“Thirteenth Five-Year Plan for the Development of Pharmaceutical Industry”

- Jan 14,2018 -

With the aggravation of population aging, the society pays unprecedented attention to the medical industry. According to the ideas previously determined, the formulation of the 13th Five-Year Plan for the Development of Pharmaceutical Industry (hereinafter referred to as the “Plan”) has entered the stage of receipt. According to the relevant workflow, this plan will be formally launched in the second half of the year. The plan points out that during the 13th Five-Year Plan period, China’s biomedical industry will focus on developing innovative drug categories such as major disease chemicals, biotechnological drugs, new vaccines, new cell therapeutic agents, and other major medical technologies such as bio-3D printing technology.

According to the statistics of the National Cancer Registration Center, in 2015, the number of confirmed cancer cases in China was about 4.3 million, and the annual growth rate was about 10%. In 2013, the number of diabetic patients in China reached 114 million, and the adult penetration rate was over 11%. However, for some malignant tumors and diabetes mellitus, there are few drugs with good therapeutic effect and high quality of life. Therefore, in the 13th Five-Year Plan, China will develop drugs for tumors, diabetes mellitus, nephropathy, cardiovascular and cerebrovascular diseases and antidepressants, and at the same time, increase the use of biomedical agents such as protein and polypeptide drugs, new cell preparations, which have great application prospects in clinic. R&D efforts.

China’s biopharmaceutical industry started late and developed rapidly, but at present many frontier biotechnology still lags behind Europe and the United States and other countries. Many pharmaceutical patent technologies are monopolized by Novartis, Pfizer, Roche and GSK and other international giants. Through the combination of generic biomimetic imitation and system integration, we can not only achieve the goal of overtaking in the technological curve, but also meet the current prevention and control of major diseases and breakthroughs in China. Drug demand for outbreaks and major health events. According to the planning objectives, in the next five years, China will focus on the development of 20 to 30 categories of medicines with huge clinical needs in order to achieve the scale of industrialization and realize that more than 90% of the important medicines whose international patents expire by 2020 can be manufactured independently. In addition, frontier biomedical technologies such as bio-3D printing, macromolecule drugs, stem cells, genes and so on will be greatly developed in the next five years.

The plan will also optimize and improve the new drug approval system. In the 13th Five-Year Plan, it is proposed to optimize and improve the policy of priority evaluation and rapid approval of new drugs, strengthen the expansion of the team of examiners and inspectors, refine and implement the State Council’s Opinions on Reforming the System of Examination and Approval of Pharmaceutical and Medical Devices, and ensure the approval of new drugs.

The Plan promotes pharmaceutical enterprises to achieve international standards and systems for drug quality. In 2004, China implemented GMP in an all-round way, and now more than 50 enterprises have passed the certification of the United States, the European Union, Japan and WHO. The plan points out that by 2020, at least 100 pharmaceutical preparations enterprises will be certified by developed countries such as the United States, Europe and Japan, and will export drugs. According to international drug standards, 10-20 chemical drugs and high-end preparations, 3-5 new Chinese medicines and 3-5 new biotechnological drugs will be developed and promoted to complete drug registration in developed countries of Europe and the United States and accelerate their entry into the international market.

The Plan also establishes standardized pre-clinical and clinical evaluation platforms. The state will standardize key platforms for preclinical and clinical evaluation of new drugs in accordance with international standards for quality management of clinical trials and non-clinical research of drugs.

The plan points out that by 2020, the state will promote 3 to 5 well-established universities and pharmaceutical enterprises to jointly establish large-scale pharmaceutical R&D bases with high technological level and R&D capabilities; at the same time, it will establish national transformation science centers and collaborative innovation centers, break through 10 to 20 key key technologies, and initially establish a national drug innovation system and innovation team.

Source: Chinese Academy of Sciences

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