Professional drug-inspection teams to be established

2019-07-18

The State Council issued a circular on July 18 outlining measures to form professional drug-inspection teams, as part of efforts to strengthen drug supervision and guarantee drug safety.

According to the circular, drug inspectors will be recognized by drug authorities and authorized to conduct compliance verification and risk judgment on places where drugs are developed and produced, as well as ensure that drugs are produced in accordance with laws and regulations.

The drug teams will be established by 2020 at both national and provincial levels, the circular said, with an emphasis on high-risk drugs like vaccines.

The circular also determined the division of power and responsibilities for both teams.

Drug-inspection teams under the State Council drug regulatory department will be responsible for onsite inspections on the research and development of drugs, medical equipment, and cosmetics for special use.

These teams will also be responsible for overseas inspections and targeted inspections of drugs, medical equipment and cosmetics.

Provincial teams will meanwhile conduct onsite inspections on the production of drugs, medical equipment, and cosmetics. They will also inspect pharmaceutical wholesale enterprises, headquarters of retail chains, as well as third-party online sales platforms, and provide guidance for regulatory departments at county level.

Rules and process specifications for drug inspection should be further improved, and a national unified database and information platform should be established for drug inspectors at different levels to share information.

To safeguard drug inspectors’ fundamental rights and to encourage their potential, a reasonable mechanism for salary and welfare, performance evaluation and title assessment will be adopted.

Vocational training will also be strengthened to develop high-quality inspectors, the circular said.

(Reprinted from ENGLISH.GOV.CN, for reference only)