Publish time:10/31/2017 12:00:00 AM Source: CCM
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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
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.
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.
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.
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.
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.
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
The further development
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.
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.
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.
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.
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.
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