Combination products are products that are composed of a combination of a drug a medical device and/or a biological product. A combination product will consist of at least two of these constituent parts.
They are regulated by both the pharmaceutical and medical device agencies. The regulatory pathway for combination products is complex and varies by region. In the United States, depending upon the primary mode of action (PMOA) combination products are regulated by the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH). In the European Union, combination products are regulated by the European Medicines Agency (EMA) and the Medical Devices Directive (MDR).
The importance of the right services for clients in the CMC regulatory affairs combination products landscape is further highlighted by the growing complexity of these products and the increasing regulatory scrutiny they face. As combination products become more sophisticated, so do the challenges associated with their development and regulatory approval. The bio-pharmaceutical and medical devices companies seek industry experts to navigate through the complex regulatory landscape to ensure the successful development and timely commercialization of their combination products.
As the demand for combination products continues to grow, the regulatory landscape is likely to evolve. The bio/pharmaceutical and medical device agencies are working together to develop harmonized guidelines for combination products. These guidelines are designed to streamline the regulatory process and make it easier for companies to develop and bring combination products to market.