Shortages of medicinal products due to manufacturing and quality - PowerPoint PPT Presentation

Shortages of medicinal products due to manufacturing and quality problems – update from working groups Joint PCWP-HCPWP meeting 25 February 2014 Presented by: Andrea Taft, PhD, Scientific Administrator, Scientific & Regulatory Management Department An agency of the European Union

Overview • Background & experience • Reflection paper & Implementation Plan • Results • Further steps 1 Joint PCWP-HCPWP meeting 25 Feb 2014

Reflection paper on medicinal product supply shortages caused by manufacturing/ good manufacturing practice compliance problems & Implementation plan 2012 - 2015 • Develop common understanding of “critical” medicine • Develop decision tree for escalation of a shortage to EU level • Clarify national input into EU advice • Improve communication on supply shortages • Raise industry awareness and improvements • Improve international co-operation and sharing of information 2 Joint PCWP-HCPWP meeting 25 Feb 2014

Working groups 1. CHMP sub-group on shortages due to manufacturing and quality problems • Focused on action items for the Agency response – CAPs 2. HMA virtual working group on shortages due to manufacturing and quality problems • Focused on action items for the Network response - NCAs 3 Joint PCWP-HCPWP meeting 25 Feb 2014

CHMP working group • Appointed in Sept 2012 • Agreed outputs – Guidance on communications – Definition of criteria for “critical” medicinal product – Template for CHMP assessment – Criteria for considerations during assessment & triggers for proactive risk management – National and EU rules for escalation and communication 4 Joint PCWP-HCPWP meeting 25 Feb 2014

Outcomes and results Action/Focus group CHMP sub-group HMA virtual group CHMP adoption Definition of a "Critical medicinal product" yes yes Aug-13 "Decission tree" for an escalation of a supply shortage yes yes Aug-13 Points to consider for assessment of shortages yes Aug-13 Risk indicators of supply shortages yes Aug-13 Resources for issuing treatment recommendations yes Aug-13 Closing report for assessment of a shortage yes Dec-13 Communication plan on drug shortages yes yes Aug-13 Public catalogue of supply shortages yes N/A 5 Joint PCWP-HCPWP meeting 25 Feb 2014

What can industry do? • Shift focus from reactive to proactive risk management and more explicitly assess supply chains and transport risks as part of procurement and contract management and corporate governance processes. • Improve pre- and post-incident communication on disruptions. • Industry associations : develop and share methodologies for assessment, information sharing, communication. • Marketing authorisation holders : develop supply chain resilience. 6 Joint PCWP-HCPWP meeting 25 Feb 2014

Workshop Held in London, 14 th October 2013. • • Attended by Competent Authorities, HCPs, Patient representatives, Industry Associations; • Broadcast live; • Presentations; report will be available on EMA webpage • Recording will be available on YOUTUBE shortly 7 Joint PCWP-HCPWP meeting 25 Feb 2014

Industry project ISPE and PDA will: • deliver to the EMA a proposal and plan that addresses the prevention of drug shortages due to manufacturing quality issue. EFPIA and EGA will • develop a complementary project on communications. Consultation with Patients’ and Physicians’ representatives 8 Joint PCWP-HCPWP meeting 25 Feb 2014

Further steps • Review of effectiveness of processes • Follow up meetings with industry associations • International cooperation 9 Joint PCWP-HCPWP meeting 25 Feb 2014

Thank you for your attention 10 Joint PCWP-HCPWP meeting 25 Feb 2014