Shortages and Crisis Preparedness: EMA Publishes List of the Main Therapeutic Groups of Medicinal Products

Recommendation

20 June 2023
Barcelona, Spain

GMP & GDP Forum 2023
Day 1 only

On 8 July 2022 the EMA published the List of the Main Therapeutic Groups of Medicinal Products that are used for emergency care, surgeries and intensive care. This list was established by the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG). It will be used to help setting up the following further lists:

• the major event critical medicines list (MECM),
• the public health emergency critical medicines list (PHECM).

The list of the main therapeutic groups which is based on the WHO ATC classification, consisting of five levels, indicates the therapeutic subgroups (level 2) and the relevant pharmacological subgroups (level 2).

The legal basis for these lists as well as for the existence of the steering group is Regulation (EU) 2022/123 of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices.

Background

Regulation (EU) 2022/123 assigns increased responsibility to the EMA in order to guarantee the smooth functioning of the internal market as regards medicinal products and medical devices in critical situations. EMA's extended mandate includes mainly the monitoring of the supply situation of medicinal products and medical devices in the case of public health emergencies. You can find further information on EMA's strengthened mandate under EU: Strengthening the EMA.

Methodology for the establishment of lists of the main therapeutic groups and of the lists of critical medicines

The methodology for the establishment of lists of the main therapeutic groups and of the lists of critical medicines is described in the EMA document Methodology for the establishment of lists of "main therapeutic groups" in crisis preparedness and of the lists of "critical medicines" in the context of a major event and/or public health emergency dated 11 May 2022.

The establishment and maintaining of the list of the main therapeutic groups is carried out in four steps:

• The EMA secretariat coordinates the compilation of information for the list as well as its development and consults to this end the working groups of different organisations and associations (such as Patients and Consumer Working Party, PCWP; Healthcare Professionals Working Party, HCPWP etc.).
• The steering group (MSSG) adopts the list. 
• The EMA publishes the list on its website. 
• The list is reviewed on a yearly basis and updated, whenever necessary.

A similar methodology is envisaged for the establishment and maintaining of the lists of critical medicines:

• The EMA secretariat coordinates the preparation of the draft lists and consults the central contacts of the Medicines Shortages single point of contact working party as concerns the identification of critical medicinal products.
• Stakeholders of the pharmaceutical industry are consulted to review the lists. The steering group is tasked to continuously review the lists. 
• The steering group adopts the lists.
• The EMA publishes the lists on its website. 
• The lists are reviewed by the EMA in close collaboration with the steering group and other stakeholders of the pharmaceutical industry.
• The lists are updated, whenever necessary.

In order to facilitate the monitoring of shortages of medicinal products on the lists of critical medicines, the EMA may request the relevant marketing authorisation holders to submit all required information. Moreover, marketing authorisation holders were asked to designate their single points of contact by 2 September 2022. These and further obligations on marketing authorisation holders are regulated in Article 10 of Regulation (EU) 2022/123.