Chinese regulator to inspect drug makers

The State Food and Drug Administration (SFDA)’s implementation plan requires that provincial drug regulatory departments carry out a full investigation of manufacturers of drug raw materials and drug preparations in their jurisdictions.

Manufacturers that produce injections, have products that have been complained about, have products listed as substandard in drug quality announcements in the past two years or have not undergone follow-up inspection or other inspections in the past two years are highlighted in the SFDA’s plan.

The key inspection areas will include quality assurance departments, quality control departments, and material management. Other areas such as production control, drug distribution, and adverse reaction reports will also be central to the inspection, as will punishment for violating Drug Administration Law and other related regulations and laws.