Chinese drug company executive said that in order to enter the overseas market, it must do the review process all over again, even if it has already completed the review in China, Zhuo Yongqing, executive president of RDPAC, told the forum.

China now has over 6,000 drug producers, but nearly 90 percent of them make generic drugs and have little investment in innovation. Experts at the forum noted that the less developed review system may be further discouraging innovation in China.

Christie said that companies such as Novo Nordisk allocate some 15 percent of their annual sales revenue to R&D each year, while for Chinese drug makers, "the average is only 1 to 2 percent."