Enhancing International Cooperation on Digital Technologies to insure People’s Well-Being
In this paper, we describe the development of digital technologies and their role in the development of the pharmaceutical industry, as well as new thinking about businesses, thought models, and the regulatory space. We look at how improvements can be made to our current situation by first examining certain advanced technologies and project cases in the fields of digital manufacturing, the Industrial Internet of Things (“Industrial IoT”), and blockchain tech globally, and then by analyzing the development of the global and Chinese pharmaceutical industry chains and the state of the China market.1.The current state of “Industrial Internet + Blockchain”, and recommendations
1) Digital transformation1 is currently a new stage in digital development. What this means is that not only can digitalization create new room for economic development and promote sustainable economic development, it can also promote the transformation and upgrading of traditional industries as well as the transformation and development of society as a whole. It is defined as the use of new-generation information technologies to form closed loops comprising data collection, data transmission, data storage, data processing and feedback and to eliminate information barriers between various levels and industries in order to improve the overall operating efficiency of the industry and to build a brand-new digital economy system. It includes an array of new technologies including Industrial IoT, cloud computing, Big Data, artificial intelligence, and blockchain technology.
Currently, China is vigorously promoting the implementation of whole-of-life-cycle traceability for vaccine and drug products, which is only possible if the industry were to undergo digital transformation. Therefore, digital transformation is also the key to the smart transformation of the pharmaceutical industry in the future.
2) In order to “meet the people's growing need for a better life”, in the last two years the National Medical Products Administration (NMPA) has correspondingly released a stream of policy documents and worked actively to promote the implementation of the related work.
Although we now have a good foundation, a conducive environment, and helpful policies, certain challenges still remain in terms of the digitalization of regulatory in the pharmaceutical industry:
· Growing complexity in terms of pharmaceutical formulations, processes and technologies creates new challenges for regulators
· The tremendous volume of data encountered over the drug life cycle calls for highly-efficient ways of data processing
· Pharmaceutical production can be further digitalized and made even “smarter”
· Lack of widely-adopted industry standards in data handling, thus data accuracy and completeness cannot be taken for granted
· Occurrence of severe epidemic has placed even more stringent requirements in terms of product development and supervision
3) Based on our understanding of the challenges mentioned above together with Siemens's experience in the pharmaceutical industry, below we have some recommendations and suggested solutions for how we can build a road with Chinese characteristics towards the digitalization and digital transformation of the pharmaceutical industry.
· The building of a “data ecosystem” along the entirety of the pharmaceutical industry's value chain
· Regulatory supervision and transformation centered on the pharmaceutical industry's Industrial Data Layer
· Knowledge graph for the pharmaceutical industry's entire industry chain
· A blockchain-powered tracking and supervision system for the pharmaceutical industry
· A smart regulatory supervision system and smart regulatory applications for the pharmaceutical industry
We hope that China will continue to open up and cooperate with international partners to build a transparent and efficient regulatory system based on the latest digital technologies.
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