("NEW STANDARDS")(新修订《药品经营质量管理规范), ISSUED BY THE MINISTRY OF HEALTH ("MOH")

After three rounds of public consultation, MOH finally enacted the amended GSP standards, regulating all pharmaceutical distribution and introducing stricter requirements for pharmaceutical wholesalers and retailers than the previous version published in 2000.

The New Standards explicitly requires pharmaceutical distributors to establish a quality control system and virtually set up a quality control department to make sure quality control policies are implemented efficiently. A comprehensive quality control system shall consist of the following factors

  • Pharmaceutical distributor’s personnel shall meet certain education, license and professional experience requirements, which the New Rules have specified in detail.
  • Pharmaceutical distributor shall carry out archive management, keeping files on the quality of management, responsibilities of various departments and positions, routine practice, profiles, reports and certificates.
  • Pharmaceutical distributor shall have business premises, storeroom and logistics suitable for the scope and scale of its business. The storage of different types of pharmaceutical products, such as frozen medications and Chinese medications must meet specific facility requirements established in the New Standards.
  • Pharmaceutical distributor shall be equipped with a computer system to supervise the pharmaceutical products electronically, including digital applications, network devices and databases for this computer system.

The New Standards are enacted with the objective of rectifying the pharmaceutical distribution industry. The tighter requirements will oblige most existing pharmaceutical distributors to upgrade their facilities and personnel to comply with these standards, which may impose a greater financial burden on them. As expected, a large number of small-scale distributors will be forced to leave the market due to financial embarrassment.

Date of issue: January 22, 2013. Effective date: June 1, 2013.