On August 18th, the CFDA official website explained the relevant matters regarding the released reference formulations, clarifying the following points:
1、 Products supplied by different licensees (limited to European, American, and Japanese enterprises) under the same parent company and produced by the same manufacturer can be considered equivalent.
2、 Products supplied by different licensees not under the same parent company and produced by the same manufacturer can be considered equivalent if appropriate evidence can be provided to prove that the prescriptions, production processes, and product quality of products from different licensees are the same.
3、 Products supplied by the same licensee and listed in the European Union from different origins can be considered equivalent if appropriate evidence can be provided to prove that the prescription, production process, and product quality of products from different origins are the same; Otherwise, it is generally not considered equivalent, and the place of origin in the reference formulation catalog shall prevail.
4、 Due to the possibility of multiple reference formulations for sustained-release and controlled release formulations, the expert review meeting for reference formulation selection will only review the registered varieties of the enterprise to confirm whether the registered reference formulation can be used as a reference formulation. This reference formulation may not be applicable to other enterprise products, and if not, it can be filed separately.
