News

Last weeks round-up; 13 -17 April 2020

published 20 Apr 2020

HPRA NEWS: EXPEDITED REGULATORY AND ETHICS REVIEW IN IRELAND

The HPRA, in conjunction with the Department of Health, the National Office for Research Ethics Committees and the Health Research Declaration Committee (HRCDC), have agreed an expedited review process for human health research related to the current pandemic, further details can be found here https://bit.ly/2Kaun4g. A key development is the establishment of a dedicated COVID-19 national research ethics committee (NREC-COV19) by the Minister for Health. In the interests of time and resource efficiency, applications for ethical review of all human health research studies related to COVID-19 should be submitted to the NREC-COV19. Applications for clinical trials of human medicines, or clinical investigations of medical devices, will be given a priority and expedited review by the HPRA and the NREC-COV19 will review applications concurrently with regulatory review processes and will endeavour to facilitate an expedited ethical review. https://bit.ly/2KbtXuq

EMA INSPECTIONS OFFICE, NOTICE TO SPONSORS ON VALIDATION AND QUALIFICATION OF COMPUTERISED SYSTEMS USED IN CLINICAL TRIALS

Given recent inspection findings and the implications they have had on the integrity, reliability, robustness and acceptability of data in the context of MAAs, the GCP Inspectors Working Group (IWG) in cooperation with the Committee for Medicinal Products for Human Use (CHMP) sees the need to emphasize requirements for sponsors/vendors providing computerised systems or services as well as for the qualification and validation of computerised systems used to manage clinical trial data. The notice stresses “Data integrity, reliability and robustness will depend on the design and the validation status of the computerised systems used. Failure to document and therefore demonstrate the validated state of a computerised system is likely to pose a risk to data integrity, reliability and robustness, which depending on the criticality of the affected data may result in a recommendation from the GCP inspectors to the CHMP not to use the data within the context of an MAA.” The full text is available here https://lnkd.in/e8PfiZ5 and also refers the reader to Q8 and Q9 from the good clinical practice (GCP) Q&As published on the EMA website.

EMA SUBMISSION DEADLINES FOR PAEDIATRIC APPLICATIONS 2020/2021

EMA has just published its submission deadlines for PIP applications for the period 2020/2021. The tabulation can be found here https://lnkd.in/e2hbhUz. Please also note that, per our previous post on 25th March 2020, a letter of intent for PIPs and PIP waivers is no longer required.

EC NEWS: COVID-19: GUIDANCE ON MORE REGULATORY FLEXIBILITY FOR MEDICINES

The European Commission, EMA and the European medicines regulatory network have developed a Q&A document to provide guidance to stakeholders on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic. The document published today outlines areas where regulatory flexibility is possible to address some of the constraints marketing authorisation holders may be faced with in the context of COVID-19. The document outlines areas where regulatory flexibility is possible to address some of the constraints marketing authorisation holders may currently be faced with. https://lnkd.in/d5SY6z2

EMA HAS ESTABLISHED A COVID-19 EMA PANDEMIC TASK FORCE (COVID-EFT)

EMA has issued a document outlining the ‘Mandate, objectives and rules of procedure of the COVID-19 EMA pandemic Task Force (COVID-ETF)’. EMA has the mandate under the Health Threat plan to convene specific expert groups such as the EMA Task Force (ETF) to assist the CHMP, PRAC and PDCO or take part on behalf of the CHMP in early scientific discussions and products reviews as needed. This methodology has helped greater coordination in previous outbreaks. In the context of the COVID19 pandemic, and following a call from Member States (MSs) and European Institutions, the composition and the objectives of the ETF have been modified in order to better support the regulatory activities and public health needs of the Member States and the European Commission during this pandemic. Full details can be found https://lnkd.in/dz6BV8J