On 7 September 2020, the European Data Protection Board (EDPB) initiated a public consultation on draft Guidelines 07/2020 on the concepts of controller and processor in the GDPR. Any interested party could provide comments by 19 October 2020 using the dedicated form.

The draft Guidelines contain elements that are of interest for companies active in the life science sector as they may have an impact on comapnies’ day-to-day research and commercial activities in the EU and their compliance with Regulation (EU) 2016/679 (GDPR).
Continue Reading Draft EU guidelines on the concepts of controller and processor—key elements for life sciences companies

Earlier this month, we commented on the European Commission proposal for a Regulation accelerating existing procedures for clinical trials where medicinal products containing or consisting of Genetically Modified Organisms (GMOs) are tested for the development of vaccines and therapies to treat COVID-19. The European Commission had proposed that, during the pandemic and by derogation to the GMO regulatory framework, the requirement of a prior environmental risk assessment or consent by the national competent authorities should not apply.
Continue Reading Update: Regulation for COVID-19 clinical trials conducted with medicinal products containing or consisting of GMOs has now been adopted

As part of the strategy to fight COVID-19, the European Commission has proposed a Regulation to facilitate the conduct of clinical trials using medicinal products containing or consisting of Genetically Modified Organisms (GMOs).

The European Commission recognises that the applicable regulatory framework in relation to GMOs is unable to adequately address the challenges created by the pandemic. While some vaccines in development contain attenuated viruses or live vectors, which may fall within the definition of a GMO, there is uncertainty on the interactions between the GMO regulatory framework and the legislation on clinical trials and medicinal products. This is further aggravated by the absence of a common approach by the EU Member States.
Continue Reading The European Commission proposes a Regulation for COVID-19 clinical trials conducted with medicinal products containing or consisting of GMOs

On 11 June 2020, the European Medicines Agency (EMA), during its Management Board meeting, has endorsed the methodology and next steps leading to the go-live of the Clinical Trials Information System (CTIS) which is now fixed for December 2021. A group consisting of representatives of the EU Member States and the European Commission has been set up to prioritise and coordinate all outstanding issues prior to go-live. The CTIS is the centralised EU portal and database for information storage foreseen by the Clinical Trials Regulation.  
Continue Reading EU Clinical Trials Regulation: The Clinical Trials Information System expected to go live by December 2021, according to the EMA

On 7 April 2020, the European Medicines Agency (EMA) issued a Notice to sponsors on validation and qualification of computerised systems used in clinical trials (Notice). This Notice was developed by the EMA’s GCP Inspectors Working Group (IWG) and the Committee for Medicinal Products for Human Use (CHMP) to highlight for clinical trial sponsors the legal and regulatory requirements which apply to software tools used in the conduct of clinical trials.

In addition, the EMA updated the Answers to Questions 8 and 9 of the Agency’s Q&A on Good Clinical Practice (GCP) (GCP Q&A) in line with the Notice.


Continue Reading EMA’s Notice on validation and qualification of software tools used in clinical trials

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

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

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

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.


Continue Reading UK Government’s Brexit White Paper