Clinical Trials

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The EMA and the competent authorities of the EU Member States have issued guidance to manage the conduct of clinical trials and the supply of medicinal products during the COVID-19 pandemic. This Guidance is particularly important for all sponsors conducting studies in the EU and for pharmaceutical companies supplying medicines in the EU. We discuss…

The UK government published its Medicines and Medical Devices Bill (the Bill) on 13 February 2020. The Bill seeks to introduce delegated powers which will allow the Secretary of State to amend or supplement the existing UK regulatory framework for medicines, medical devices, clinical trials and veterinary medicines at the end of the transition period for the UK’s departure from the EU (the Transition Period), which is currently scheduled for 31 December 2020. The Bill also consolidates and expands on the existing UK medical devices enforcement powers and provides for an information gateway to permit sharing of information held by the Secretary of State in relation to medical devices.
Continue Reading UK government publishes new draft legislation on medicines and medical devices

On 16 October 2019, the European Commission published the Guidelines for Good Clinical Practice (GCP) specific to advanced therapy medicinal products (ATMPS) covering gene therapies, cell therapies and tissue engineered products. These Guidelines are available at the website of the European Commission.

Background

The European Commission was legally required to adopt the GCP Guidelines specific to ATMPs (the Guidelines) by Regulation (EC) No 1394/2007 (ATMP Regulation) with the technical input from the European Medicines Agency (EMA). The Guidelines were adopted after a period of public consultation with the targeted stakeholder consultation in the second half of 2018.

The Guidelines reflect the experience gained by the European Commission and the EMA in the field of ATMPs and in the assessment and authorisation of this type of medicinal products. Due to their complex nature, ATMPs present specific practical operational and regulatory challenges related to GCP compliance.Continue Reading Latest Updates on Good Clinical Practice for Advanced Therapies in the EU

Apologies that it has been a while since we’ve posted! We have lots in the pipeline, starting with this webinar.

Data and Its Impact on Medical Technology Companies Doing Business in the EU

Today’s medical technology industry is being transformed by data—clinical data, vigilance data, real world data and personal data. As such, there is…

On 23 January 2019, the European Data Protection Board (EDPB) adopted an Opinion on the interplay between the Clinical Trials Regulation (CTR), which is likely to become applicable in 2020 (if not later), and the European General Data Protection Regulation (GDPR). The Opinion focusses on an area provoking much discussion since the GDPR came into force; that is, as we discussed in our previous blog, which legal bases under the GDPR are appropriate for processing personal data in the context of clinical trials?

Continue Reading GDPR and clinical trials—more clarity?

As a New Year present to us all, on 3 January 2019, the MHRA published updated guidance on the regulation of medicines, medical devices and clinical trials in the event that the UK leaves the EU on 29 March 2019 without a deal, known as a “hard Brexit”.

Following publication of the technical notice in August 2018, which we considered in an earlier blog, a consultation was launched in order to seek views on the mechanics behind some of the proposals. The consultation ended on 1 November 2018; the responses were reviewed and the technical notice updated. However, the notice states in a number of places that further guidance will be published in due course.Continue Reading MHRA’s updated guidance on a hard-Brexit

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

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Publication of clinical trial data and results continues to be a hot topic in the EU. A recent BMJ article investigated the level of compliance with the European Commission’s requirement that the results of all trials are published within 12 months of completion. The Commission guidance expands on the obligations in the Clinical Trials Directive, and states that for all trials (paediatric and non-paediatric), result-related information should be supplied and made public within 12 months of the completion of the trial (not after grant of the marketing authorisation), including a summary of the results and conclusions.

The retrospective cohort study found that despite the Commission guidance, of the 7,274 trials where results were due, only 49.5% reported results, although trials with a commercial sponsor were substantially more likely to post results than those with a non-commercial sponsor (68.1% compared to 11.0%).Continue Reading Update on Clinical Trials Transparency in the EU

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

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