Curia's Approach To Regulatory Compliance In China

In recent years, China has undertaken substantial reforms of its regulatory framework governing Active Pharmaceutical Ingredients (APIs), bringing it into closer alignment with internationally recognized standards. These reforms are intended to strengthen oversight and ensure that pharmaceuticals entering the Chinese market consistently meet rigorous requirements for quality, safety, and efficacy.

While the regulatory environment has become more demanding, it also offers a transparent and well-defined structure for API manufacturers. This framework supports compliance with high technical and quality standards and encourages the adoption of best practices across development, manufacturing, and regulatory submission processes.

As a global leader in CDMO services, the following organization has proactively adapted to the evolving regulatory landscape in China. Leveraging decades of experience operating within complex global regulatory environments, it has developed strong expertise in navigating the specific requirements of Chinese regulations. A dedicated Local Regulatory Affairs Team based in China plays a critical role in supporting customers, ensuring successful regulatory outcomes, and facilitating smooth and timely market access.

Notable achievements include the approvals of Betamethasone Dipropionate Micronized API and Aztreonam, both of which were granted “A” status (approved) by the National Medical Products Administration (NMPA). These successes highlight the organization’s proven ability to navigate China’s regulatory processes and underscore its commitment to supporting customer success in this dynamic and strategically important market.