On December 30th, the Chinese Food and Drug Administration announced that all the pharmaceutical enterprises who do not pass the newly revised “drug operation quality management practices” (referred to as Drug GSP) ¼Å’are banned from pharmaceutical operations as of January 1st, 2016.

Good Supply Practice (GSP) Standards are the basics to regulate and manage pharmaceutical products. The first edition was published in 2000. After several years of drafting and three rounds of public consultation, the Ministry of Health has at last published the revised Good Supply Practice for Pharmaceutical Products (Revised GSP Standards) (药品经营质量管理规范) on January 22, 2013. The newly revised version has higher requirements on quality control and inventory management and stricter record-keeping and tracking requirements. These requirements effectively enhanced the quality of medicines in circulation risk control ability and significantly increased business management.

According to the CFDA, all pharmaceutical enterprises must meet the standards of the revised GSP by December 31, 2015. From January 1, 2016 , all pharmaceutical enterprises that do not meet the requirements would be forced to stop drug business activities.

The government officials stressed that the new pharmaceutical retail enterprises need strict review and approval process. Moreover, the new pharmaceutical wholesale enterprises should meet modern logistics standards. Legal representative or responsible person in companies must have a licensed pharmacist qualifications. New pharmaceutical retail chain stores should be equipped with a licensed pharmacist .

Sources:

http://bit.ly/1W8nZJc, http://bit.ly/1l6X0jy

RegDesk is an A.I.-powered regulatory intelligence software that offers 24/7 access to the latest regulatory information for over 50 markets worldwide. Our platform eliminates the need for medical device companies to spend months gathering intelligence and preparing their registration applications. Through RegDesk’s centralized platform, clients can get access to product-specific registration requirements, expert answers to their most critical regulatory questions, and real-time alerts about global regulatory changes. To experience the power of RegDesk, contact us at desk@regdesk.co or visit www.regdesk.co.