The National Medical Products Administration ("NMPA") has recently drafted and issued the Technical Requirements for Consistency Evaluation for Quality and Efficacy of Generic Chemical Injections (Draft for Comment) (the "Draft for Comment") and the Requirements for Application Materials for Consistency Evaluation of Quality and Efficacy of the Marketed Generic Chemical Injections (Draft for Comment) for public comment by November 15, 2019.
The Draft for Comment states that an applicant shall gain a comprehensive understanding of the marketing background at home and at broad for the already marketed injections, their safety and efficacy data, and post-marketing adverse reactions that have been detected, and evaluate and confirm their clinical value. Meanwhile, the Draft for Comment requires that an applicant shall, pursuant to the Procedures for Selection and Determination of Reference Listed Drugs of Chemical Generic Drugs released by the NMPA, select the reference listed drugs, and carry out consistency evaluation by reference to these technical requirements and under the relevant domestic and foreign technical guidelines. Moreover, the Draft for Comment provides for technical requirements for the formulation, technical requirements for quality control for bulk pharmaceutical chemicals, pharmaceutical excipients and packaging materials, technical requirements for quality research and control, among others.