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Centralised Procedure

EMEA proposes time limits for applicants' response to questions

Companies applying for marketing authorisation through the European Union's centralised procedure will have three months to respond to the list of questions set by the European Medicines Agency's (EMEA's) Committee for Medicinal Products for Human Use (CHMP). This stipulation is set out in a new guidance released by the EMEA in response to an identified lack of rules governing how long applicants may take to respond to questions raised during the evaluation process.

By law, the evaluation of centralised marketing authorisation applications must take no longer than 210 days. After day 120 of...

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