With the theme of rooted in China, aiming for the world, the “2022the second ChemCon Chemical Drug Innovation & Development and Regulatory Forum” hosted by E Pharmaceutical School was held in Nanjing on September 15-16, 2022. During the two-day meeting, insightful presentations were delivered, covering the areas of small molecule drugs going abroad, innovation and development, process optimization, quality analysis methods development, registration and application of new and improved new drugs.

Jun Li, Director of Regulatory Affairs at Elixir Clinical Research, participated at the Chemical Drug Registration & Application and Regulatory Forum as a host and guest speaker on the morning of September 16. Global frontier biopharmaceutical technologies are evolving rapidly, and the policies and regulations for drug registration and application are constantly being updated. New changes in regulations of drug registration and their impact on pharmaceutical companies were the topics in this forum. Jun Li shared hot topics such as patent protection strategies for innovative drugs and development ideas for improved new drugs with representatives from different companies from multiple perspectives and levels.

To bring a new drug to market, we need to follow the rules of regulatory authorities and get their approval under the premise of science and data. With the release and implementation of the new version of Measures for the Administration of Drug Registration, new drug development and communication have been encouraged and strengthened. Focusing on the stage characteristics of clinical new drug development, Jun Li comprehensively summarized regulatory requirements for new drug marketing application under the new regulatory system, and discussed it from regulatory perspective based on the background of chemical drug marketing application, combined with rich practice experience of Elixir Clinical Research.

Elixir Clinical Research provides regulatory submission management services covering a drug’s entire life cycle. Elixir Clinical Research has a professional and compliant team that communicates closely with regulatory authorities to submit applications that meet regulatory requirements and product characteristics to ensure smooth and efficient drug marketing.