Specifications for record data of toothpaste released by national medical products administration (NMPA) (exposure draft)

Recently,NMPA issued the Specifications for Record Data of Toothpaste (exposure draft) and solicited the public opinions.This specification involves 51 articles which clarified the subject,method and materials to be submitted for record.Just less than two months ago,the Regulations on the Toothpaste Supervision (exposure draft) was introduced by NMPA.The draft paper also defines the rights and responsibilities of record people,namely,the person who take responsibility for record.As mentioned in the draft,the toothpaste record person shall take legal responsibilities accordingly for the authenticity,legality and comprehensiveness of the record materials.Also,the record person overseas shall supervise the record work done by domestic person in charge.

Enterprises which conducts toothpaste record for the first time shall submit the information of record person and the resume of person in charge of quality and safety; profile of quality management system of record person; negative response supervision and evaluation system profile of record person,etc.It resembles the requirement made in the Cosmetics Registration and Record Information Specifications(exposure draft).Viewed from the perspectives of the negative response supervision and evaluation system profile,foundation of naming,product formula,it “is basically in line with the cosmetic record” as broadly commented by the insiders.

Besides,for those products with labels as“joint research”,“development”,“production and supervision” of other enterprises or institutions,the draft also requires businesses to submit the commitment letter of responsibility for product quality and safety issued by such enterprises or institutions,which shall be signed and sealed by such enterprises or institutions for confirmation.