REGULATORY REGISTRATIONS IN CHINA

The strategic role of Regulatory Affairs and the opportunities in the Chinese Market

In the pharmaceutical sector, Regulatory Affairs are a pivotal element for bringing products to market, ensuring that every active ingredient complies with international regulations. In such a highly regulated environment, Sterling’s expertise is crucial to ensuring that our products reach global markets while adhering to the highest standards of quality and safety. China, now the second-largest pharmaceutical market in the world, is marked by both its dynamic nature and regulatory complexity. The country is accelerating regulatory reforms to align with international standards, emphasizing drug innovation and quality. However, registering a product in China requires not only in-depth regulatory knowledge but also a strategic approach that accounts for the country’s cultural and regional specificities. With its growing focus on quality, China presents significant opportunities for those who can navigate these complexities with expertise and vision.

In the pharmaceutical sector, Regulatory Affairs are a pivotal element for bringing products to market, ensuring that every active ingredient complies with international regulations. In such a highly regulated environment, Sterling’s expertise is crucial to ensuring that our products reach global markets while adhering to the highest standards of quality and safety. China, now the second-largest pharmaceutical market in the world, is marked by both its dynamic nature and regulatory complexity. The country is accelerating regulatory reforms to align with international standards, emphasizing drug innovation and quality. However, registering a product in China requires not only in-depth regulatory knowledge but also a strategic approach that accounts for the country’s cultural and regional specificities. With its growing focus on quality, China presents significant opportunities for those who can navigate these complexities with expertise and vision.

During 2024, Sterling achieved a dual strategic milestone with the regulatory approval of the DMF (Drug Master File) in China for two of its key products: Fluticasone Propionate and Etonogestrel. The DMF approval for Fluticasone in China addresses the rising demand for treatments for respiratory and allergic diseases, a need amplified by pollution and other environmental factors. Meanwhile, the regulatory approval for Etonogestrel marks a significant step toward ensuring access to modern and effective contraceptive methods in a country increasingly focused on reproductive health. This milestone further strengthens Sterling’s position in this strategic therapeutic segment.

During 2024, Sterling achieved a dual strategic milestone with the regulatory approval of the DMF (Drug Master File) in China for two of its key products: Fluticasone Propionate and Etonogestrel. The DMF approval for Fluticasone in China addresses the rising demand for treatments for respiratory and allergic diseases, a need amplified by pollution and other environmental factors. Meanwhile, the regulatory approval for Etonogestrel marks a significant step toward ensuring access to modern and effective contraceptive methods in a country increasingly focused on reproductive health. This milestone further strengthens Sterling’s position in this strategic therapeutic segment.