6 Guidelines To Follow When Developing Combination Products

By Winston Brown, VP of Global Quality, Phillips-Medisize

While the development of a combination product comes with significant patient benefits through technology and molecule innovation, that reward can be offset by the range of regulatory complexity and uncertainty encountered with bringing a product to market, in addition to any post-marketing activities. The area of combination products is still unique to many regulatory authorities abroad, wherein the lines are often blurred when it comes to product classification and jurisdiction. While the regulatory path and compliance requirements may be fairly clear in one country, there are no universal templates, procedures, or exacting opinions to follow for harmonized solutions. Combination products have the potential for significant therapeutic advantages over traditional dosage forms of medicine by delivering value and convenience for both patient and point-of-care provider, maintaining dosage compliance, and providing novel drug-delivery therapies for unmet medical needs.