If you are aware of any news items that would be of interest to the RQA membership, please contact the RQA office.
We would like to inform you that the European Commission has launched a public consultation on European Health Data Space (EHDS), which aims to make full use of digital health to provide high-quality healthcare and reduce inequalities. It will promote access to health data for prevention, diagnosis and treatment, research and innovation, as well as for policy-making and legislation.
The International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO) are urging pharmaceutical companies to publish clinical trial reports for new medicines and vaccines without redactions to ensure that research results are publicly accessible to all those involved in healthcare decision-making. In a joint statement, they stress that systematic transparency can increase trust in regulatory decision-making, reassure the public about data integrity and can stimulate research and development, which could have a positive impact on vaccine confidence.
MHRA have produced a new 'Guidance on the licensing of biosimilar products'.
The International Council for Harmonisation (ICH) E6 on Good Clinical Practice (GCP) is currently undergoing a major revision.
With the move to electronic ways of working and integration of more electronic systems within a clinical trial, the MHRA GCP inspectorate has noticed that not all eSystems have been designed with the correct functionality in mind.
This month EMA’s safety committee (PRAC) reviewed a number of safety signals related to COVID-19 vaccines. The evaluation of safety signals is a routine part of pharmacovigilance and is essential to ensuring that regulatory authorities have a comprehensive knowledge of a medicine’s benefits and risks.
Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 13-15 April 2021
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 April 2021
FDA Authorises Marketing of First Device that Uses Artificial Intelligence to Help Detect Potential Signs of Colon Cancer. Medical device aids clinicians in detecting potential irregularities during colon cancer screening and surveillance
Regulatory status of equipment being used to help prevent coronavirus (COVID-19) - addition of section about transparent facemasks
Available to view now on YouTube.
FDA have published their Bioresearch Monitoring (BIMO) Fiscal Year 2020 Metrics
Fees payable to the MHRA for 2021 to 2022
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
Guidance for industry on preparing responses to good laboratory practice (GLP) and good clinical practice (GCP) inspection reports.
This toolkit is for Innovation Passport holders following the Innovative Licensing and Access Pathway (ILAP) and provides activities to support the design and development of medicines.
30 March 2021 Added new information on the inspector providing a verbal summary of GLP monitoring inspection findings. Added a link to a new page on responding to a GLP and GCP laboratory inspection report.
The MHRA GCP Stakeholder Engagement Meeting (StEM) now meets on an annual basis to provide a forum for discussion between the MHRA GCP inspectorate and represented stakeholders on key topics related to the conduct of clinical trials of investigational medicinal products....
The MHRA's latest post on it's inspectorate blog looks at how they have achieved over 750 remote inspections....
EMA’s human medicines committee (CHMP) recommended six medicines for approval at its February 2021 meeting.
EMA Management Board – highlights of March 2021 meeting Share
Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 16-18 March 2021
In line with current Government advice, the inspectorate will resume an on-site UK risk-based GxP inspection programme from 29 March 2021.
MRC - Identifiability, anonymisation and pseudonymisation article on Guidance note 5.
RSI in Clinical Trials: MHRA Findings and Tips - from Safety Observer
An interesting article written by Harry Mingay and Dr. Rita Hendricusdottir on the classification of IVD devices taken from Oxford Global Guidance.
ABOUT THE ECF REQUIREMENTS: The eClinical Forum has produced a set of Requirements, which are based upon statements in regulatory documents that pertain to the design, development, implementation, and management of electronic systems that support clinical research data as well as those statements that pertain to the handling of data that will be used in a regulated clinical trial. We have reviewed regulatory documents from the FDA, EMA, PMDA, NMPA and ICH to produce this set of requirements. Each Requirement has as its basis one or more statements from one or more of these regulatory documents. The Requirements can be used to determine if systems that data which will become part of a regulated clinical trial are consistent with regulatory requirements and if systems and process that manage these data have the necessary features.
EMA is pleased to announce a “Veterinary Big Data Stakeholder Forum” to be held virtually on 1-2 June 2021.
