Registration and access

The Consortium, in case of a successful outcome of the clinical program, aims to obtain a positive opinion (Article 58) from the EMA in 2022, followed by WHO prequalification and local approval of Levo-regulatory Praziquantel 150mg in the first African priority countries through the collaborative procedure pathway. Apart from EMA, the Marketing Authorization Application shall be submitted in Brazil.

In collaboration with WHO and external experts, the Consortium has prepared an Access & Delivery plan, that will ensure timely registration, accessibility and affordability of the pediatric praziquantel treatment.

Registration

If the outcome of the clinical program is positive and no obstacles that might cause delay occur, submission of the registration dossier (article 58 procedure) to EMA of the new praziquantel product is scheduled in 2021. Since its inception in 2012, the Consortium has been in close contact with various regulatory authorities, including endemic countries, to discuss the most optimal clinical trial program and registration route per the relevant local legislation.

Access and affordability

Once approved, the product will be made available on a not-for-profit basis. Together with relevant stakeholders, the Consortium is exploring new procurement and business models, including local manufacturing, to ensure that the product is available free of charge to the young patients in need. As part of its overall Access strategy, the Consortium is planning a pilot and implementation program in the first African priority countries.