The amendments on data requirements in China’s New Substance Notification Guidance were published on Aug 28th 2017 as an individual announcement (MEP Announcement No.42 of 2017), rather than being published as part of the full document of the revised Guidance. The amendments took effect from Oct 15th 2017.
The revised data requirements consist of the following part:
Annex 1. Minimum requirements of toxicological data
Annex 2. Minimum requirements of eco-toxicological data
Annex 3. Exemption conditions of physico-chemical data
Annex 4. Exemption conditions of toxicology testing data
Annex 5. Exemption conditions of eco-toxicology testing data
Original regulatory document