MHRA have published Pharmacovigilance inspection metrics April 2019 to March 2020.
Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 16-17 February 2021
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 February 2021
On behalf of the HMA-EMA Big Data Steering Group we are pleased to inform you of the upcoming “Technical workshop on real-world metadata for regulatory purposes” on Monday, 12 April 2021.
EMA Update on COVID-19 Vaccines
There is a third EMA public stakeholder meeting on the approval, safety monitoring and impact of COVID-19 vaccines in the EU to be held virtually on 26 March 2021 from 13:00 to 15:15 CET.
How to apply for marketing authorisation via this new procedure. MHRA have updated how to receive a 5 digit company number.
Questions and answers are being updated continuously and will be marked by “NEW” or “Rev.” with the relevant date upon publication. This guidance document addresses a number of questions which marketing authorisation holders (MAHs) may have on post-authorisation procedures. It provides an overview of the Agency’s position on issues, which are typically addressed in discussions or meetings with MAHs in the post-authorisation phase
The below Practical Guidance aims to provide procedural and practical guidance regarding submission of changes. It addresses the implications of the withdrawal agreement and the transition period provided for therein.
MHRA have been working hard to provide the guidance you need to become familiar with the pharmacovigilance requirements for UK marketing authorisation holders (MAH) which are set out in a revised legal framework.
Training is available from the European Medicines Agency (EMA) on how to use the Clinical Trials Information System (CTIS) ahead of its planned launch. EMA’s training resources are tailored for clinical trial sponsors and staff of the European Union (EU) Member States, European Commission and other organisations who will use the system. The training materials aim to help users comply with their obligations under the Clinical Trial Regulation (Regulation (EU) No 536/2014), which apply once the CTIS goes live. More information on the CTIS and the Clinical Trial Regulation is available on Clinical Trial Regulation.
The European Medicines Agency has published for public consultation a draft toolbox guidance on scientific elements and regulatory tools to support quality data packages for PRIME marketing authorisation applications.
Guideline on good pharmacovigilance practices (GVP) - Module XVI – Risk minimisation measures: selection of tools and effectiveness indicators (Rev 3) and Guideline on good pharmacovigilance practices (GVP) - Module XVI Addendum II – Methods for effectiveness evaluation
Since RSI blog posts part I and II were released, the MHRA GCP inspectorate has continued to see non-compliance in this key aspect of pharmacovigilance. Whilst additional guidance was released by the Heads of Medicines Agencies, Clinical Trials Facilitation and co-ordination Group (CTFG), we are still seeing unreported suspected unexpected serious adverse reactions (SUSARs) and absence of adequate risk mitigation measures due to incorrect use of the RSI.
The EU Commission published a new notice in the Official Journal of the EU on 25 January 2021 entitled "Application of the Union’s pharmaceutical acquis in markets historically dependent on medicines supply from or through Great Britain after the end of the transition period 2021/C 27/08)".
European Health Emergency Preparedness and Response Authority (HERA) - New health authority
Pharmacovigilance requirements for UK authorised products webinar recording, which took place on 13 January 2020. This webinar was part of a series of Brexit and post-transition guidance webinars.
An interesting article by the NHS HRA - Public involvement in a pandemic: lessons from the UK COVID-19 public involvement matching service.
New podcast series looks at innovation in trial design and study delivery during the COVID pandemic
HRA are launching HRA Now - a new way to share the changes that researchers and R&D professionals need to know about.
EMA has published an overview of its key recommendations in 2020 on the authorisation and safety monitoring of medicines for human and veterinary use.
CVMP adopts its workplan for 2021 and its strategy on antimicrobials for 2021-2025 CVMP opinions on veterinary medicinal products
The European Medicines Agency, EMA, is still planning with December 2021 for the go-live date of the EU Clinical Trials Information System (CTIS) database and portal, and thus with the first application of the Clinical Trial Regulation (CTR, Regulation (EU) No 536/2014).
Janet Woodcock was named Acting Commissioner of Food and Drugs on January 20, 2021.
