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ICMRA Crisis Management ProjectUpdate
Dr Jarbas Barbosa
Director-President of ANVISA
Summit of Heads of Medicines Regulatory Agencies Symposium – 27 October 2017
ICMRA Crisis Management Project
ICMRA Mapping Project
Conclusion: gap on international mechanisms for regulators on crisis management =
opportunity for ICMRA to discuss regulators role in global health crisis
Crisis Management Project
Led by Brazil
DocumentationFramework + SOP
Framework for the involvement of Health Regulatory Authorities in the management of global health crisis +
Standard Operational Procedures
Framework for the involvement of Health Regulatory Authority in the management of Global Health Crisis:
• Global health crisis from health regulator’s perspective• Involvement of regulators envisaged at 3 levels
• Level 1 - Incidents of quality or safety issues for products with global impact on public health
• Level 2 - Unavailability of products due to a crisis• Level 3 - Urgent need for new medical treatments or vaccines in the face of an
emerging health treats• Focus levels 2 and 3 with description of roles and responsibilities for regulators• Communication as a key part
ICMRA Crisis Management Project
Standard Operating Procedure for Facilitating Prompt Collaboration among Heads of Regulatory Authorities
• Annex to the Framework• Definition of ICMRA 24/7 emergency contact list and means for communication• Model Alert Notification• Template Agenda for Emergency Calls
ICMRA Crisis Management Project
ICMRA Crisis Management Project
Side eventWHA 70
“The Role of Regulators in Global Health Emergencies”
Crisis Management Workshop
The Role of Regulators in Global Health Emergencies
ICMRA Crisis Management Project
Side eventWHA 70
“The Role of Regulators in Global Health Emergencies”
Crisis Management Workshop
Reach a common ground on what are the expected results of this
partnership established between ICMRA and WHO on crisis
management
ICMRA Crisis Management Project
Conclusions reached to date: considerations about regulators’ role in emergency situations (1)
• WHO is the international leader in public health emergencies of international concern (PHEIC), and regulators must collaborate with the Organization in a coordinnated manner
• ICMRA shall act as coordinator of regulators and engage with WHO during a PHEIC
• Regulators need to have an implemented plan for health emergency situations
ICMRA Crisis Management Project
Conclusions reached to date: considerations about regulators’ role in emergency situations (2)
• Regulators must take fast action in situations of crisis• Collaboration and regulatory reliance is paramount to fast
action of individual regulators• Regulators should consider implementing facilitated
regulatory pathways for marketing approval of drugs already approved by other regulator
Next Steps:
• Brazil will update the document “Framework for the involvement of Health Regulatory Authorities in the management of Global Health Crisis” taking into consideration workshop discussions
• Updated document will be circulated to group members for comments• Teleconference to finalize the document• Presentation of final document for approval in the first ICMRA meeting of 2018
ICMRA Crisis Management Project