2
Serving Europe
The EMA was founded in 1995 and is responsible for assessing the efficacy,
safety, and quality of all medicines for Europe’s 500 million citizens. It serves 27 EU
member states plus Iceland, Liechtenstein, and Norway, which are in the European
Economic Area.1 Importantly, its decisions may also influence the UK’s Medicines
and Healthcare products Regulatory Agency (MHRA).
Within the EMA, there are seven scientific committees and several working groups
that evaluate the benefit-risk profiles of medicines for both humans and animals.
The Committee for Medicinal Products for Human Use (CHMP) and Committee
for Advanced Therapies (CAT) are arguably the most pivotal committees as these
committees ultimately determine whether a medicine is safe, effective, and of a
high enough quality to be approved for use in humans. The CHMP and CAT are
each made up of one member from each EU member state plus five co-opted
members who are chosen because of their specific scientific competence.
Once a company, also known as the applicant, has submitted its Marketing
Authorization Application (MAA) the CHMP carries out the initial assessment of
the application. During the process, the CHMP raises questions and may ask the
applicant to provide clarifications or additional analyses.
If the CHMP believes the benefits of a medicine outweigh the risks, it will
recommend to the European Commission that the applicant receive a marketing
authorization for its product.
The CHMP’s scientific opinions or recommendations are reached by consensus.
If it is not possible to reach a consensus, the scientific opinion or recommendation
can be adopted if supported by an absolute majority of the CHMP and co-opted
members2 or, in other words, support from 17 members (i.e., half of the 27 member
nations and five co-opted members) plus one additional member.
This book is designed to provide pharmaceutical companies with practical
insights and specific steps that will help regulatory teams succeed at these
high-stakes meetings.
“The Committee for Medicinal Products for Human Use (CHMP) is
arguably one of the most pivotal committees as it is the committee
that ultimately determines whether a medicine is safe, effective, and
of a high enough quality to be approved for use in humans.”
Serving Europe
The EMA was founded in 1995 and is responsible for assessing the efficacy,
safety, and quality of all medicines for Europe’s 500 million citizens. It serves 27 EU
member states plus Iceland, Liechtenstein, and Norway, which are in the European
Economic Area.1 Importantly, its decisions may also influence the UK’s Medicines
and Healthcare products Regulatory Agency (MHRA).
Within the EMA, there are seven scientific committees and several working groups
that evaluate the benefit-risk profiles of medicines for both humans and animals.
The Committee for Medicinal Products for Human Use (CHMP) and Committee
for Advanced Therapies (CAT) are arguably the most pivotal committees as these
committees ultimately determine whether a medicine is safe, effective, and of a
high enough quality to be approved for use in humans. The CHMP and CAT are
each made up of one member from each EU member state plus five co-opted
members who are chosen because of their specific scientific competence.
Once a company, also known as the applicant, has submitted its Marketing
Authorization Application (MAA) the CHMP carries out the initial assessment of
the application. During the process, the CHMP raises questions and may ask the
applicant to provide clarifications or additional analyses.
If the CHMP believes the benefits of a medicine outweigh the risks, it will
recommend to the European Commission that the applicant receive a marketing
authorization for its product.
The CHMP’s scientific opinions or recommendations are reached by consensus.
If it is not possible to reach a consensus, the scientific opinion or recommendation
can be adopted if supported by an absolute majority of the CHMP and co-opted
members2 or, in other words, support from 17 members (i.e., half of the 27 member
nations and five co-opted members) plus one additional member.
This book is designed to provide pharmaceutical companies with practical
insights and specific steps that will help regulatory teams succeed at these
high-stakes meetings.
“The Committee for Medicinal Products for Human Use (CHMP) is
arguably one of the most pivotal committees as it is the committee
that ultimately determines whether a medicine is safe, effective, and
of a high enough quality to be approved for use in humans.”