Starting from April 1, 2014, the European Medicines Agency (EMA) will begin revised operations for the following evaluation procedures for human medicines:
• Type IA and IB variations;
• Type II variations
• Periodic Safety Update Reports (PSURs);
• Administrative procedures such as transfers, 61(3) notifications and corrigenda.
The main change for applicants to these procedures will be a change in their EMA contact persons. Applicants will be informed directly by product and procedure if and when their contact person will change. Nothing will change before the applicant has been notified.
The changes will be implemented for new applications for the above-mentioned evaluation procedures submitted as of April 1, 2014. For ongoing applications, the agency has put in place a controlled transition plan, which foresees proactive and direct communication with applicants if and when changes occur.
The handling of all other evaluation procedures, including initial evaluation applications, will remain unchanged for the time being. Their roll-out is planned for later in the year.
The upcoming changes to the handling of evaluation procedures follow the structural reorganization of the agency from September 2013. They are the results of a period of analysis and consequent redesign of operating processes, introducing a new operating model for how medicines are managed through their entire lifecycle at the agency, focusing on scientific and procedure management.
The new operating model is designed to strengthen the support provided by EMA staff in terms of regulatory science and overall procedural management to its scientific committees throughout the lifecycle of a medicine. "This will support the committees in focusing on their core expertise, the scientific assessment of medicines, and delivery of high-quality opinions while it also ensures consistency and streamlining of handling of applications, leading ultimately to more efficient and consistent scientific assessment procedures," said EMA in a press release. This is also part of the EMA’s effort to streamline internal processes for increased efficiency so that increases in workload can be absorbed by the existing resources.
As part of this new operating model, the agency is revising the existing product team lead concept and replacing it with two new roles:
• A Procedure Manager to oversee all aspects of the management of specific procedures. Procedure Managers ensure regulatory consistency at the EMA and are responsible for managing the regulatory process surrounding each application. Procedure Managers provide guidance on regulatory procedural matters and serve as the primary contact point for applicants and experts from the national competent authorities in respect to their specific procedure.
• An EMA Product Lead or EPL to maintain oversight of a medicine as it moves through the different stages of its lifecycle. EPLs are responsible for the overall knowledge about a medicine and the wider context of a therapeutic area. They provide regulatory science input and facilitate discussions within and between the EMA’s scientific committees when needed.
A Procedure Manager will be appointed at the start of a new application procedure and will be the primary contact for applicants during the course of the evaluation. For queries that may come up before submission of an application, the EMA is establishing a dedicated service, which applicants can contact by email. This service will become operational from April 1, 2014 for all pre-submission queries related to the post-authorization procedures mentioned above and will be expanded in scope over time.
All procedural changes will be incorporated in the European Medicines Agency post-authorization procedural advice for users of the centralized procedure. Following the update, which will be made shortly, the post-authorization procedural advice will provide more detailed information for applicants, including on how to use the presubmission queries service for each of the evaluation procedures.
The new processes will be rolled out gradually, and the agency will continue to provide updates.
Source: European Medicines Agency