10 raccomandazioni da EMA per fronteggiare la carenza di farmaci
The draft guide has been presented during the meeting on the HMA/EMA Task Force on Availability of Authorised Medicines with Industry Associations held on 12 September 2022. Medicine shortages are recognised as a global problem by the European Medicines Regulatory Network (EMRN) and other international organisations such as the World Health Organization.
The guide recommends good practices on shortage prevention to the key stakeholders – including HCPs and patient support groups - involved in the medicines supply chain to reduce the likelihood of shortages occurring in the first instance.
Ten recommendations are being consulted upon, which the ERMN believes can form the foundation for implementing preventative strategies.
The guide is the culmination of several EU initiatives:
- European Commission’s Pharmaceutical Strategy
- Joint task force of the Heads of Medicine Agency and European Medicines Agency (EMA) on the availability of authorised medicines for human and veterinary use
- Development of the European Single Point of Contact (SPOC) network, which has facilitated greater communication on shortages that may impact multiple countries
- Legislation to expand the remit of the EMA to enhance coordination of shortages from an EU perspective
- European Joint Action on shortages, and
- Inclusion of medicine shortages in the European Medicines Agencies Network Strategy to 2025.
Stakeholders have been contacted for the opportunity to submit comments to shape the external regulatory environment. The EMA’s deadline for receipt of comment is 18 November 2022.