Regulatory Focus™ > News Articles > EMA Revamping How it Handles Submission of Applications and Requests for Advice

EMA Revamping How it Handles Submission of Applications and Requests for Advice

Posted 27 March 2014 | By Alexander Gaffney, RAC

The European Medicines Agency (EMA) has announced that it will soon change the way it handles changes to approved marketing authorizations (MAs) and other regular reports.

Background

As in the US, pharmaceutical companies are required to notify EMA of all changes made to their medications and manufacturing processes, as well as keep regulators informed about the safety of their products and any transfers of ownership.

Those changes fall into several categories, including:

  • Type IA variations, used to report changes in a company's quality system
  • Type IB variations, used to report minor changes unlikely to affect a product
  • Type II variations, used to report major variations capable of having a significant impact on the safety, quality or efficacy of a product
  • Periodic Safety Update Reports (PSURs), used to report adverse events on a regular basis
  • Administrative procedures such as transfers, 61(3) notifications (labeling changes) and corrigenda.

Change is Coming

In a statement, EMA said that going forward, companies will see a change in their points of contact at EMA to better reflect an ongoing structural reorganization at the agency. The new model will do away with the current "team lead" concept in favor of a more specialized regulatory oversight.

The team lead will be replaced by two new EMA functions, the agency explained:

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 (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.

At the time of a new regulatory application to the agency, EMA will assign a procedure manager to the application, who will then be the primary point of contact for applicants thereafter. "Nothing will change before the applicant has been notified," EMA added.

The Benefit

EMA said the new model would allow its regulatory staff to dispense more knowledgeable advice about products throughout their entire lifecycle, ensuring consistency.

While the concept is starting with variation reports, it will soon be rolled out to all applications and queries, EMA said.

In addition, EMA said it is launching a "dedicated service" on 1 April 2014 to answer questions and provide assistance to companies that are preparing submissions.


EMA Statement


Tags: EU

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