MOFCOM Pushes Five Pharmaceutical Industry Standards

On November 27th, the Ministry of Commerce held a working conference on the promotion of pharmaceutical circulation industry standards in Beijing. It is reported that in the announcement No. 58 of 2012 previously issued by the Ministry of Commerce, the five pharmaceutical circulation industry standards will be implemented on December 1, 2012. The major breakthrough of this standard is the issuance of grading standards for chain retail pharmacies and drug distribution companies, and for the first time, the professional manager standards are introduced at a national level for a specific industry.

The five pharmaceutical circulation industry standards are: Evaluation Index for Logistics Service Capability of Drug Wholesale Enterprises, Regulations for Retail Pharmacy Operation Services, Guidelines for Good Manufacturing Practices for Drug Distribution Enterprises, Standards for Professional Managers in Drug Circulation Industry, and Pharmaceutical Circulation Enterprises The "Job Setting Standards", as China's first batch of pharmaceutical distribution industry standards, is also the first batch of standards for the pharmaceutical distribution industry since the founding of the People's Republic of China, filling the gap in China's pharmaceutical distribution industry standards.

According to Wen Zaixing, inspector of the Ministry of Commerce’s Market Order Department, in response to a series of problems in the field of pharmaceutical circulation in China, in August 2009, the State Council clarified that the Ministry of Commerce was in charge of the drug circulation industry, formulated industry-related standards, and resolved the problems in the development.

The five standards announced this time were led by the Ministry of Commerce and led by the China Pharmaceutical and Business Association. All relevant industry associations and pharmaceutical distribution companies actively participated in the drafting of the argument and announced the opinions of related departments. Among the five criteria, the most noticeable change is in the classification system of chain pharmacies and drug distribution companies.

“According to the statistics of the 2012 survey, China has a total of 460,000 retail pharmacies. The basic status quo is 'spread', 'small', and 'poor'. In order to change the status quo in the industry and regulate business practices, the “Pharmaceutical Drugstore” promulgated this time. The “Specifications of Business Services” clearly classifies all pharmacies in China into three levels: A, AA, and AAA, “said Ye Zhen, deputy general manager of Beijing Golden Elephant Pharmacy Pharmaceutical Chain Co., Ltd., who drafted the standard.

The other standard, the “Principles for the integrity of pharmaceutical distribution companies” classifies pharmaceutical logistics companies into three levels: A, AA, and AAA based on the scale of logistics distribution, drug quality management capabilities, and drug safety risk control capabilities.

According to Wen Zaixing, the corresponding grade management measures for retail pharmacies and drug distribution companies are expected to be introduced next year.