The European Medicines Agency (EMEA) announced yesterday that it has begun a series of changes to its internal organisation, aimed at improving its functioning and how it delivers its core tasks to be introduced gradually by year-end.

The EMEA points out that its staff numbers and internal processes have grown in recent years, in line with its increased responsibilities. The number of scientific committees and the complexity of procedures have also increased, and the cross-relationship between committees brings a need for enhanced coordination. Moreover, the European Commission’s proposed “package” of pharmaceutical legislation will likely bring the Agency further responsibilities, it adds.

The reorganisation follows a process improvement exercise – whch specifically examined processes within the two human-use medicinal products units and monitored their interactions to assess their potential for adapting to future needs - and includes the following key changes:

- the life-cycle management of medicines for human use will be brought together into one Human Medicines Development and Evaluation Unit. It will be led by Patrick Le Courtois and have responsibility for the provision of advice during R&D, through to management of the review process and changes to products after they have been approved;

- a Patient Health Protection Unit will be established under the leadership of Noël Wathion. The new Unit will contribute to patient health protection from the perspectives of pharmacovigilance, risk and crisis management, patient and health care professional information, inspections (for both human and veterinary products) and appropriate regulatory compliance. It will also be in charge of Community procedures for both centrally and non-centrally authorised products;

- within the Unit for Veterinary Medicines and Product Data Management, led by David Mackay, one single Sector will be created, responsible for all areas of veterinary medicines and veterinary regulatory affairs, and another for the management of product data and documentation related to applications for the whole Agency. It will also be involved in the development of IT systems to support scientific business processes; and

- services within the Unit for Information and Communications Technology, led by Hans-Georg Wagner and within the Administration Unit, led by Andreas Pott, will be rationalised.

Implementation of the changes began early in September but for now, there will be minimal changes in staff responsible for product applications, in order to avoid disruption to the operation of upcoming scientific committee meetings, says the Agency. Applicants and marketing authorisation holders will be informed in due course of any changes to the teams or staff handling their applications, it adds.

Meantime, the EMEA’s public consultation on its proposed transparency policy has now concluded, and a second workshop on development of the policy will be held later this month, to analyse and review all comments and feedback received.

The new draft policy describes for the first time in one comprehensive document the Agency’s vision on its level of openness towards its stakeholders, and proposes to focus on three main objectives:

- making the EMEA’s daily operations more transparent: this will include a re-assessment of the currently-applied balance between transparency and protection of commercially- confidential information, and also lead to more proactive disclosure of information about the scientific evaluation of medicines. All of this will help to better explain how the Agency operates and how it reaches its scientific conclusions, it says;

- strengthening the Agency’s interaction with its stakeholders, particularly patients and healthcare professionals: the existing interaction will be further developed with a view to consulting patients and healthcare professionals on the scientific evaluation of medicines at the level of EMEA scientific committees;


- promoting a harmonised approach to transparency across the European medicines network: the Agency will work closely with the European Union (EU) member states’ medicines regulatory authorities to provide for a harmonised approach to transparency, including consistent implementation across the EU.

The draft transparency policy will be updated accordingly before its final adoption and publication, which is currently planned for year-end.