China Unveils Major Reform Plan for Pharmaceutical Industry Regulation
The State Council Office of China has issued new guidelines outlining significant reforms in pharmaceutical industry regulation, setting ambitious targets for 2027 and 2035. The document (No. 53 [2024]) introduces several key initiatives:
First, the reforms aim to strengthen support for pharmaceutical R&D innovation by improving evaluation mechanisms and accelerating approval processes for urgently needed medications. The plan emphasizes traditional Chinese medicine development and enhanced intellectual property protection.
Second, the guidelines focus on improving regulatory efficiency by reducing clinical trial approval times from 60 to 30 working days in pilot regions. They also streamline supplementary application processes and optimize registration inspections.
Third, the document outlines measures to promote international cooperation and market opening, including alignment with global regulatory standards and support for cross-border pharmaceutical production.
The reforms target building a modern regulatory system by 2027 and establishing China as a competitive force in the global pharmaceutical market by 2035. This initiative represents a significant step toward improving China's pharmaceutical industry while ensuring drug safety and accessibility.
The guidelines demonstrate China's commitment to balancing high-quality development with stringent safety standards in the pharmaceutical sector, ultimately aiming to better serve public health needs.