Drug Shortages Global Regulatory Working Group

The European Medicines Agency (EMA) is a member of the Drug Shortages Global Regulatory Working Group (DSGR WG). This international working group fosters collaboration to prevent, mitigate and monitor medicine shortages with a global impact.

The Drug Shortages Global Regulatory Working Group aims to strengthen international collaboration in preventing and responding to medicine shortages with a global impact. 

It does so through the following activities:

• Enhancing transparency and communication among regulatory authorities
• Identifying opportunities for international alignment and coordination of actions taken to prevent and mitigate medicines’ shortages where appropriate
• Discussing policy measures and best practices to address shortages

The working group is composed of medicine regulators. The World Health Organization (WHO) participates as an observer.

The roles of chairing and vice-chairing rotate among the members of the working group. 

The working group meets on a quarterly basis with the option of having ad hoc meetings.

For more information on how EMA helps tackle medicine shortages, see:

• Medicine shortages and availability issues

Composition

The following medicine regulatory authorities join EMA in this working group:

• Therapeutic Goods Administration (TGA) of the Australian Government Department of Health, Disability and Ageing
• Health Canada
• Japanese Ministry of Health, Labour and Welfare (MHLW)
• United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) and Department of Health and Social Care (DHSC)
• United States Food and Drug Administration (FDA)

WHO participates in the working group as an observer.

Activities to address shortages

Its collaborative efforts helped manage global medicine shortages during the COVID-19 pandemic. This included the simultaneous surge of COVID-19, influenza, and respiratory syncytial virus (RSV), also known as 'tripledemic', during the autumn and winter of 2022-23.

Subgroups

In 2024, the working group established a subgroup to address shortages of GLP-1 receptor agonists.

The working group may create other subgroups to facilitate in-depth discussions on priority topics as deemed necessary.