3
As part of the MAA review, the Pharmacovigilance Risk Assessment Committee
(PRAC) will assess and recommend risk management and post-approval actions
intended to help mitigate or manage adverse events. The PRAC assessment report
will be included as part of CHMP assessment and within the final opinion on
an MAA.
CAT at the EMA has a similar role to the CHMP, but is responsible for assessing the
quality, safety, and efficacy of advanced therapy medicinal products (ATMPs). As
needed, the CHMP will also collaborate with other committees like the Paediatric
Committee (PDCO), the Committee for Orphan Medicinal Products (COMP), and
other working parties to fulfill other important roles related to the authorization of
medicines in the EU.
Enigmatic EMA
Unlike the US Food and Drug Administration (FDA), which runs very public
meetings, CHMP meetings happen behind closed doors. This, combined with
a lack of public transcripts, makes it very difficult for companies to find out
how applicants for previous MAAs have resolved similar issues. The CHMP
does publicly share the assessment report for each positive opinion that leads
to marketing authorization in the European Public Assessment Report, but
these documents lack information on the critical details that identify what the
committee’s concerns were, or how issues or negative opinions were resolved.
As part of the MAA review, the Pharmacovigilance Risk Assessment Committee
(PRAC) will assess and recommend risk management and post-approval actions
intended to help mitigate or manage adverse events. The PRAC assessment report
will be included as part of CHMP assessment and within the final opinion on
an MAA.
CAT at the EMA has a similar role to the CHMP, but is responsible for assessing the
quality, safety, and efficacy of advanced therapy medicinal products (ATMPs). As
needed, the CHMP will also collaborate with other committees like the Paediatric
Committee (PDCO), the Committee for Orphan Medicinal Products (COMP), and
other working parties to fulfill other important roles related to the authorization of
medicines in the EU.
Enigmatic EMA
Unlike the US Food and Drug Administration (FDA), which runs very public
meetings, CHMP meetings happen behind closed doors. This, combined with
a lack of public transcripts, makes it very difficult for companies to find out
how applicants for previous MAAs have resolved similar issues. The CHMP
does publicly share the assessment report for each positive opinion that leads
to marketing authorization in the European Public Assessment Report, but
these documents lack information on the critical details that identify what the
committee’s concerns were, or how issues or negative opinions were resolved.