Respond to this discussion post in a positive way in 5-7 sentences As the USA has its FDA for regulating the drugs and o
Posted: Sun Apr 17, 2022 3:37 pm
Respond to this discussion post in a positive way in 5-7
sentences
As the USA has its FDA for regulating the drugs and other
medical products, Europe also has a regulatory agency known as the
European Medicine Agency (EMA) that guarantees the scientific
evaluation, supervision, and safety of medicines to protect human
and animal health for all the medical products that are being
marketed within the European Union (EU). The EMA has a dedicated
committee that looks after the safety of the medicines that are
being developed and marketed for human use, known as the
Pharmacovigilance Risk Assessment Committee (PRAC). Any issues that
have come across in any member state of the EU, the regulatory
action applies to all the states that come under the EU. PRAC came
into effect in 2012 to strengthen the safety monitoring of
medicines across Europe. They are responsible for detecting,
assessing, minimizing, and communicating the risk of adverse
events, while considering the therapeutic effect of the medicine.
EMA provides all the support by providing all data from clinical
practice available in electronic health records and prescription
databases. The PRAC provides recommendations on questions on
pharmacovigilance and risk management systems, including the
monitoring of their effectiveness to the Committee for Medical
Products for human use (CHMP) for centrally authorized medicines
and referral procedures. The regulatory agency has developed a
system known as the Eudravigilance for managing and analyzing the
information on suspected ADRs. This electronic reporting system is
obligatory for marketing authorization holders and sponsors
clinical trials. The PRAC evaluates safety signals from the
Eudravigilance and recommends regulatory actions. Eudravigilance
can help in facilitating the electronic exchange of individuals
case safety reports (ICSRs) between EMA, National Competent
Authorities (NCA), Marketing authorization holders (MAHs) and
sponsors of the clinical trial in the European Economic Area (EEA)
, also can help in providing better product information for
medicines authorized in EEA.
sentences
As the USA has its FDA for regulating the drugs and other
medical products, Europe also has a regulatory agency known as the
European Medicine Agency (EMA) that guarantees the scientific
evaluation, supervision, and safety of medicines to protect human
and animal health for all the medical products that are being
marketed within the European Union (EU). The EMA has a dedicated
committee that looks after the safety of the medicines that are
being developed and marketed for human use, known as the
Pharmacovigilance Risk Assessment Committee (PRAC). Any issues that
have come across in any member state of the EU, the regulatory
action applies to all the states that come under the EU. PRAC came
into effect in 2012 to strengthen the safety monitoring of
medicines across Europe. They are responsible for detecting,
assessing, minimizing, and communicating the risk of adverse
events, while considering the therapeutic effect of the medicine.
EMA provides all the support by providing all data from clinical
practice available in electronic health records and prescription
databases. The PRAC provides recommendations on questions on
pharmacovigilance and risk management systems, including the
monitoring of their effectiveness to the Committee for Medical
Products for human use (CHMP) for centrally authorized medicines
and referral procedures. The regulatory agency has developed a
system known as the Eudravigilance for managing and analyzing the
information on suspected ADRs. This electronic reporting system is
obligatory for marketing authorization holders and sponsors
clinical trials. The PRAC evaluates safety signals from the
Eudravigilance and recommends regulatory actions. Eudravigilance
can help in facilitating the electronic exchange of individuals
case safety reports (ICSRs) between EMA, National Competent
Authorities (NCA), Marketing authorization holders (MAHs) and
sponsors of the clinical trial in the European Economic Area (EEA)
, also can help in providing better product information for
medicines authorized in EEA.