On September 16, 2021, the CMDE (Center for Medical Device Evaluation) of the NMPA released the draft of Technical Review Guidelines for Qualitative, Quantitative and In Vitro Drug Release Studies on Medical Device-based Combination Products. However, the draft guidelines do not cover the scope of drug-based combination products.
According to the draft guidelines, drug release studies will be required for medical device-based combination products that intend to release the drug components to certain parts of the body such as drug-eluting stents, drug coated balloon catheters, silver dressings, etc. On the other hand, some products with a different intention such as the artificial blood vessels with covalent boding of heparin will not require drug release studies, but can instead carry out in vitro release studies to assess the stability of the product, the firmness of the coating, etc.
The purpose of the qualitative studies is to confirm the test subject to be studied, and ensure that it does not belong to other kinds of irrelevant substance whilst the purpose of quantitative studies is to accurately determine the amount of drug contained in the combination product. The technical specifications for the drug release studies were further addressed in draft guidelines.
The CMDE is solicitating comments from all experts and personnel related to this industry and the public consultation ends on October 15, 2021.
By Dora Yang and Jacky Li. Contact Cisema if you would like to learn more.