The Regulation also lays out the responsibilities of drug administrative departments. The regulators will take classified management of pharmaceutical excipients, for that new excipients and excipients with high safety risks will require registration approval with manufacturers obtaining the drug production licensing, and for the other excipients, the information of product and the manufacturer should be submitted to regulators via record-keeping approach. As for the imported pharmaceutical excipients, approval or recording-keeping under SFDA should also be applied to. The excipients under the approval management shall be published in batch-wise renewal by SFDA.

The regulators of all levels will strengthen daily supervision or spot check for pharmaceutical manufacturers and excipient manufacturers, and carry out further inspection to excipient manufacturers regarding the illegal problems discovered from the corresponding purchasers (pharmaceutical manufactures). When illegal actions found, the relevant enterprises and the person in charge shall be punished in accordance with Pharmaceutical Administration Law and other relevant regulations. And in order to facilitate a comprehensive supervision of excipients, besides to establish a database covering the production and use of pharmaceutical excipients dynamically, the regulators will make credit files for excipient manufacturers and expose their inspection and spot check results to the public, which offers reference for drug manufacturers when choosing a qualified excipient supplier. The trade associations, third-party organizations and the public are also welcome to join in, with their supports the regulators will be much powerful to supervise the pharmaceutical production and supply chain.

In China, the development of pharmaceutical excipients industry lags behind, without strict supervision and price-oriented. But now as the state raises access threshold, many unqualified enterprises without production licensing and failing to meet GMP will lose their market share. Though strengthening the supervision of pharmaceutical excipients will raise the enterprise cost, it benefits a lot to regulate the market and assure the product quality.