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In April, the network of Heads of Medicines Agencies in the EU (HMA) launched a public consultation on common regulatory approaches for allergen products. The consultation puts several draft recommendations to the attention of interested parties.

HMA summarises the various types of market authorisation (MA) regimes currently in place in the EU, as well as the involved shortcomings. The document, thus, makes the case for greater harmonisation among different regulatory approaches.

EFA welcomes initiative in light of increasing allergy prevalence

EFA welcomes the initiative, in light of the increasing prevalence of allergies – including rare allergies. In particular, we perceive the harmonization of MAs among EU Member States as bearing multiple benefits. These include:

  • Reducing discrepancies in the quality, efficacy and effectiveness of marketed medicines, and indeed improving access, coordination and information in case of shortages. By implication, a more stable MA framework constitutes an important step towards addressing medicine shortages. Both the quality and availability of medicines are important for patients with chronic conditions such as food allergies, typically linked with long-term treatment requirements.
  • Enabling the process of developing allergen products for common allergies, and for non-prevalent allergies in particular.

EFA response to HMA public consultation considers response to EMA

The HMA consultation has several links with the European Medicines Agency consultation on allergen product development in low-sized populations. Responding to HMA, at EFA we focused among many others on the following points:

  • When reflecting on current requirements, it would also be interesting to mention that some current diagnostic tests are unreliable, further restricting the available options for patients.
  • In addition to a highly needed guidance for non-prevalent allergies, HMA should also look into the existing MA regulations for new or recently emerged allergies.
  • It would be advisable that HMA explicitly cite the different sub-types of allergy associated with the allergen product classes under the scope of these recommendations (possibly in an Annex). In this respect, it would be particularly important to highlight the differences, if any, among Member States as to what constitutes rare allergies.
  • Patients should be consulted in the context of the well-established use application process, especially in the discussions on medicines intended for the treatment of rare or severe allergies.
  • EFA agrees with HMA that the Mutual Recognition Procedures (MRP) and the Decentralised Procedures (DCP) should be strengthened and better coordinated.

The full EFA response to the HMA public consultation on common regulatory approaches for allergen products is available here.