In order to strengthen exchange and communication with the international pharmaceutical industry, to introduce reforms to NMPA’s drug review and approval system, and to share the working practices of NMPA as member of the ICH Management Committee, NMPA held 2023 ICH in China: Progress and Outlook Symposium in Beijing on September 12. The symposium was a hybrid meeting with Mr. Huang Guo, Deputy Commissioner of China NMPA addressing the participants. Officials of NMPA’s relevant departments and affiliated institutions as well as representatives of industry associations attended the symposium in Beijing. Mr. Jean-Christophe Pointeau, Executive Committee Chairman of RDPAC, President of Pfizer China, and Madam Kang, Managing Director of RDPAC, were invited to attend and offer remarks. A total of seven international industry associations were invited to this symposium. Janet Vessotskie, Deputy Vice President of Science and Regulatory Advocacy, PhRMA, and Jyothsna Krishnan, Director of Regulatory, Drug Development & Manufacturing, EFPIA, attended the symposium on site with representatives of other international industry associations, including JPMA, IFPMA, BIO, IGBA, and GSCF, attending online.
Mr. Huang Guo stated that China is deeply involved in aligning on global regulatory requirements for the development of biopharmaceutical products and seeks to continuously deepen international cooperation. Through joining International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and becoming an ICH management committee member, NMPA has been actively learning from and sharing with international peers, accelerating the coordination and harmonization of regulatory standards, promoting mutual recognition of international regulations, and jointly enhancing the development of the global biopharmaceutical industry. NMPA has always attached great importance to international exchanges and cooperation in drug regulation, as evidenced by its efforts to deepen its participation in the work of international organizations such as International Coalition of Medicines Regulatory Authorities (ICMRA), International Medical Device Regulators Forum (IMDRF), and ICH, and NMPA has submitted a formal application to become a part of the Pharmaceutical Inspection Cooperation Scheme (PIC/S), which is projected to further deepen bilateral and multilateral international cooperation. NMPA achieved recognition by the World Health Organization as a National Regulatory Authority (NRA) for vaccines in 2022, showing continuous efforts to improve China's drug regulatory system. NMPA has established multi-channel and multi-aspect communication channels with the industry to promote the high-quality development of the industry, and enable the public to better share the achievements of global biopharmaceutical innovation.
Zhou Siyuan, Director General of the Center for Drug Evaluation (CDE) of the NMPA and Head of the Office of ICH Affairs, shared the progress of ICH implementation in China, including implementation status of ICH guidelines in China, furtherharmonisation efforts of ICH guidelines, as well as the domestic research to inform emerging topics at ICH. NMPA joined the ICH in June 2017 and was elected as a member of the ICH Management Committee in 2018 and successfully retained the position in 2021. NMPA has implemented all ICH guidelines issued before it became a member of the ICH Management Committee, as well as those guidelines finalized with the contributions of NMPA thereby aligning China with international standards for technical requirements for drug registration. NMPA actively partakes in the harmonization of all active topics and continually drives for internationalization and modernization of drug regulation in China to increase biopharmaceutical research and development. Up date, NMPA has assigned a total of 72 experts to participate in 41 ICH Expert Working Groups (EWGs) dedicated to topics for harmonization and more than 2,000 EWG teleconferences. Since joining ICH 6 years ago, NMPA has implemented a series of reforms to promote harmonization of regulatory submission requirements with international standards, support simultaneous development and registration of drugs, strengthen drug risk management and pharmacovigilance, and improve the review efficiency of imported drugs. China's ICH work has entered into a new stage. In his speech, Mr. Zhou Siyuan spoke highly of the efforts made by regulatory authorities, academia and the industry to further advance the implementation of and adherence to ICH E17 (General Principles for Planning and Design of Multi-Regional Clinical Trials), and expressed his gratitude to RDPAC for its organization and coordination. Mr. Qin Xiaoling, Director-General of the Department of Science, Technology and International Cooperation, NMPA, discussed international cooperation between ICH and China in drug regulation. Mr. Yang Sheng, Director-General of the Department of Drug Registration, NMPA, delivered a speech on deepening the reform of the drug review and approval system and promoting the high-quality development of the biopharmaceutical industry.
