Module 3 Presentations

14/05/2024

What is Assessment?

Assessment is a balancing act … risk vs. benefit. • Regulators have a key responsibility to protect public health, by assuring the quality, safety & efficacy of medicinal products. • Regulators have a responsibility not to impose unnecessary burdens on

the pharmaceutical industry, as this may delay the introduction of new medicines with unnecessary costs. Assessment is the process & outcome of a critical review of information, focusing on key aspects that could impact quality, safety & efficacy.

The Organisation for Professionals in Regulatory Affairs

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Medicine-Device Borderline and Classification • Depends on the principal mode of action of the product in the indication • A product is EITHER a medicinal product OR a medical device • The EU and the UK have two sets of legislation and regulatory systems that operate differently

• Combinations of medicines and devices (called drug-device combinations or DDC) are common and provided for in legislation

• For combination products, the two sets of legislation work together but do not duplicate requirements

The Organisation for Professionals in Regulatory Affairs

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