What are the differences (in terms of objective, timing…) between conditional MA and MA under exceptional circumstances? Is there any other form of MA (besides the standard one)?
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Conventional/standard regulatory pathways to the MA may not be appropriate, due to the fast rate of spread and severity of the disease or the difficulty, owing to the rarity of the pathology, to enroll enough patients in clinical trials to provide robust clinical evidence.
In this context, the EMA has developed 2 other regulatory pathways: conditional MA and MA under exceptional circumstances. They are fast-tracking to ensure patients’ access to essential treatments, preserving the initial positive benefit-risk balance (comprehensive data cannot be provided).
Besides, there are tools that allow early access to medicines (faster route, but do not represent a separate MA pathway): like compassionate use, PRIME Program, accelerated assessment and rolling review.
Hope my answer is useful!
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The MA under exceptional circumstances provides a route for medicines to be authorised when comprehensive clinical data cannot be provided, and it is granted in cases where full clinical data cannot be obtained for objective and verifiable reasons.
Differently from this latter, the conditional MA is not meant to remain conditional indefinitely, but it is to be converted into a non-conditional authorisation as soon as comprehensive clinical data are available. Medicines can be authorized although clinical data might not be provided completely at the time of submission of the dossier. This MA form is converted into standard MA after an agreed timeframe, under penalty of withdrawal of the product from the market.
Sources:
https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/conditional-marketing-authorisation#:~:text=Unlike%20conditional%20marketing%20authorisation%2C%20where,be%20obtained%20even%20after%20authorisation.
https://www.sciencedirect.com/science/article/abs/pii/S0378517323006130
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