The Center for Drug Evaluation (CDE) has released a Notice on the “Generic Study for Varieties with no Reference Preparations” (draft proposal), outlining the filing material and technical requirements for such products. This move aims to address the unique historical legacy issue in the development process of generic drugs in China.
Classification and Definition of Chemical Generic Drugs
The document highlights that following the reform of drug registration classification in China, chemical generic drugs have been classified and defined. Generic versions can be selected based on the registration classification and technical requirements of chemical generic drugs, and originators in the reference preparation list can be chosen for quality and efficacy consistency research.
Challenges with Non-Reference Preparation Varieties
Some varieties launched earlier and imitated from non-original drugs cannot achieve quality and efficacy consistency evaluation with original drugs due to incomplete and insufficient safety and efficacy data, low product quality, lack of evidence-based medical evidence, and questionable clinical value. These non-reference preparation varieties pose a unique challenge in the generic drug development process in China.
Clinical Demand and Classification of Basic Infusions
There is a clinical demand for basic infusions such as glucose injection, sodium chloride injection, vitamins, and nutritional drugs. Although there is no concept of an originator drug for these varieties, they can still be classified based on whether the product has been launched domestically or internationally and declared according to the existing generic drug registration classification (3/4/5.2 categories).
Substitution or Elimination of Varieties
Facing the issue of substitution or elimination, there is a debate on the necessity of replicating these varieties. In light of this, CDE will not release a chemical drug list that cannot recommend reference preparations, focusing on ensuring that only those with clinical value and the potential for quality and efficacy consistency are advanced in the registration process.-Fineline Info & Tech
