In the dynamic landscape of pharmaceuticals, obtaining a centralised marketing authorisation in the European Union (EU) is a crucial step for companies looking to bring their medicines to a broad market. The European Medicines Agency (EMA) is responsible for the scientific evaluation of applications for centralised marketing authorizations in the EU, offering a streamlined process that enables companies to submit a single marketing authorisation application (MAA) and to market their products across the entire European Economic Area (EEA), which includes the EU countries, Iceland, Norway and Liechtenstein, based on a single authorisation.

Successfully navigating the centralized MAA process requires meticulous planning, proactive engagement and collaboration with EMA, and adherence to deadlines. The planning journey begins with the submission of an eligibility request to confirm eligibility for evaluation under the centralised procedure, using a specific form accompanied by justification of eligibility criterion fulfilment via EMA online portal. This step is required regardless of whether the product falls into the mandatory or optional scope of the centralised procedure. The eligibility request should be submitted 18 to 7 months before the planned MAA submission date and submitted to EMA 10 calendar days before the planned and published CHMP meeting date. Decision of eligibility is received in the week following CHMP meeting where the discussion took place.

After confirmation of eligibility, a notification of intention to submit an application is crucial, providing the intended date of MAA submission in alignment with published submission dates. Equally crucial is requesting the appointment of the Rapporteurs and Co-Rapporteurs for the scientific assessment in a timely manner. Companies are advised to submit the letter of intent and the request for (Co-)Rapporteurs assignment at least 7 months prior to the intended MAA submission date. EMA will then follow an internal process to appoint the (Co-)Rapporteurs from among the members of the Committee for Medicinal Products for Human Use (CHMP) or the Committee for Advanced Therapies (CAT), depending on the type of product, and among the Pharmacovigilance Risk Assessment Committee (PRAC) members. If the eligibility request had not been submitted before, it can be submitted with the letter of intent, being the (Co-)Rapporteurs automatically appointed after the confirmation of eligibility provided that the MAA submission is planned within 6 to 7 months.

The intended MAA submission date communicated to EMA will need to be re-confirmed 2 to 3 months before the target date by e-mail to ensure adherence to deadlines and appropriate allocation of EMA resources and expertise. The submission date should be realistic and only proposed when the company envisages that the MAA dossier will be complete and sufficiently mature at that date.

Companies are not alone in this journey. MAA pre-submission interactions with EMA are recommended to start about 6 to 7 months before the intended submission date. These interactions provide a valuable opportunity for applicants to seek product-specific procedural and regulatory advice, ensuring a smoother application process and subsequent assessment of the application. Not all pre-submission interactions may require a dedicated meeting, but the applicant may request one if further clarification is needed on the written responses received. EMA may also propose a meeting in complex cases. It is also recommended to meet the appointed (Co-)Rapporteurs at the national level. If a meeting is identified as necessary, EMA may also propose a joint meeting between the applicant, relevant EMA experts and the (Co-)Rapporteurs.

Last but not least, the MAA submission phase involves using the electronic common technical document (eCTD) format and submitting the application through the eSubmission gateway or web client. Therefore, applicants should become familiar with the technical requirements and set up the necessary access to the electronic submission channels well in advance to the MAA submission date. Additionally, consultation with regulatory experts, such as Rho, may be essential to support you in completing a successful MAA submission.

If you are planning for a centralised MAA in the EU, our Rho experts can accompany you through this exciting journey from both the strategic and operational aspects. There are important considerations to keep in mind while preparing the MAA dossier that will be the subject of future blog posts.

Ugnė Venckytė, MSc., Regulatory Affairs Assistant, is a skilled professional with expertise in regulatory compliance and clinical trial management. With a background as a Regulatory Affairs Manager and Team Leader, she has led marketing authorization efforts, managed submissions and conducted crucial regulatory reviews. Holding a master’s degree in Medicinal Chemistry, Ugnė combines academic knowledge with practical experience, highlighting effective coordination, adaptability and a commitment to excellence. Her diverse skill set and dedication make her a valuable asset in advancing regulatory affairs and clinical trials.