A different centre regulates each of the entities mentioned above products within the Agency. Each of these centres is subject to its own set of legal and regulatory and own administrative and organizational review structure. The Center for Biological Evaluation and Research regulates biological products (CBER). The Center for Drug Evaluation and Research is in charge of drug regulation (CDER). The Center for Devices and Radiological Health regulates the devices (CDRH). Depending on the specific HCT/P, HCT/Ps may be regulated by CBER as drugs or biological products, or as “361 products” or by CDRH as devices.
The market for combination drug products, in particular, has expanded dramatically. According to Research and Markets data from 2018, the global market is expected to exceed $177 billion by 2024.
What is a combination drug product?
A combination product combines drugs, medical devices, and biological products for therapeutic or diagnostic purposes. A combination product will include at least two, and in some cases, all three of these product categories. Combination products from conventional drug devices, such as a pre-filled syringe with medication, and packaged or prepackaged products, such as a first aid kit containing bandages and pain-relieving medications, are two of the most common types.
As pharmaceutical, medical technology, biotechnology, and life sciences companies continue to innovate, the market for composite products expands.
The staff of the combination drug product
As expected, each of the centres has access to the staff and expertise associated with the structured products. In the case of combination products, this institution within a single centre is insufficient to address all legal, regulatory and scientific concerns. Issues associated with combination products transcend organizational and scientific boundaries between centres. To address the kinds of complex issues associated with composite products, Congress and the Agency have determined that it is necessary to create a group responsible for addressing the unique challenges associated with composite products.
Conclusion
These products that help with drug delivery can be extremely beneficial to patients. Drug delivery devices that enable easier self-dosing, such as a single-use prefilled syringe containing a single dose of a drug, can, for example, help reduce patient dosing errors and increase compliance. Injection systems and pulmonary inhalers currently dominate the market for combination drug delivery products.
