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.

Changes to Q&As

Not surprisingly, there have been some teething problems with the revised adverse drug reaction (ADR) reporting system, and the Q&A now runs to 122 pages.  The scope of the document has also been revised.  Some of the sections have been removed and will appear in the future as separate documents, e.g. signal detection and management (including Good Pharmacovigilance Practice (GVP) Module IX questions on signal management) and EudraVigilance Data Analysis System (EVDAS) issues.  The Go-Live Planning section has been removed entirely, since it is no longer relevant (but obviously still appears in previous versions of the document).  While new questions and answers have been added to most sections of the document, the most pressing concerns of stakeholders appear to centre on issues associated with the Individual Case Safety Report (ICSR) download manager, including detailed technical questions regarding its functionality, and more general enquiries relating to accessibility and compliance (Section 2).

Further guidance pending

While the EMA has not yet answered all of the questions posed, it has indicated (in the answer to Question 3.15, concerning the reporting requirements for serious ADRs found in medical literature publications) that it plans to issue “shortly” some clarification on the processing of ICSRs which marketing authorisation holders can download from the system.  Hopefully, this will help to allay marketing authorisation holders’ concerns regarding potential compliance issues in this area.

The dossier will continue to be updated as the system becomes more familiar to users, and glitches are ironed out.  According to the EMA, the Q&A should continue to be the first port of call for users to resolve their queries, prior to contacting the EMA’s service desk.

The General Data Protection Regulation (GDPR) (EU) 2016/679 comes into force on 25 May 2018. It is a substantial change to the EU’s data protection regime, and non-compliance may lead to heavy fines.  On the eve of implementation, Arnold & Porter’s Future Pharma Forum invites you to a roundtable discussion on how life will differ under the new legislation, and key issues that in-house lawyers should be aware of.

Topics

  • A refresher on the GDPR, what it covers and how it applies to life sciences companies
  • An overview of latest guidance and developments in the run up to implementation
  • Discussion of current hot topics / open questions for the life sciences sector

See the website for more information, or sign us here. Hope to see you there!

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

On 11 December 2017, we reported that Advocate General Bobek had opined in Case C-557/16, Astellas Pharma GmbH, that Concerned Member States (CMS) are co-responsible for marketing authorisations granted under the decentralised procedure (DCP).

This morning, the Court of Justice of the European Union (CJEU) handed down its judgment in the case. The Court ruled that:

  • Article 28 and Article 29(1) of Directive 2001/83/EC (the Directive) must be interpreted as meaning that, in the framework of a DCP for the placing on the market of a generic medicinal product, the competent authority of a CMS cannot itself determine the starting point of the regulatory data protection (RDP) period of the reference medicinal product after the close of the coordinated procedure, and when it adopts its decision on the generic medicinal product in that Member State. However, the CMS is part of the assessment procedure, and must verify the expiry of the RDP period (para 29), or not approve the assessment report (para 30).
  • Article 10 of the Directive, read in conjunction with Article 47 of the Charter of Fundamental Rights of the European Union, must be interpreted as meaning that a court of a CMS involved in a DCP, when faced with an action brought by the holder of the marketing authorisation of the reference medicinal product, against the generic marketing authorisation granted in that Member State, is competent to review the determination of the starting point of the RDP period of the reference medicinal product. On the other hand, that court does not have jurisdiction to determine whether the initial marketing authorisation for the reference medicinal product granted in another Member State was granted in accordance with the Directive.

We will post our analysis of the judgment soon.

In February 2018, the Integrated Research Application System (IRAS) issued revised versions of the template model Clinical Trial Agreement (mCTA) and Clinical Research Organisation model Clinical Trial Agreement (CRO-mCTA, used where clinical research organisations undertake site management responsibilities on behalf of the sponsor). The new mCTAs are designed to be used without modification for industry-sponsored trials in the national health service (NHS), and have been updated to reflect current practice and regulations. The new mCTAs should be used from 1 March 2018.

Continue Reading Revised model Clinical Trial Agreements applicable across the UK

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.

Continue Reading EMA issues report on animals used in testing of medicines

Article 118a of Directive 2001/83/EC requires Member States to lay down “effective, proportionate and dissuasive” penalties for those who are involved in the manufacturing, distribution, brokering, import and export of falsified medicinal products. On 26 January 2018, the European Commission published a report on how this requirement has been met by individual Member States, based on a detailed study performed by external contractors, empirica and  ZEIS, on behalf of the DG for Health and Food Safety.

The report indicated that 26 Member States had amended their legislation to accommodate new penalties for the falsification of medicinal products. The exceptions were Hungary, which changed its Criminal Code as a result of the Council of Europe Medicrime Convention, and Finland, which already had penalties in place before Article 118a took effect.

In 21 Member States, the manufacturing, distribution, brokering, import and export of falsified medicinal products attracts criminal penalties. In the remaining Member States (Bulgaria, Finland, Latvia, Romania, Poland, Sweden and Lithuania) only certain infringements are considered criminal.

Continue Reading Commission Survey on National Penalties for Breach of Falsified Medicines Rules in EU Member States

Software can be considered a medical device under EU law. Although guidance has been issued by the European Commission and national authorities to assist in legal classification, factors or criteria that are considered as relevant in such guidance have not been validated by European or national courts. The recent decision of the Court of Justice of the European Union (CJEU) on legal classification of software medical device is therefore instructive.

The European Court’s first decision on the classification of software in the context of medical devices legislation

On 7 December 2017, the CJEU issued its judgment in Case C-329/16. The CJEU agreed with the Advocate General’s opinion (discussed in our previous advisory), and held that software can be classified as a medical device under EU law if the software has at least one functionality that allows the use of patient-specific data to assist the physician in prescribing or calculating the dosage for treating the underlying condition. It does not matter whether the software acts directly or indirectly on the human body. The decisive factor is whether the software is specifically intended by the manufacturer to be used for one or more medical objectives specified in Article 1(2) of Directive 93/42/EEC (the Medical Devices Directive), including the diagnosis, prevention, monitoring, treatment or alleviation of disease.

Continue Reading Classification of software as a medical device

Join us for a complimentary medical devices bootcamp aimed at junior lawyers and new joiners in the medical devices and life sciences sectors

During this full-day seminar we will provide a comprehensive introduction to the regulation of medical devices  including changes introduced by the new medical devices and in vitro diagnostic Regulations, and what this means for your organisation. We will also be joined by guest speaker Graeme Tunbridge from the MHRA who will talk the audience through the role of the Regulatory Authority.

Topics include:

  • Definition and life cycle of a medical device
  • Introduction to the relevant legislation- including changes under the MDR/IVDR
  • Classification of a medical device
  • Conformity assessment procedure
  • Clinical investigations
  • Post-authorisation obligations
  • Promotion and market access
  • Companion diagnostics
  • Liability issues

The full agenda and link to RSVP can be found on the website. Hope to see you there!

At the end of December, a new version of Chapter 1 of Volume 2A of the Notice to Applicants was published by the Commission. The Notice to Applicants is prepared by the European Commission, in consultation with the competent authorities of the Member States and the EMA, and sets out guidance on the interpretation of the EU legislation. The recent update does not introduce wholesale changes, but there are a few interesting additions:

Continue Reading New NTA published