The Food and Drug Administration issues regulations for the administration of drug export sales certificates

Editor:宏冠生物药业有限公司 │ Release Time:2018-11-20 

Food and Drug Administration of all provinces, autonomous regions and municipalities directly under the Central Government, Food and Drug Administration of Xinjiang Production and Construction Corps:


In order to further standardize the handling of the "Drug Export Sales Certificate" and provide convenience and services for China's drug exports, the State Drug Administration has formulated the "Regulations on the Administration of Drug Export Sales Certificates", which is hereby released, please follow the implementation. The relevant matters are notified as follows:


First, the provinces (autonomous regions, municipalities) are invited to follow the "Notice of the General Office of the State Council on Printing and Distributing the Implementation of the "One Network, One Door, One Time" Reform Plan for Further Deepening the "Internet + Government Affairs Service" (Guo Ban Fa [2018] No. 45) and this notice require that the internal application process be improved, the time limit for processing should be shortened, and online acceptance and certification should be actively promoted to facilitate export enterprises. If the conditions for informatization are mature, it may be replaced by electronic submission instead of paper copy.


Second, the National Bureau will establish a unified drug export sales certification information management system. Before the system is officially put into operation, the provincial (district, municipal) bureaus will upload the certificate data through the drug production and supervision information direct reporting system, including the original document (pdf file format). After the information management system is online, the certificate data information is transmitted according to the system requirements.


3. The State Council shall submit an examination opinion on the relevant documentary documents provided by the international organizations with relevant agreements with China in Article 4 of these Provisions. All provinces (autonomous regions, municipalities) can handle the matter according to the review opinions of the national bureau.


4. All localities should strengthen supervision over export pharmaceutical production enterprises, strictly follow inspection standards and standards in accordance with pharmaceutical production quality management standards, and focus on the implementation of supplier audits and implementation of data reliability requirements. While providing certification services to enterprises, they urge enterprises to continue to produce in compliance; if they fail to meet the requirements, they shall take timely measures.


V. These Provisions shall be implemented as of the date of promulgation. The Notice of the State Administration of Drug Administration on Printing and Issuing Certain Management Regulations for Issuing the Certificate of Sales of Drugs (Singuo Jianan [2001] No. 225) shall be abolished at the same time.