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WHO Drug Information Vol. 31, No. 3, 2017Regulatory newsRegulatory news
Premarket assessment of adverse events in relation to stopping a
trial or progressing to the next dosing level. Strategic approach
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What is pre-market assessment?
Pre-market assessment is a process of evaluating a product's safety and effectiveness before it is launched in the market.
Who is required to file pre-market assessment?
Manufacturers, distributors, or importers of products are required to file pre-market assessment.
How to fill out pre-market assessment?
Pre-market assessment can be filled out by providing detailed information about the product, its intended use, potential risks, and any available safety data.
What is the purpose of pre-market assessment?
The purpose of pre-market assessment is to ensure that the product meets regulatory requirements and is safe for consumer use.
What information must be reported on pre-market assessment?
Information such as product specifications, manufacturing processes, labeling, packaging, and any relevant test data must be reported on pre-market assessment.
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