Regulatory information – A new operating model for procedure management to improve support for evaluation procedures

Change will optimise support on regulatory procedural aspects

The Agency is introducing a new operating model for the management of evaluation procedures for human medicines¹. With the new model procedure managers and procedure assistants will be allocated per product, rather than per procedure, in order to improve the co-ordination of regulatory activities with a product, particularly where multiple regulatory procedures are run in parallel for the same product. The strong procedural focus that has already been achieved with the current model will be maintained and strengthened through the creation of process-focused communities that comprise EMA staff specialising in specific procedures.

From 1 June all type II variations, extension applications, periodic safety update reports (PSURs), renewals and post-authorisation measures (PAMs) along the lifecycle of a centrally authorised medicine will be handled by a single procedure manager at the European Medicines Agency (EMA). Regulatory procedures that have started before that date will be finalised by the originally appointed procedure manager, before the medicine is transferred to the single procedure manager.

The Agency will notify all marketing authorisation holders directly of the names of the procedure manager and the procedure assistant who together will serve as the single EMA contact point for their medicine.

This change is made to allow the Agency to better cope with fluctuations in volumes of submissions for different procedures. It takes into account the experience gained since a reorganisation of the Agency's structure and processes introduced two new roles:

• A Procedure Manager to oversee all aspects of the management of regulatory procedures and ensure regulatory consistency at EMA.
• An EMA Product Lead (EPL) to build up the overall knowledge about a medicine and its therapeutic area as it moves through the different stages of its lifecycle and facilitate discussions within and between EMA's scientific committees when needed.

These roles remain unchanged. Similarly, no changes will be made to the already appointed EPLs in charge of the scientific oversight of the medicine.

Pre-submission query service mailboxes for type II variations, extension applications, PSURs, renewals and PAMs, to which applicants are currently sending their queries, will cease to function by the beginning of July, when the transition is expected to be completed. Companies can send queries relating to any of these procedures directly to the procedure manager for their medicine.

Note

¹ It was added on 2 June 2016 that the new operation model only applies to the evaluation procedures for human medicines.