The National Medical Products Administration (NMPA) has issued an announcement regarding the development of generic drugs without a reference preparation, titled “Announcement on the Development of Generic Drugs with No Reference Preparation (No. 130 of 2023).” This new guideline addresses the process for drugs lacking a reference for generic quality consistency equivalency (GQCE) reference preparation varieties, allowing applicants to conduct generic research if the drug is evaluated to have expected clinical value.
Criteria for Generic Drug Development
According to the announcement, generic varieties should align with current scientific understanding and meet clinical diagnosis and treatment needs and practices. They should be widely used as mainstream drugs and possess irreplaceable characteristics. Additionally, there must be sufficient clinical trial data to demonstrate that the clinical benefits outweigh the risks. Applicants are required to conduct generic research based on current technical requirements and perform a comprehensive quality assessment of similar drugs already on the market.
Quality Standards and Communication Process
The quality of generic drugs must not fall below that of marketed varieties with substantial research, a solid marketing foundation, or a significant market share in the corresponding disease field. Applicants intending to replicate non-reference preparation varieties must fully evaluate their expected clinical value and submit a communication and exchange application (Class III) to the Drug Evaluation Center (CDE) along with relevant research materials.
Alignment with International Standards
Following the reform of the drug review and approval system, China has established a registration system and technical evaluation system for chemical generic drugs that align with international standards. This means that chemical generic drugs should match the quality and efficacy of the originators. An originator is defined as the first drug approved for marketing both domestically and internationally, supported by complete and sufficient safety and efficacy data. In principle, the reference preparation list should include the originator variety, and applicants for generic drugs should select varieties from the reference preparation list published by the national drug regulatory department for their generic research.-Fineline Info & Tech
