Module 6

04/10/2024

2. Risk Control (6) – Risk Reduction Ex 2

The Organisation for Professionals in Regulatory Affairs

Issues Management or Managed by Issues?

25

Current Risks in UK/Europe

1. Supply Chain Vulnerabilities : The European Economic and Social Committee (EESC) has highlighted the EU’s heavy reliance on imports of active pharmaceutical ingredients and finished medicines from Asia. 2. Critical Medicines List : The EMA and MHRA (DHSC) have identified a list of critical medicines for which supply continuity is crucial. 3. Strengthening Supply Chains : The EMA has published recommendations to address vulnerabilities in the production and delivery of these critical medicines. 4. Pharmaceutical Independence : To mitigate these risks, the EESC has proposed a Critical Medicines Act to secure Europe’s pharmaceutical independence and reduce reliance on external sources.

The Organisation for Professionals in Regulatory Affairs

26

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