On Nov. 9th and 10th, 2021, the R&D-based Pharmaceutical Association Committee (RDPAC) held virtual “Global R&D Leaders Webinars”. The webinar aims to share ecosystem and simultaneous development status in China, helping the global R&D leaders of MNCs further understanding the China situation and listening to the feedback and expectation from the leaders on “The 4th Sub report of Fostering China’s Pharma Innovation Ecosystem: Promote Simultaneous R&D, Registration and Review of Innovative Drugs” (hereinafter referred to as the “Simultaneous Development report”), in addition to exploring potential accesses to include China into their global development programs. 19 global R&D leaders from 13 RDPAC member companies had warm discussions on the current status, challenges that China faces on further joining in global simultaneous development so as to achieving the goal of simultaneous R&D, registration and review.
Webinars’ participants paid close attention to the three approaches available to achieve global simultaneous R&D, registration, and review of innovative drugs in the Simultaneous Development report. They agreed that more and more MNCs focused on the two approaches during developing strategies: firstly, China participates in global simultaneous R&D as soon as the early clinical trials starting up; secondly, China joins in mid- and late-stage of global multi-center trials. The participants pointed out that it helps speed up the global simultaneous R&D that Chinese drug regulatory authorities full utilize the accelerated review pathways and accept overseas clinical trial data. However, in the meantime, HGRAC approval and clinical research capabilities are still the main factors affecting China’s simultaneous development. In clinical research, assuring data completeness, quality and connectiveness will promote global simultaneous R&D, registration and review. With rich clinical resources, the number of trial sites in China grew from 400 to over 1,000 in the past 5 years. Pharmaceutical companies have been leveraging collaboration with leading institutes and the third-party vendors for clinical research. However, it is essential to improve the capabilities of these clinical trial sites in China, especially of those new ones.
Simultaneous Development report is one of 4 sub reports of report series on “Fostering China’s Pharma Innovation Ecosystem”, which are jointly launched by RDPAC and China Pharmaceutical innovation and Research Development Association (PhIRDA) ever since early 2021. On the basis of the achievements in pharmaceutical innovation driven by China’s drug regulatory reform over the past five years, the attention is focused on two themes saying regulatory approval and clinical research throughout the process of simultaneous development, registration and review. The purpose of this report is to promote innovative drug development in China to keep in alignment with other countries in the world. After the release of the Simultaneous Development report, it has received positive feedback from all sides of the government, industry, academia and research institute, and aroused great attention in RDPAC member companies. Comments shows that the continuous improvement of China Drug Innovation Ecosystem and integration of global is providing a more favorable condition for China to further join in global simultaneous development, meanwhile, it put forward higher requirements for the company headquarters for resources and supports to China.
The webinar firstly invited Ms. WANG Jin, Partner of McKinsey, and Mr. SHAO Yi, Associate Partner of McKinsey, to have detailed introduction on report background and main content, including the whole status of innovative drug research and development in China, the key challenge and suggestions for registration regulation and clinical study and so on. Mr. ZHANG Kezhou, chair of RDPAC R&D Committee, Novo Nordisk Corporate Vice President, Clinical Development, Medical & Regulatory Affairs, Quality Assurance, and Ms. WANG Li, co-chair of RDPAC R&D Committee, Eli Lilly China Senior Vice President, Head of Drug Development & Medical Affairs Center, gave patient and meticulous answers to the questions, aiming to help member companies to get strong support from headquarters for R&D investment in China to leverage China's strong value in the global R&D system by sharing information of the most updated and comprehensive knowledge of China innovation drug development ecosystem. Ms. Sara WANG, Senior Director of RDPAC Science & Regulatory Department, introduced that RDPAC has been actively making efforts to support drug review and approval system reform, in 2016, RDPAC together with 3 local industry associations released “Fostering China’s Pharma Innovation Ecosystem (1.0)”, laid out a framework for establishing a pharma innovation ecosystem, in which many suggestions of regulatory system in the report were adopted by NMPA already; In 2021, the “Fostering China’s Pharma Innovation Ecosystem (2.0)” was released, which has a review of the past 5 years, a vision and in-depth analysis of the future, target to continuously promote and improve China's pharma innovation ecosystem.
Representatives from 13 RDPAC member companies, including ALK, Baxter, Boehringer Ingelheim, Eli Lilly, Ferring, Kyowa Kirin, Mundipharma, Novartis, Novo Nordisk, Pfizer, Roche, Servier and Takeda, attended the webinar. Ms. Sara WANG mentioned that it was hoped that member companies' headquarters consider including China in their global R&D plans as early as possible when developing their global R&D strategies through discussions like today’s webinar.
In the future, RDPAC will continuously support the promotion of improvement of China ’s Pharma Innovation Ecosystem, continuously establish the platform for high-level dialogue on the topics causing high-attention by member companies and headquarters, to share the united understanding on China’s regulation and the influence, and the experience and successful cases of simultaneous development and registration, to address China dynamic needs in global R&D strategy and potential short-term and long-term solution guidance, help member companies to integrate China into global development plan.
