Laws of the People's Republic of China

The registration department of the state food and drug administration

Circulars on revising the procedure of submission and examination of imported drug

Letters No. 44 (2004) of the registration department of the state supervision and administration bureau of food and drug

March 23, 2003

Every port supervision and administration bureau of drug:

The departments have promulgated the circular on beginning to employ the procedure of submission and examination(Letters No (2003) 141 of the registration department of the state supervision and administration bureau of food and drug),which played a good role in favor of raising the efficiency of import registration and handling the registration procedure of imported drug. According to the feedback and suggestion of unit of submission and examination since implementing, the department determines to amend this procedure, increase security measures, and revise the unit description of the item on the quantity of submission and examination. the specific amended content can be seen in appendices. Every port supervision and administration bureau of drug notifies the unit of submission and examination of downloading the renewed software in the download area of www.sfda.gov.cn or www. nicpbp.org.cn in time, and employ this software to submit the list of submission and examination of imported drug.

Meanwhile, the department revised the administration system of edition R1.0 for submission and examination of imported drug correspondingly, would make CDs with the content of the upgraded directions, the upgraded procedure and the renewed procedure of submission and examination of imported drug as well would issue it to every bureau; the aforesaid bureau shall upgrade the t administration system for submission and examination of imported drug according to the upgraded directions. It's sure to contact the department in time if finding any problem in using it.

It is hereby announced

Annex: the revised content about the procedure of submission and examination of imported drug Annex:The revised content about the procedure of submission and examination of imported drug

1

Revised the item on the quantity of submission and examination. The binding item on the weight measurement kilogram is removed.

2

Revised the functions of saving the copy, printing the copy and printing the submitted materials. The specific revised content as follows:

Saveing the backup: the function of the key is to save the editing documents. The check-up numeral will keep unchanged without taping the button of printing the submitted materials before saving. The check-up numeral will be changed if taping the button of printing the submitted material before saving.

Printing the copy: the key serves the units who need to save the written documents, the function of the key is printing the written documents, but the printed written documents shall add the mark of "-T". the check-up numeral of written documents shall be consistent with that of the electrical documents.

Printing the submitted materials: the function of the key is to print the list of submitted materials and produce the new check-up numeral, the printed list of submission and examination shall add the mark of "-B". the saved check-up numeral of electrical documents shall be consistent with that of written documents.