Transitioning trials from the Clinical Trials Directive (CTD) to the Clinical Trials Regulation (CTR)
A new guidance was released on Transition of clinical trials from CTD to CTR. This Guidance supersedes the chapter 11 of the Questions & Answers on the application of the EU Clinical Trials Regulation (version 6.4).
Additional guidance advises Sponsors of multinational clinical trials with different protocol versions approved in different Member States to follow the Best Practice Guide and cover letter template when transitioning their trials from CTD to CTR.
EMA issued a draft reflection paper on the use of artificial intelligence (AI).
This paper is open for public consultation and reflects on principles relevant to the application of AI and machine learning at any step of a medicines’ lifecycle, from drug discovery to the post-authorisation setting.
Consultation ends 31 December 2023
Coordinated clinical trials in public health emergencies
EMA published a report on lessons learned on Clinical Trials (CTs) in Public Health Emergencies. This highlights the need to improve the way CTs are set up and conducted in the EU during crisis times to ensure that sufficient evidence is rapidly gathered from adequately sized clinical trials across multiple Member States to support rapid access to treatments and vaccines.
Phasing out of extraordinary COVID-19 regulatory flexibilities
The World Health Organsiation (WHO) declared an end to the COVID-19 public health emergency
in May 2023. As a result the EMA, the European Commission (EC) and the Heads of Medicines Agencies (HMA) are now phasing out
the extraordinary regulatory flexibilities for medicines put in place during the pandemic to help address regulatory and supply challenges arising from the pandemic.
On-site good manufacturing practice (GMP) and good distribution practice (GDP) inspections
have already restarted, however, because of the considerable number of postponed inspections the validity of GMP and GDP certificates has currently been extended until the end of 2023, and the GMDP Inspectors Working Group will issue in the coming months an update on the approach for 2024.
The following two regulatory and procedural guidelines contain multiple updates:
For a centralised procedure there is a single application, a single evaluation and a single authorisation throughout the European Union. Only certain medicines are eligible for the centralised procedure.
Newsletter: SME Office – Issue 59, July 2023
The bulletin highlights news, documents, and activities of interest to SMEs and their stakeholders.
Newsletter: Clinical Trials Highlights – Issue 15, July 2023
Provides the latest news on clinical trials from the European Medicines Regulatory Network (EMRN), including news on the joint Accelerating Clinical Trials in the EU (ACT EU) initiative and on the Clinical Trials Information System (CTIS).