Module 18 2021

07/02/2021

DRUG DEVICE COMBINATIONS

How do these medicinal substances fit with combination products: • Integral • Pre-filled syringe • Inhaler Registration as a medicine, but device must conform to device standards (CE Mark)

• Separate • Vial of drug sold with empty syringe Each is subject to registration by their respective system

• Ancillary Drug • Anticoagulant coated catheter Registration as a device, but drug must conform to medicines standards

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Development of a Medicine

Establishment of Quality, Safety and Efficacy • Pharmaceutical quality • Consistently produce the same product with the same characteristics and performance • Non-Clinical Safety • Animal studies to understand how the product behaves and establish safe levels of dose and impurities • Clinical Efficacy and Safety • Human studies, Phase 1-3; first in healthy volunteers (usually) to confirm safety, then dose establishment in patients, and then efficacy and safety in patients

The Organisation for Professionals in Regulatory Affairs

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