China about to speed up drug approval to boost industry development 10-31-2017

Despite China being the world’s second-largest pharmaceuticals market, the country still has some obstacles for pharmaceutical manufacturers to get the approval for launching new drugs in the Chinese market. The long and bureaucratic approval times have long been a thorn in the eye of producer and patients. Now, the Chinese government has announced to overhaul the system and speed up the processing time.


One of the biggest changes in the future will be, that the results of clinical trials that are gathered from foreign countries can be used for the pharmaceutical products registration in China as well, without the need for additional tests. Before, manufacturers needed to launch additional tests in China as well to gather the data for approval. This has caused a severe delay in the process of new drug approval. 

After all, many manufacturers in China have long struggled with the delayed approval of new drugs by China’s authorities, as the number of applications is increasing steadily for a comparatively small number of reviewers. The new plan aims to increase research and development in China’s pharmaceuticals industry and bring the country in line with the international existing standards. 

This goes along with China’s membership of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use in June 2017, which requires the national drug-approval agency to conform to international standards and guidelines. 


China’s pharmaceutical industry is in severe needs to be improved, looking at the number of new drugs released in the last 16 years. While the middle kingdom has only approved a bit more than 130 new products in this period, other developed countries like the USA have approved more than 430 new drugs.

According to market intelligence firm CCM, the launch of innovative drugs always lags behind in China. For the 29 typical new drugs that were launched in China in the last ten years, the launch of them were five to seven years late than in Europe and America. What’s more, new drugs have to be examined, which usually takes a long time in the middle kingdom. 

The R&D and production of generic drugs are encouraged to advance the consistency evaluation over the quality and efficacy of drugs. In China, the market value of generic drugs reaches USD75.20 billion. There are over 4000 pharmaceutical enterprises in China, and most of them are producing generic drugs. However, the quality of these drugs is not good enough, and an industrial integration is very imperative. The consistency evaluation will accelerate this. 

The further development in China 

The new plan of the Chinese government is only a part of the innovation that was introduced to boost the industry in the future. The State Council in China has furthermore recently released the five-year development plan for China’s pharmaceuticals industry, which gives a guidance for the further development of this large industry and what players, domestic and overseas, can expect. 

One of the main goals for the future development is to cover the production of almost every branded drug without patent protection in China, which is going to decrease imports significantly. To achieve this ambitious goal, the government is going to encourage innovation of new drugs and ease the approval for novel drugs to get market access. 

Another measurement is the building of well-equipped pharmaceuticals industrial parks throughout the country, where especially small and medium-sized companies can target highly selective drugs to develop and produce.  

Speaking of small and medium-sized companies, the highly fragmented situation of China’s pharma industry is one of the main challenges, which makes innovation so difficult in the country. Hence, the government in Peking is encouraging mergers and acquisitions to establish larger size companies with sufficient resources for effective research and development.  

Finally, the new five-year plan is targeting the oversupply of generic drugs in China. While novel drugs are going to be widely encouraged by the government, oversupplied generics will be controlled. The Chinese government now demands bioequivalence testing for generics to ensure the quality of those, and furthermore encourages qualified third-party verification service providers to also join the activities. 

About CCM

CCM is the leading market intelligence provider for China’s agriculture, chemicals, food & ingredients and life science markets. 


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