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

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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

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Overview

• Background & experience
• Reflection paper & Implementation Plan
• Results
• Further steps

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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

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

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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

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Outcomes and results

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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

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What can industry do?

• Shift focus from reactive to proactive risk management and

more explicitly assess supply chains and transport risks as part

• f 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.

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Workshop

• Held in London, 14th 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

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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

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Further steps

• Review of effectiveness of processes
• Follow up meetings with industry associations
• International cooperation

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Thank you for your attention