On 3 June 2019, the European Medicines Agency (EMA) launched a public consultation on a draft guideline providing guidance on the quality dossier requirements for Drug-Device Combinations (DDCs) in the context of a marketing authorisation or post-authorisation application.

DDCs are human medicines that include a medical device. The guideline covers those devices that are necessary for the administration, dosing or use of the medicine. They can be integral, co-packaged or referred to in the product information of the medicine but supplied and obtained separately.


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Earlier this week, the Commission published a new Regulation amending Regulation 726/2004 that governs the centralised procedure and that sets out the rules for the EMA: Regulation 2019/5. Many of the changes move and consolidate the provisions set out in other Regulations into Regulation 726/2004 on the centralised procedure (known as the Regulation on the Centralised Procedure). We are preparing a more detailed advisory of the implications of the new Regulation, but some headline points are as follows:

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In a report published on 16 July regarding the implementation of its flagship policy on the publication of clinical data (Policy 0070), the EMA has announced that Brexit and the Agency’s relocation will result in some areas of work being “temporarily reprioritised, suspended or postponed to resource Brexit preparedness activities and safeguard

On 27 June 2018, the EMA published a short notification on its website informing readers that “The Agency is no longer in a position to process access to documents requests issued from outside the EU.

Article 2(2) of Regulation (EC) No 1049/2001, setting out the EU legislative framework for freedom of information (the Public Access Regulation), provides EU institutions with the discretion to disclose to individuals from third countries documents they have drawn-up or received, provided the conditions of such access are no less restrictive than that provided to EU citizens under Article 2(1) of the same regulation. This change in policy means that only “Citizens of the EU and natural or legal persons residing or having their registered office in an EU Member State have the right of access to EMA documents.
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Yesterday, the EMA launched a new secure online portal called IRIS for the submission of applications for orphan designation and the management of post-designation activities. The aim is for the portal to be used for all activities relating to orphan designation, including applying for orphan designation, requesting pre-submission meetings, responding to requests for supplementary information and transferring orphan designation to a new sponsor. The hope is that this will provide a “comprehensive procedural and scientific support system for orphan designations”, and IRIS is being treated as a “pilot for [a] future Agency-wide platform for procedure management”.
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While the Clinical Trials Regulation (EU No. 536/2014) (the Regulation) was adopted in April 2014, the Regulation does not come into operation until 6 months after the clinical trials portal and database (the EUPD) has been set up, independently audited, and notification of the successful audit published by the Commission. The operation of this database has been delayed a number of times, as the development of a system to cover so many aspects of the new Regulation is taking longer than expected.

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The European Ombudsman, who investigates complaints of maladministration in the institutions and bodies of the European Union, recently handed down its decision in a case against the European Medicines Agency (EMA). The complaint concerned the EMA’s refusal to disclose the identity of parties who request access to documents held by the EMA. In the past, the EMA had stated that the “identity and/or the name of the organisation of the requestor will be used for the sole purpose of processing the request and will not be disclosed to third parties”. Instead, third parties, including the owner of the document requested, would only be told the request came from a “pharmaceutical company” or “law firm”. Last week, the Ombudsmen confirmed that the EMA has changed its policy in light of its recommendations.

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The principle of Replacement, Reduction and Refinement of animal testing in the development of medicines (known as the 3Rs) refers to the replacement of animal studies with non-animal methods, the reduction of animal studies, and the refinement of any necessary tests through minimisation of stress of study animals (as illustrated in the graphic below). Under European law, all EU Member States must ensure that the 3Rs are systematically considered whenever animals are used for scientific purposes, including research, regulatory testing and production, education and training (see Directive 2010/63/EC on the protection of animals used for scientific purposes). On 26 February 2018, the European Medicines Agency (EMA) issued a Report summarising its activities during 2016 and 2017 in relation to the 3Rs in the regulatory testing of medicinal products.

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