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strategies to streamline current practice. The group also discussed internal Signal Management process
improvement in the framework of the EMA reorganisation.
12.4.1.2. Update of the Signal Management worksharing list
The EMA Secretariat presented to the PRAC a draft updated list of active substances / medicinal
products subject to work-sharing for signal management. Following consultation of Member States in
recent months, new substances have been allocated to a Lead Member State while a number of
previously allocated substances no longer have a Lead Member State. These changes have been
reflected in the draft updated list. The list will be communicated to the CMDh for endorsement prior to
publication on the EMA website.
Post-meeting note: A preliminary discussion on the draft updated list took place at the March CMDh
meeting. Follow-up discussion is planned at the April meeting prior to formal endorsement of the list.
12.5. Adverse Drug Reactions reporting and additional reporting
12.5.1. Management and Reporting of Adverse Reactions to Medicinal Products
12.5.1. Individual Case Safety Report (ICSR) standard
Draft EU ICSR Implementation Guide
The EMA secretariat presented the EU ICSR implementation guide created in consultation with the
EudraVigilance Expert Working group. The draft document is scheduled to go out for a 2-month public
consultation starting at the end of April 2014. PRAC members were invited to send their comments in
writing by 28 March 2014. An update is planned at the April 2014 PRAC meeting.
12.5.2. Additional Monitoring
None
12.5.3. List of Product under Additional Monitoring
12.5.3.1. Consultation on the draft List, version March 2014
The PRAC was informed of the products newly added to the additional monitoring list and the updated
list.
Post-meeting note: The updated additional monitoring list was published on 26/03/2014 on the EMA
website (see: Home>Human Regulatory>Human medicines>Pharmacovigilance>Signal
management>List of medicines under additional monitoring).
12.6. EudraVigilance Database
None
12.7. Risk Management Plans and Effectiveness of risk Minimisations
None
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/253432/2014 Page 40/64