In order to standardize the order of drug development, intensify the on-site verification for drug registration and ensure the quality of verification work, the State Food and Drug Administration (SFDA) issued the Requirements for On-site Verification for Drug Registration on June 3,2008. As the regulatory document complementing Provisions for Drug Registration revised in 2007, the Requirements sets out specific requirements for the administrative subject, work processes, format of relevant documents and tables, and check points of the on-site verification; further explains relevant articles in the new Provisions for Drug Registration; details and defines the requirements of on-site verification for drug registration so as to institutionally guarantee the authenticity, scientificalness and standardization of the application materials and samples, and ensure the safety of drugs from the source.

The Requirements comprises 7 chapters, 59 articles and 5 attachments. It focuses on the confirmation of the authenticity, accuracy and integrity of the application materials in accordance with relevant requirements on on-site verification for drug registration in Provisions for Drug Registration, and ensures that the on-site verification for drug registration can be carried out legally, orderly, standardizedly and efficiently in terms of lawful content, clear procedure, uniform standards and clear division of labor.

Furthermore, the clinical trials of generic drugs and supplementary applications are also brought into the scope of on-site verification in the Requirements to indicate the concept of entire-process supervision.

The SFDA started to draft the Requirements from May 2007; solicited public opinions on SFDA's official website in September 2007 and February 2008; and revised relevant articles in accordance with the reasonable opinions and suggestions.