In May 2021, the U.S. Food and Drug Administration (FDA) published a draft guidance (Draft Guidance) addressing the requirement for all investigators involved in clinical trials conducted under a U.S. Investigational New Drug (IND) application to sign Form FDA 1572. This includes investigators in clinical trial sites outside the U.S.

By signing Form FDA 1572 (Form 1572), the investigator of a drug or biologic trial warrants that they and any listed staff have the experience and background needed to conduct the trial and agrees to comply with the protocol and all applicable U.S. regulatory provisions governing the conduct of clinical trials.  From an FDA standpoint, it provides a clear basis of responsibility (and potential liability) under the applicable clinical trial regulations (21 CFR 312) for those who sign the form.  It also raises questions about the extent of FDA’s extraterritorial reach over non-U.S. investigators who conduct IND studies outside of the United States.


Continue Reading FDA Guidance on Clinical Investigators Signing Form FDA 1572 and Practical Challenges Outside the US

The UK MHRA has issued draft guidance on randomised controlled trials generating real-world evidence (RWE) that is used to support regulatory decisions. It is intended to be the first in a series of guidance documents addressing RWE. The guidance is part of the MHRA’s push to reinforce the view of the MHRA as a pro-innovative regulatory authority, and that the UK is a leading country in which to conduct clinical research, post-Brexit.

Continue Reading UK MHRA consultation on real-world evidence

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

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 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