Interview with Yao Zhi: the era of ectd is coming. Lu Kai talks about the artificial intelligence dream of electronic approval

Lu Kai, who has been working in Bayer for 20 years, decided to go back to China and do something about it The era of ectd is coming There are many problems in the reform of electronic approval in China, and many pharmaceutical enterprises are waiting for the final policy implementation of the State Food and drug administration Lu Kai, who graduated from lunsler Institute of technology with a master's degree in Business Administration in the United States, has been working and studying in the United States for many years He once led Bayer's global registration and approval and document management system, and was responsible for the construction and operation of the global ETMF management system The professionals in the field of drug approval in China are in urgent need of guidance Lu Kai, who is in charge of the integrated product development of clinical registration in Shenzhen Zhiyao, makes use of rich industry experience and AI technology to build an integrated intelligent platform for automatic writing, automatic translation, automatic publishing and approval, which is his artificial intelligence dream Lu Kai, vice president of the integrated clinical registration product line of Shenzhen Zhiyao: what do you think are the pain points of registration and application of pharmaceutical enterprises? At present, our country implements paper-based approval, in which a lot of resources are wasted At the same time, many documents previously submitted to the Drug Administration for approval still need to be submitted again, which is also a burden for the drug administration staff Therefore, our country is ready to implement electronic approval, which to a large extent will slow down the waste of resources in the process of preparation and submission of documents and review of documents by enterprises and drug regulatory staff We believe that electronic approval will not only bring resource savings to the industry, but also greatly improve the overall review time In the field of electronic approval, it has been implemented for more than ten years in the world It is not difficult to implement electronic approval technology in China Now we are mainly restricted by talent bottleneck At present, there are only about 4500 people in China who know how to apply for electronic approval If we start to apply for electronic approval, there will be a lot of questions about enterprises We don't know how to do it well We think the above is some pain points in the industry Reporter: what do you think is the core value of ectd? With regard to the core value of ectd, our ultimate goal is to hope that we have an innovative drug or treatment scheme that can reach the patients in need quickly We make things that are usually time-consuming and laborious easier and faster through electronization The ultimate goal of all colleagues engaged in this work is to help the country, drive the whole industry electronic, and quickly deliver new treatment drugs and programs to patients Reporter: how do you evaluate the development ecology of ectd at home and abroad? I have been working in Bayer for 20 years and have been working abroad before Around 2003 or 2004, ectd began to be implemented in Europe At that time, we had participated in the construction of international standards of ectd In the United States, the implementation of the relevant regulations and policies of ectd is a little later, probably in 2006 From this point of view, we can see that the implementation of ectd in foreign countries has been very mature and has a history of more than ten years But at home, in terms of laws and regulations or policies, there are many areas that need to be clarified In the process of implementation, the drug administration of foreign countries (the United States and the European Union) has invested a lot of human and material resources to promote this matter The "drug regulatory bureau" does not want the policies implemented by itself to bring great burden to enterprises, so there will be a long buffer period During the buffer period, drug enterprises can choose to use electronic approval or traditional paper approval In order to encourage everyone to use electronic approval, it will give policy dividend, for example, using electronic approval can get a fast review channel From this point of view, many of our domestic enterprises are waiting for the final policy of SFDA Reporter: what are the problems with the implementation of ectd in China? There is a very special place in our country There are two languages in the approval process, Chinese and English In the United States or the European Union, the approval process is mainly in English In other countries, such as Japan and Canada, which implement electronic approval, there are also bilingual problems At present, the State Food and Drug Administration's draft on Bilingual consultation indicates that our Chinese documents have final legal significance, so the technical requirements of Chinese documents are higher than that of English documents, which are submitted for approval as a reference document Now in the process of submitting for approval, we find some untranslated informal submission documents, which we don't know how to deal with in the future For example, in the clinical trial report about the death or serious adverse reactions of patients, we need to write out the cases in the clinical trial of patients, many of which can be submitted directly in English without translation, but from its own content, it belongs to The formal submission of documents (translation required) and how to deal with the bilingual details are also the places we are waiting for further explanation from FDA Reporter: what else do you think needs to be done in the future in the field of ectd in China? The future intelligent development of ectd should be in two aspects, one is the enterprise side, the other is the supervisor side There are many places worth Chinese enterprises to contribute Ectd has been implemented in the world for more than ten years Most of the software providers related to electronic approval are foreign companies As many colleagues in the industry know, the system procurement of national drug administration has actually gone through two rounds of bidding At present, it is mainly a foreign company that is responsible for providing the drug administration review system We believe that if our Chinese company does better, the system used by regulatory agencies may also be provided by domestic companies in the future From our company's point of view, we not only focus on the present and create some products with artificial intelligence for the enterprise, but also focus on the future and hope that we can have the opportunity to make some systems with artificial intelligence for the use of regulators In fact, what we are doing is to integrate a large number of duplicate information through technology, so that the information can better adapt to the regulatory requirements For example, the document must be submitted in PDF format, and the version number of the PDF must be between 1.4 and 1.7 Now, the default version number of PDF should be 1.9 In this case, the enterprise needs to remember a lot of specific rules and invest a lot of human and material resources to check whether these documents are compliant In fact, this aspect can be completely solved by technology, which can save the enterprise's human resources and make the enterprise limited In the future, human resources should be put on the content of documents rather than on the format of documents, which may be the continuous efforts of enterprises in electronic approval Sulfur statement: this opinion only represents the author and does not represent the position of yaozhi.com You are welcome to exchange and supplement in the message area If you need to reprint, please be sure to indicate the author and source of the article.