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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.”
Continue Reading Update to the EMA’s Position on Access to Documents

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”.
Continue Reading Launch of the EMA’s Orphan Designation Portal

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.
Continue Reading Update on the EU Clinical Trials Portal and Database

The new EudraVigilance drug safety monitoring system has now been up and running for nearly 5 months, and the EMA has recently published an updated Q&A, featuring questions submitted by users, either through the service desk, or following the various technical and pharmacovigilance webinars run by the EMA.
Continue Reading New EudraVigilance System – Updated Q&As

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.
Continue Reading EMA’s revised approach to disclosure of the parties who request access to documents

In July, we reported that the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) had announced a joint proposal to promote the use of innovative approaches to paediatric drug development. We noted that the EMA expected to publish a Reflection Paper setting out a systematic approach to extrapolation of paediatric data by the end of the year. This has now been published.
Continue Reading EMA Reflection Paper on paediatric extrapolation

Legal clarity on the meaning of ‘commercially confidential information’ within sight

Demand for greater transparency and disclosure of pre-clinical and clinical data by industry continues to attract significant debate. Recent academic studies, published in Current Medical Research and Opinion and the British Medical Journal, have systematically assessed the disclosure policies of trial data arising from studies sponsored by pharmaceutical companies. In the EU, the European Medicines Agency (EMA) has adopted policies and guidance setting out its approach to data disclosure. Certain aspects of the adopted policies are currently being considered by European Courts, to address the nature of the balance to be struck between the public interest in transparency and the interest (both public and private) in protecting innovative research from unfair commercial use. In a broader context, the prevailing legal framework is based on a need for coherence and equilibrium between the general regulation governing public access or freedom of information and the sector-specific legislation regarding authorisation and supervision of medicines. In this blog post, we provide a summary of these cases, as heard in the European Courts to date.Continue Reading Update on transparency of clinical data

In advance of the launch of the new EudraVigilance System, on 22 November 2017, the EMA has published (on 5 July 2017) a 29 page Q&A, which is a summary of the broad ranging pre-launch questions submitted by stakeholders and the EMA’s answers. Answers have been kept succinct, with URL links to any further relevant guidance. The document is split into separate topics, including: Eudravigilance organisation and user registration;  Reporting to National Competent Authorities in the EEA; and Technical Questions, with an index and a useful glossary of terms at the beginning of the guide. The Q&A will be updated regularly. The EMA recommends that the Q&A be treated as a first reference point for queries, before users contact the Agency’s service desk.
Continue Reading EudraVigilance – What’s next?

On 20 July 2017, the EMA published the updated guideline on first-in-man (also known as phase I) clinical trials. First-in-man trials often carry the greatest risks, and have been the ones that generate the biggest headlines when they have gone wrong, for example the Phase I trial in France by Bial-Portela & CA SA in 2016. The new guideline, which applies not only to first-in-man trials, but also to all ‘early phase clinical trials’ that generate initial knowledge on tolerability, safety, pharmacokinetics and pharmacodynamics, aims to ensure such trials are conducted as safely as possible, and assists sponsors in the transition from non-clinical to early clinical development.
Continue Reading Updated first-in-man guideline

Under the new Clinical Trials Regulation 536/2014/EU, it is now a requirement for the sponsor of a clinical trial to report to the regulatory authorities a serious breach of the Regulation or to the clinical trial protocol (Article 52). A serious breach, in this context, is defined as “a breach likely to affect to a significant degree the safety and rights of a subject or the reliability and robustness of the data generated in the clinical trial“. This requirement is currently contained in the legislation of some Member States, such as in the UK (Regulation 29A Medicines for Human Use (Clinical Trials) Regulations 2004/1031), but was not previously included in Directive 2001/20/EC or in ICH GCP (although a sponsor should list all significant protocol non-compliances in the clinical study report). This is, therefore, the first time that there is such a requirement in all EU countries.
Continue Reading Consultation on serious breaches of clinical trial protocol