The State Administration for Market Regulation ("SAMR") has recently released the Decision on Adjusting Approval Items Concerning the Administration of Preparations of Medical Institutions (Draft for Comment) (the "Draft for Comment") to seek public comments by August 18, 2018.
The Draft for Comment, comprising ten articles, covers the scope of cross-provincial allocation, procedures to apply for examination and approval, responsibilities of each medical institution concerned during each process, regulatory duties of the provincial drug regulators concerned, and required materials. In terms of procedures to apply for examination and approval, among others, the Draft for Comment expressly states that, an applicant for the cross-provincial allocation must be a medical institution (the "entity offering preparations") holding the approval document number or record-filing number issued for preparations of medical institutions and the application shall be filed by such entity to the provincial drug regulator of the place where it is located. Where the application is approved upon examination, the user (the "entity receiving the offered preparations") shall submit the examination opinions and relevant materials to the provincial drug regulator of the place where it is located which will then decide whether to approve it or not.