The diagnostic products, including drugs, devices, and biological products, are commonly referred to as Combination drug products. Combination products generally contain components that are typically regulated by different types of regulatory authorities. These products also face different kinds of challenges by various FDA centers regarding regulation, policy, and review management. The regulatory processes can impact the development and management of a combination drug product.
There are some specific guidelines and processes which have to be followed for the combination of drug product development. First of all, the PMOA of the product should be mentioned clearly and accurately. There were 67 requests for RFD or requests for designation of a combination product during the five years between 2009 and 2014. 69% of those requests were found to be insufficient with the information provided by the sponsors.
The manufacturers should also be aware of global regulatory guidelines about a combination product. In the USA, there is a regulating body that looks over all the combination product requests, which is the FDA. However, in the other parts of the world, there is no centralized decision-making bodies. Before launching a combination drug product in foreign continents like Europe or Asia, these facts should be known beforehand by a sponsor.
There should be a balance on the cGMP quality of a drug. In maximum cases, the cGMP manufacturing strategy of the FDA does not sync with the combination of drug product development. Even the slightest of the deficiencies of the combination products like design controls, change controls, or purchasing controls can be vital for your products, and the FDA may not approve the product. This is why; there is a need for a Quality Management System for all the sponsors and product manufacturers.
Before launching any combination drug product in the market, a sponsor should always calculate the risks and make decisions based on that. A well-devised risk management strategy will show all the deficiencies and constitute the combination product as a whole.
In many countries, there is a deficiency of trustworthy organizations for approving the combination of drug product development. This is why; the sponsors and producers have to develop a combination product carefully and have to follow a clear-cut guideline. Maintaining a cGMP manufacturing strategy, establishing a QMS within would be very helpful for a sponsor and save both the time and money of the sponsor.