Poor predictability relating to the number of drug marketing authorization applications (MAAs) that are expected to be submitted for evaluation via the EU centralized procedure is taking a toll on regulatory assessors working at the national competent authorities (NCAs) in EU member states.
Key Takeaways
- Frequent postponements and last-minute withdrawals of planned marketing authorization applications due for evaluation through the EU centralized procedure are negatively impacting assessors at EU national...
A sizeable number of planned MAAs are often postponed by companies multiple times or are withdrawn altogether, resulting in NCAs who are granted rapporteurships/co-rapporteurships to lead the scientific evaluation of...
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