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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Arnold & Porter’s Future Pharma Forum invites you to a complimentary regulatory seminar aimed at junior lawyers and new joiners in the UK/EU life sciences industry. We will provide a comprehensive introduction to key EU regulatory law topics from an in-house practitioner’s perspective and touch on the implications of Brexit.

Topics

  • Overview of the EU

The next Future Pharma Forum will be on 27 September: Implications of Recent EU and UK Court Decisions in the Pharmaceutical Sector

Emily MacKenzie, Barrister at Brick Court Chambers, will join us to recap on how challenges to pharmaceutical decisions may be brought to the European and domestic courts. Emily will provide a summary

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

Yesterday, the UK Government finally published its White Paper setting out its position on the UK’s continued relationship with the EU post-Brexit. Theresa May has said it “delivers on the Brexit people voted for”, although others in Parliament disagree. While at a very early stage of the negotiations, and with no real indication of how the European Commission has received the White Paper, other than that it represents important progress for focusing the further discussions, we set out below the key points for the supply and manufacture of medicinal products and medical devices after Brexit.


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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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