CFDA issues final revisions to Drug Quality Management Standards | Practical Law

CFDA issues final revisions to Drug Quality Management Standards | Practical Law

The CFDA issued a revised version of the Drug Quality Management Standards. The versions mainly focus on requiring pharmaceutical companies to establish and implement traceability systems for pharmaceutical products.

CFDA issues final revisions to Drug Quality Management Standards

Practical Law UK Legal Update 9-631-9785 (Approx. 3 pages)

CFDA issues final revisions to Drug Quality Management Standards

by Practical Law China
Published on 05 Aug 2016 • China
The CFDA issued a revised version of the Drug Quality Management Standards. The versions mainly focus on requiring pharmaceutical companies to establish and implement traceability systems for pharmaceutical products.
On 13 July 2016, the China Food and Drug Administration (CFDA) issued the Decision to Revise the "Drug Quality Management Standards" (国家食品药品监督管理总局关于修改《药品经营质量管理规范》的决定), with immediate effect. These standards, commonly known in the industry as "good supply practices" (GSP), were first issued by the Ministry of Health (MOH) in 2013 and updated by the CFDA in July 2015.
This decision partially modifies draft revisions to the Drug Quality Management Standards circulated in February 2016, and brings the standards into conformity with the State Council’s Opinions on Accelerating the Construction of an Important Product Traceability System 2015(国务院办公厅印发《关于加快推进重要产品追溯体系建设的意见》).
The final version includes the following changes:
  • Adding or revising provisions requiring pharmaceutical companies to establish and implement traceability systems for pharmaceutical products (Articles 2, 36(21), 57, 135, 138(17), 146 and 181).
  • Revising provisions requiring pharmaceutical companies to electronically monitor pharmaceutical products and data uploads (Articles 84 and 161).
  • Adding the qualifications requirements for the personnel of pharmaceutical companies that transport vaccines (Article 22(2)).
  • Clarifying the equipment requirements for companies engaged in the storage or transportation of pharmaceutical products that must be refrigerated or frozen (for example, vaccines storage must be equipped with at least two independent freezers) (Article 49).
  • Adjusting the supporting documents of newly-established enterprises for examination purposes to reflect the requirements under China's new "three in one" business registration system (Article 62).
  • Clarifying that violations of the GSP standards will be punished in accordance with Article 78 of the Drug Control Law of the People’s Republic of China 2015 (Article 183).
For information on draft revisions to these standards, see Legal update, CFDA circulates revisions to Drug Quality Management Standards.
Source: CFDA website: Decision of the China Food and Drug Administration to Revise the Drug Quality Management Standards (国家食品药品监督管理总局关于修改《药品经营质量管理规范》的决定)