The plans - detailed in two new documents covering drug approval reviews and distribution practices published last month - are part of a series of reforms enacted in China in recent months to improve the quality of medicines sold in the country and increase exports.
The SFDA said that “reform of the drug review and approval [process]” is necessary to encourage innovation, strengthen the clinical trial process and improve how it assesses generic pharmaceutical products.
The efforts will focus on four key areas, the first of which will be to create a favorable environment for innovative R&D with an emphasis on proving both that candidate compounds have better therapeutic effect and protecting the intellectual property rights of developers.
The agency also aims to change how it assesses generic drugs with an emphasis on the “rational allocation of review resources.” The document does not go into specifics, however it does mention that the plan is to adjust site inspection procedures to optimize review efficiency.
The management of clinical trials is another focus with – according to the document – adverse event monitoring, ethical review and information disclosure among the areas that will be looked at.
The final topic covered is the development of drugs for children. The SFDA wants to incentivise development of such medicines by setting up a system of priority reviews.
Distribution
The second document is a more formal set of guidelines covering good distribution practices or good supply practices (GSP).
The requirements, which are due to come into effect on June 1, are also split into four sections and according to the SFDA includes concepts of supply chain management; computer information management, storage temperature and humidity monitoring, pharmaceutical cold chain management and other management requirements.
“The revised GSP sets higher qualification requirements and higher standards for engaging in drug distribution. Compared with the current GSP, the newly revised GSP has higher requirements for quality management, which will effectively enhance the capability to control drug quality risk in the distribution process.”