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FDA Commissioner Scott Gottlieb has been promoting drug market competition in recent months that includes new guidance documents and targeted advisories to support R&D of complex drugs and combination products.
FDA Commissioner Scott Gottlieb has been promoting drug market competition in recent months that includes new guidance documents and targeted advisories to support R&D of complex drugs and combination products. A revised draft guidance discusses studies to evaluate the adhesive performance of proposed generic transdermal and topical delivery systems (TDS) products. A second guidance discusses studies to evaluate in-vivoskin irritation and sensitization potential of such treatments. FDA also has issued 235 product-specific guidance documents on the appropriate methods for developing specific generic TDS products (1).
In Europe, the European Medicines Agency (EMA) has pharmaceutical companies concerned after the agency announced it was slowing down work on certain guidelines due to Brexit. The industry has been waiting for a guideline on the assessment of device components in combination products under the European Union’s Medical Devices Regulation (MDR), which requires drug-device components in integral drug-device combinations (DDCs) to be evaluated by notified bodies. The process for this is still unclear, and some companies are worried this guideline delay will affect marketing authorization of integral DDCs, which range from pre-filled syringes to complex electro-mechanical devices (2).
EMA, however, has assured industry that work on the MDR guideline will continue. In an interview with Pharmaceutical Technology Europe, an agency spokesperson stated: “EMA is aware of the concerns raised by the industry that came with the introduction of the new MDR, and in particular with Article 117 (requiring an NB opinion on combination products) … Work on seven guidelines which address either an urgent public/animal health need or are necessary to support and facilitate preparation for Brexit or the implementation of new or revised legislation will continue beyond Nov. 1, 2018. This includes the guideline on quality requirements of medicinal products containing a device component for delivery or use of the medical product” (2).
1. J. Wechsler, “FDA Promotes Complex Generics and Combination Products,” PharmTech.com, Oct. 19, 2018, www.pharmtech.com/fda-promotes-complex-generics-and-combination-products-0
2. S. Milmo, Pharmaceutical Technology Europe30 (11) 2018.
Vol. 42, No. 12
When referring to this article, please cite it as S. Haigney, “Regulatory Developments in Combination Products," Pharmaceutical Technology 42 (12) 2018.