A combination product is a therapeutic or diagnostic product that combines drugs, medical devices, and/or biological products. It combines at least two (02) of these product categories and sometimes even combines all three (03) categories. One of the key growth drivers for this market is the increasing prevalence of chronic diseases such as diabetes, cancer, and cardiovascular diseases. Combination products offer an innovative way of treating these diseases, as they can be delivered directly to the affected area, resulting in more effective treatment. The United States (US) Food and Drug Administration (USFDA) has finalized a guidance document for industry and agency staff on the use of pre-market pathways for combination products, and the lead USFDA center has focused their attention on cross-labeled products.

Other than the USFDA, the EMA also regulates the combination products market. In fact, the Regulatory landscape for combination products is ever evolving, and manufacturers must stay up to date with these changes to ensure compliance and expedite the approval process. This blog will explore some of the future Regulatory trends in the cosmetic products market and their possible impact on the industry.

Streamlining the Regulatory Pathways

In recent years, both the USFDA and EMA have made efforts to streamline the Regulatory pathways for combination products. As mentioned earlier, the USFDA has finalized a guidance document and the lead USFDA center is focused on cross-labeled products.

Similarly, the EMA’s Medical Device Regulation, which came into effect in May 2021, establishes a new Regulatory framework for combination products, with the aim of improving patient safety and facilitating innovation. These Regulatory changes will help manufacturers of combination products bring their products to the market more quickly and efficiently.

Greater Harmonization of Regulations

Both the USFDA and EMA are working towards harmonizing their regulations for combination products to facilitate the international development and approval of these products. In 2019, the agencies signed a Mutual Recognition Agreement (MRA) on inspections of drug manufacturing facilities, which would allow them to recognize the inspections conducted by each other’s Regulatory authorities. This agreement should help reduce duplication of efforts and increase overall efficiency in the Regulatory process. Additionally, the two agencies are collaborating on the development of guidance documents and standards for combination products, which should help harmonize the Regulatory requirements for the products and promote consistency in their evaluation.

The Rise of Combination Product Regulations Outside the US and the EU

As the market for combination products continues to grow, Regulatory bodies across the globe, outside the US and the European Union (EU), are taking notice and developing their own regulations for these products. For instance, in January 2022, the National Medical Products Administration (NMPA), China issued two (02) guidelines to enhance the regulations for the registration of drug-device combination products with clinical value in China and build a management mode suitable for the country. The Therapeutic Goods Administration (TGA), Australia released a guidance document in October 2022 that lays out broad principles for determining which requirements within the Australian Regulatory framework may apply to a certain product, and it also lists a few examples of these boundary products. Health Canada (HC) released a guidance document titled “Classification of Products at the Drug-Device Interface” in July 2021 to improve consistency, predictability, and transparency in the stakeholders’ decision-making process on classification. The classification of a health product is crucial since it determines which set of regulations will be applied to it. Manufacturers of combination products should be aware of the emerging Regulatory frameworks and ensure compliance with local regulations in the respective markets.

The Impact of the Trends on Manufacturers and the Industry

The streamlining of Regulatory pathways would allow manufacturers to bring their products to the market faster and with more efficiency, while a greater harmonization of regulations should help reduce Regulatory burden, optimize costs, and increase consistency in the evaluation of these products. However, the rise of combination product regulations outside the US and the EU may present newer Regulatory challenges for manufacturers seeking to expand into these markets.


In conclusion, the Regulatory landscape for combination products is evolving, and manufacturers must stay up to date with these changes to ensure compliance and expedite the approval process. The trends of increased emphasis on the streamlining the Regulatory pathways, greater harmonization of regulations, and the rise of combination product regulations outside the US and the EU are expected to have a significant impact on manufacturers and the industry at large.  

Do you want to know more about the ever-changing Regulatory landscape for combination products? Schedule a meeting with us and we will help you navigate the complexities. Stay informed! Stay compliant!



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