At the symposium, Mr. Jean-Christophe Pointeau and Madam Kang spoke on behalf of RDPAC. Mr. Jean-Christophe Pointeau thanked and recognized the positive efforts and achievements of NMPA by enhancing international cooperation, advancing the implementation of ICH guidelines in China and participating in the international harmonization efforts of ICH topics. Embracing the vision of "Healthier China through Innovation", RDPAC has actively participated in international communications, as evidenced by holding the International Pharmaceutical Innovation Forum (IPIF) for many years. In addition, RDPAC has published multiple influential in-depth industry reports in partnership with a number of industry associations annually and actively strengthened the communication and cooperation with the government, promoting simultaneous Research & Development (R&D) and facilitating the development of the pharmaceutical innovation. Subsequently, Madam Kang affirmed the role of reform in driving the high-quality development of China's pharmaceutical industry, in her speech. China's innovation has become an important source of global innovation, ranking second in the world in terms of both the number of drugs approved for marketing and the number in the pipeline. To be specific, it has kept pace with the world in cell and gene therapy, etc.,. Industry believes the reform of the drug review and approval system implemented by NMPA since 2015, contributes to the continuous improvement in the efficiency and quality of clinical trials, enabling global simultaneous R&D and registration of innovative drugs. RDPAC has supported ICH training in cooperation with international industry associations (e.g., PhRMA) and the China Center for Food and Drug International Exchange (CCFDIE), recommended industry experts to IFPMA in cooperation with the China Pharmaceutical Innovation and Research Development Association (PhIRDA), and organized seminars on ICH E17 and Q series guidelines with the participants from regulators, academia and industry to promote in-depth exchanges between the three parties, and jointly assisted NMPA in advancing the international harmonization and implementation of ICH guidelines.
Dr. Janet Vessotskie, representative of the Pharmaceutical Research and Manufacturers of America (PhRMA), acknowledged the contributions of NMPA to ICH in her comments, shared opportunities for NMPA to enhance international harmonization and promote simultaneous R&D, and expressed her hope for more international cooperation and exchange opportunities in the future. Dr. Jyothsna Krishnan, representative of the European Federation of Pharmaceutical Industry Associations (EFPIA), shared the results of a survey conducted by EFPIA on the implementation of ICH E17 in the industry. The results of this survey showed a positive signal for the pooling strategy to be accepted by China’s regulatory authorities. EFPIA also expressed an interest in the implementation of quality-related ICH Q guidelines in China. Dr. Masafumi Yokota, representative of the Japan Pharmaceutical Manufacturers Association (JPMA), shared various ICH training opportunities of JPMA to enhance mutual understanding and coordination between regulatory authorities and the industry. Ms. Judith Macdonald, representative of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), shared IFPMA’s role and progress to identify experts to join the ICH Expert Working Groups (EWGs). Ms. Nancy Travis, representative of the Biotechnology Innovation Organization (BIO), fully acknowledged the efforts of NMPA in integrating ICH guidelines into its regulatory system and expanding the scope of implementation, including recommendations on specific guidelines. Mr. Nick Cappuccino, representative of the International Generic and Biosimilar Medicines Association (IGBA), expressed his appreciation for the importance of NMPA's participation in the ICH work for the registration of generic drugs in China. Ms. Judy Stenmark, representative of the Global Self-Care Federation (GSCF), also presented her federation's work in support of ICH. At the symposium, these representatives discussed topics such as implementation of ICH guidelines and in-depth engagement in the development of international standards. On behalf of their respective associations, they expressed the hope for meeting and communicating with NMPA at the ICH Meeting in Prague, to discuss cooperation.
This symposium also marked the first time that representatives of international industry associations came to China to participate in interactive discussions on site after the COVID-19 pandemic. On behalf of these international industry associations, PhRMA and EFPIA expressed a great interest in the conduct of decentralized clinical trials (DCTs) and the implementation of quality-related ICH Q series guidelines in China, receiving positive feedback from the regulatory authorities.
NMPA expressed its willingness to work together with all parties to adhere to the patient-centered and scientific, legal, international and modern development direction, continue to deepen drug regulatory reform and innovation, and accelerate the approval of drugs that are urgently needed. NPMA is committed to further expand external opening through high-quality international cooperation, jointly foster a good ecosystem for high-quality development of the biopharmaceutical industry, and protect and promote public health. As a partner in advancing a Healthy China, RDPAC would like to continue to work with all parties to enhance international coordination in the future.
RDPAC and PhRMA, in conjunction with international industry associations, annually hold the Joint Strategy Session (JSS), an important meeting between the industry associations to review their work and identify future priorities. JSS was held in the second quarter in previous years. This year, the JSS was specially adjusted to September with a view to enabling international industry associations to attend the "2023 ICH in China: Progress and Outlook Symposium" in person and co-organize the "Module III: the Special Forum of ICH Guidelines for Clinical Trails" at the International Biomedical Industry Innovation Conference Beijing Forum. The objective of this series of exchange activities was for the industry to engage with China's regulatory authorities to explore more international cooperation opportunities in the global pharmaceutical innovation network, and help China to further improve its regulatory system and ultimately establish an international, science-based, transparent and predictable regulatory system.