The National Medical Products Administration ("NMPA") has recently formulated and issued the Requirements for Materials and Samples Used in Review Tests of Standards of Overseas New Drugs Urgently Needed in Clinical Treatment (for Chemical Drugs) (the "Requirements") and the Requirements for Materials and Samples Used in Review Tests of Standards of Overseas New Drugs Urgently Needed in Clinical Treatment (for Biological Products), both of which have taken effect immediately from the date of issuance.
According to the Requirements, among eight types of materials requested are "a photocopy of the Acceptance Notice and the original of the Test Notice, issued by the national drug evaluation agency, and a photocopy of the Application Form for Registration of Imported Drugs filled out by the applicant", and applicants are required to submit these materials in both paper and electronic form and have the paper versions affixed with their own official seals. In addition, the Requirements clearly state that samples should be products produced for commercial purposes, and information regarding the samples, such as place of production and packaging materials, should be identical to the information provided in the application for marketing and registering the product. The standard substances (reference products or standard products) necessary for tests and methodological verification should be three times the amount demanded for review tests of standards and for tests performed on imported drugs when they are imported for the first time.