Proceedings: DIA China 2019
DIA China 2019
Regulatory Reform Benefits Both Patients and Professionals

Yi Feng
Vice President of R&D and Chief Strategy Officer

Sichuan Kelun Pharmaceutical Co. Ltd.


harmaceutical R&D in China has truly become integrated into the ICH environment. As a result, any enterprise conducting R&D in China, or trying to get regulatory approval for a product in the China market, must adjust several regulatory aspects of their product registration strategy. Over the past few years, for example, the State Council has introduced a series of policies on accelerating reform of the drug inspection mechanism.

Key Takeaways

  • Biotechnology and pharmaceutical R&D in China is now being conducted under a global strategy based on globalization of investment and global cooperation in the IND/CTA process. Biotechnology and pharmaceutical companies in China now formulate their clinical development strategies with this global perspective.
  • These changes in clinical development strategy also require Regulatory Affairs (RA) professionals to make decisions based on global regulatory policies and review paths, but to implement those decisions within specific product or project circumstances.
  • These strategies, combined with ongoing regulatory policy reform, create new enterprise opportunities and space for development, resulting in more innovative treatments that have the opportunity to simultaneously benefit more patients, both in China and around the world.
  • These policy changes and supports for innovation, with a greater focus on unmet medical needs, have led to improved regulatory practices for multinational corporations in China.

Changes in NPMA regulatory policy have transformed regulatory affairs for multinational companies in the China market. Chinese Authorities’ acceptance of overseas clinical trial data, especially for recently approved and globally marketed oncology drugs, has required multinational enterprises to adjust their regulatory strategy in China. Instead of products being evaluated in China after they have been on foreign markets for years, China is now participating in global clinical studies generating the clinical data that support marketing applications, including in China. One emerging practice has been for enterprises to submit their product marketing application in the US first, to take advantage of available accelerated review policies, and then synchronize with their NMPA application in China. Improved regulatory practice in China, such as NMPA issuing new and improved technical guidelines in alignment with ICH requirements, is reflected in these activities.

Every regulatory effort for an innovative drug, whether it is for an IND/CTA or NDA or even just discussion with the appropriate regulatory authorities, requires articulation of the unmet medical need that drug is designed to address. This articulation should be logical and supported by clinical evidence; appropriately placed within the disease spectrum, means of existing treatment, and disease progress in the patient; and aligned with the requirements of all applicable regulations. Regulatory professionals who fulfill this obligation will deliver great benefits to patients in China and around the world.

Regulatory policy reform in China has also resulted in more and better career development opportunities for regulatory professionals, and presents an opportunity for them to systematically review and evaluate their accumulated knowledge of regulatory and registration strategies to determine their next professional steps. Regulatory reform in China has been beneficial for companies, their innovations, the patients these innovations were developed to serve, and the career development of regulatory professionals in China.