About this Research Topic
Combination products are medical products that combine two or more different product types, including drugs, devices, or biological products, into a single entity. These products are increasingly prevalent and pose unique regulatory challenges that require a comprehensive understanding of the regulatory framework governing them. Due to the combination of more than one active ingredient to treat, cure or mitigate disease and/or disease like conditions. Combination products are recognized amongst the most challenging products to develop in the medical drug and device industry. These products are challenging because as they often have different regulatory pathways and requirements, depending on the specific components involved.
When innovative technologies, such as wearables, artificial intelligence, virtual reality, and augmented reality are combined with drugs and devices, the complexity of these challenges increase even further. For example, wearable medical devices carry their own set of regulatory requirements related to safety and efficacy, while the active ingredients in drug and biologics have their own regime of safety and effectiveness. These regulatory requirements vary when manufacturers attempt to combine both regime into one.
While the challenges of dealing with combination products remain on the horizon, the challenges with regulatory agencies globally are no less easier when ensuring that the safety and efficacy of these products are within the established requirements for finished products. In the United States, the FDA's Center for Devices and Radiological Health (CDRH) regulate medical devices, while the Center for Drug Evaluation and Research (CDER) regulate drugs, also the Center for Biologics Evaluation and Research (CBER) regulate biologics. Depending on the specifics of the products, all three centers of the FDA collaborate to support innovation in the medical field, while the Office of Combination Products (OCP) assign combination products to FDA’s medical product centers for review to develop guidance, regulations and standard operating procedures to clarify combination product regulation. In addition, combination products which include active pharmaceutical or biologics undergoes review by respective centers of FDA, which can be challenge to ensure a timely review of the final product.
In Europe the European Medicines Agency (EMA) is responsible for evaluating the quality, safety and efficacy of marketing authorization applications assessed through the centralized procedure. The medicinal products used in combination with medical devices are under the EU Pharmaceutical legislation (Directive 2001/83/EC or Regulation (EC) No. 726/2004. The device in these type of combination products would require a conformity assessment.
Similarly, Health Canada policies determine if a product will subject to either medical device regulations or food and drug regulations based on the principal mechanism of action by which the claimed effect of purpose is achieved. Regardless of regulations, Health Canada ensures both that the principal and ancillary components are meet the acceptable standards of quality, safety and efficacy.
In 2014 the Japanese Pharmaceuticals and Medical Device Agency (PMDA) issued a notice “Handling of Marketing Application for Combination Products” which clarified the regulatory scope of combination products in Japan. Similarly, China’s National Medical Products Administration (NPMA) released the “Registration Guideline on Combination Products with Device as Primary Mode of Action” in 2022 directing manufacturers for safety and efficacy evaluation of combination products.
Based on the thrust areas as mentioned below, this Research Topic aims to explore and provide expert viewpoints on technical and regulatory challenges of combination products in medical device and drug industry. We intend to invite contributors to submit their original research articles, review papers, and case studies that provide new insights, perspectives, and approaches to address the regulatory challenges of combination products. In addition, we’ll welcome individual contributor’s opinion as opinion letters in this area. We anticipate this Research topic will provide a valuable platform for industry professionals, regulatory, and healthcare providers who are seeking information on a broader spectrum of combination products.
Thrust Areas
Regulatory strategies for combination products
Comparing regulatory pathways on global and regional basis
Scientific and technical considerations for combination products
Challenges in the development and approval of combination products
Post-marketing regulatory requirements for combination products
Global harmonization of regulatory requirements for combination products and cross refer review reports from different health authority.
Emerging trends and technologies in the regulation of combination products
Combination products and drug-device interoperability
Regulatory considerations for combination products using artificial intelligence (AI)
Safety and efficacy of combination products
Combination products in personalized medicine
Combination products in clinical trials
Labeling and advertising requirements for combination products
Intellectual property and patent considerations for combination products
Ethics considerations for combination products
Combination product classification globally drug-drug and drug device model.
When innovative technologies, such as wearables, artificial intelligence, virtual reality, and augmented reality are combined with drugs and devices, the complexity of these challenges increase even further. For example, wearable medical devices carry their own set of regulatory requirements related to safety and efficacy, while the active ingredients in drug and biologics have their own regime of safety and effectiveness. These regulatory requirements vary when manufacturers attempt to combine both regime into one.
While the challenges of dealing with combination products remain on the horizon, the challenges with regulatory agencies globally are no less easier when ensuring that the safety and efficacy of these products are within the established requirements for finished products. In the United States, the FDA's Center for Devices and Radiological Health (CDRH) regulate medical devices, while the Center for Drug Evaluation and Research (CDER) regulate drugs, also the Center for Biologics Evaluation and Research (CBER) regulate biologics. Depending on the specifics of the products, all three centers of the FDA collaborate to support innovation in the medical field, while the Office of Combination Products (OCP) assign combination products to FDA’s medical product centers for review to develop guidance, regulations and standard operating procedures to clarify combination product regulation. In addition, combination products which include active pharmaceutical or biologics undergoes review by respective centers of FDA, which can be challenge to ensure a timely review of the final product.
In Europe the European Medicines Agency (EMA) is responsible for evaluating the quality, safety and efficacy of marketing authorization applications assessed through the centralized procedure. The medicinal products used in combination with medical devices are under the EU Pharmaceutical legislation (Directive 2001/83/EC or Regulation (EC) No. 726/2004. The device in these type of combination products would require a conformity assessment.
Similarly, Health Canada policies determine if a product will subject to either medical device regulations or food and drug regulations based on the principal mechanism of action by which the claimed effect of purpose is achieved. Regardless of regulations, Health Canada ensures both that the principal and ancillary components are meet the acceptable standards of quality, safety and efficacy.
In 2014 the Japanese Pharmaceuticals and Medical Device Agency (PMDA) issued a notice “Handling of Marketing Application for Combination Products” which clarified the regulatory scope of combination products in Japan. Similarly, China’s National Medical Products Administration (NPMA) released the “Registration Guideline on Combination Products with Device as Primary Mode of Action” in 2022 directing manufacturers for safety and efficacy evaluation of combination products.
Based on the thrust areas as mentioned below, this Research Topic aims to explore and provide expert viewpoints on technical and regulatory challenges of combination products in medical device and drug industry. We intend to invite contributors to submit their original research articles, review papers, and case studies that provide new insights, perspectives, and approaches to address the regulatory challenges of combination products. In addition, we’ll welcome individual contributor’s opinion as opinion letters in this area. We anticipate this Research topic will provide a valuable platform for industry professionals, regulatory, and healthcare providers who are seeking information on a broader spectrum of combination products.
Thrust Areas
Regulatory strategies for combination products
Comparing regulatory pathways on global and regional basis
Scientific and technical considerations for combination products
Challenges in the development and approval of combination products
Post-marketing regulatory requirements for combination products
Global harmonization of regulatory requirements for combination products and cross refer review reports from different health authority.
Emerging trends and technologies in the regulation of combination products
Combination products and drug-device interoperability
Regulatory considerations for combination products using artificial intelligence (AI)
Safety and efficacy of combination products
Combination products in personalized medicine
Combination products in clinical trials
Labeling and advertising requirements for combination products
Intellectual property and patent considerations for combination products
Ethics considerations for combination products
Combination product classification globally drug-drug and drug device model.
Keywords: Combination Products, regulatory pathways, Product development, regulatory requirements
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