China Laws and Regulations Update in February 2019

1. Announcement on Publishing the Regulations on Overseas Inspection of Medicine and Medical Instruments

Promulgated by the State Administration for Market Regulation

Document number: No.101 in 2018 by the State Administration for Market Regulation

Promulgation date: 26 December 2018

Effective date: 26 December 2018

The Announcement states that overseas inspections are conducted for medicine and medical instruments that have been marketed or are proposed to be marketed and that overseas inspections do not only include inspections in places where production is being performed but mean inspections in places where research, development or production is being performed. Matters to be investigated are decided by considering risks in registration, supervision, examination, inspection, reporting, adverse effect, etc. of medicine and medical instruments as required for risk control. (Source: Website of the State Administration for Market Regulation)