Report Interpretation: Driving faster development of the biopharmaceutical industry with better regulations

In 2021, Cytiva and the Financial Times published the Global Biopharma Resilience Index, which provides an in-depth analysis of the performance of the biopharmaceutical industry in five key pillars: government policies and regulations, talent pool, R&D ecosystem, production agility and supply chain resilience, and provides clear recommendations
on how the industry can shape a more resilient future.

This year, based on the success of the index release, Cytiva further focused on one of the pillars – government policy and regulation
.

The report pointed out that the global government is achieving faster industry development with more perfect regulations, and as a well-known industrial media in China that is committed to promoting the development of biomedicine, after sorting out and analyzing the development of new drug review and approval regulations in China in recent years, it is found that at this level, China and the world maintain the same step of adjustment
.

The clarion call for policy "acceleration" has long been sounded

The biomedical industry has always been highly valued by governments at all levels, and is also supported by the national industrial policy
.

When it comes to the government's policy of encouraging pharmaceutical enterprises to innovate, the first thing is the priority review of innovative drugs, rare disease drugs, children's diseases and urgently needed clinical drugs taken in the "Opinions on Reforming the Review and Approval System for Pharmaceutical Medical Devices", and it is also possible to carry out related approvals for the original and auxiliary packages of drugs (that is, raw materials, excipients, packaging materials), which greatly shortens the approval time of enterprises and improves the efficiency and quality
of innovative drug approval 。 In addition to giving the "green light" to innovative drugs in the approval process, innovation in the patent term protection system has also been carried out in the protection of rights and interests, such as patent term compensation, and in the "Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Pharmaceutical Medical Devices" issued in 2017, it is pointed out that the patent protection time spent by innovative drugs in the application process can be further compensated
.

With the change of time, regulations and policies accelerate the approval of innovative drugs

In recent years, under the impetus of the new crown epidemic, the national accelerated policy on biological innovative drugs has been increasing
.

At the same time, these initiatives are also being used in other innovative drug fields
.

According to the "Annual Report on the Progress of Clinical Trials of New Drug Registration in China (2021)" released by CDE in June this year, the total number of drug clinical trial registrations in China exceeded 3,000 for the first time in 2021, of which new drug clinical trials accounted for more than 60%.

▲ 2021 China New Drug Registration Clinical Trial Progress Annual Report Image source: CDE official website

The policy force is not stopped, and the future can be expected

Looking back on the past, China's innovative drug development has made gratifying progress, which is a major achievement
in the reform of the drug review and approval system.

In order to further encourage the development of innovative drugs, in 2022, China has also promulgated a number of relevant policies to encourage innovation, such as the "14th Five-Year Plan" Pharmaceutical Industry Development Plan, "Drug Review Center to Accelerate the Review of Innovative Drug Listing Application Review Work Procedures (Trial)", etc
.

As the results of this year's Global Biopharmaceutical Resilience Index survey of 500 pharmaceutical executives around the world, 60% of respondents expect the speed of drug approval to accelerate in
the next two years.

▲ Biopharmaceutical company executives expect drug approvals to be accelerated Image source: FT Chinese.