Thanks to EUSurvey, the European Commission's tool, all Medical Devices Notified Bodies (n=54) received on September 28th, 2020, an invitation to the survey 'Notified Body Experience with Remote Auditing'. The survey was closed on October 29th. At that time, 37 Notified Bodies responded to the survey.
The way clinical trials are conducted in the EU will undergo a major change when the Clinical Trial Regulation (Regulation (EU) No 536/2014) comes into application. The Regulation harmonises the assessment and supervision processes for clinical trials throughout the EU, via a Clinical Trials Information System (CTIS). CTIS will contain the centralised EU portal and database for clinical trials foreseen by the Regulation and will be used by clinical trial sponsors as a single entry point in the EU to obtain approval for clinical trials based on applications and for monitoring clinical trials during their life cycle, including the submission of summary of results.
EMA is organising an webinar for industry on its Organisations Management Service (OMS) and Referentials Management Service (RMS) activities, on 03/02/2021 and 04/02/2021. While it is a general webinar, it will provide relevant information to sponsor organisations that will be using CTIS in future.
The transition period for the United Kingdom's departure from the EU is over and new guidance on a matter of topics has been released by the MHRA.
The strategy details how the European medicines regulatory network can continue to enable the supply of safe and effective medicines that meet patients’ needs in the face of challenges posed by ever-accelerating developments in science, medicine, digital technologies, globalisation as well as emerging health threats, such as the COVID-19 pandemic.
The new 'Guidance on interpretation and implementation' of the ECA Foundation and the PQG of the CQI
A blog post by Emanuela Krasteva and Peter Brown, 21 December 2020
EMA and the Heads of Medicines Agencies (HMA) have published their joint strategy for the next five years, following its recent adoption by the HMA and EMA Management Board.
EMA has published a Question & Answer on what type of studies are needed to approve a COVID-19 vaccine.
CTIS Highlights Newsletter
The European Medicines Agency has published information on the development and evaluation of vaccines for COVID-19.
Consideration on core requirements for RMPs of COVID19 vaccines coreRMP19 guidance Introduction/Background In addition to the EMA guidance on pharmacovigilance and vaccine development, the EMA will issue the “Pharmacovigilance Plan of the EU Regulatory Network for COVID-19 Vaccines” giving an overview of the monitoring activities to be carried out in the EU for COVID-19 vaccines, including the roles, responsibilities and interactions of the stakeholders involved. Further interactions between EMA, NCAs, and the vaccine manufacturers have identified the need to develop further guidance on RMP requirements for COVID-19 vaccines.
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 23-26 November 2020
Pharmacovigilance Plan of the EU Regulatory Network for COVID-19 Vaccines
EMA and the national competent authorities (NCAs) in EU Member States have prepared a safety monitoring plan for COVID-19 vaccines . The plan outlines how relevant new information emerging after the authorisation and uptake of COVID-19 vaccines in the pandemic situation will be collected and promptly reviewed.
Content added to Section 2.2, covering the country codes and worldwide case IDs which should be used.
On-site access to Electronic Health Records by Sponsor representatives in clinical trials The following guidance has been jointly developed by the Heath Research Authority (HRA) and MHRA, in consultation with the Information Commissioners Office (ICO), on behalf of the UK.
MRC Regulatory Support Centre Research Governance Survey Report November 2020
EMA will organise a public meeting on 11 December 2020 to inform European citizens about the EU regulatory processes for the approval of COVID-19 vaccines and the Agency’s role in their development, evaluation, approval and safety monitoring.
As well as the actions all travellers need to take, there are extra actions if you’re travelling to the EU for business. Business travel includes activities such as travelling for meetings and conferences, providing services (even with a charity), and touring art or music.
The International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO) have committed to working together to ensure that patients have access to safe and effective medicines against COVID-19 as early as possible.
ISO 22095 ‘Chain of Custody – General Terminology and Models’ has been published in October 2020, after three years of dedicated work from international chain of custody experts from industry associations, private companies, civil society organizations, governments and scheme owners. ISO 22095 is a simple solution that works across all sectors and with all materials and products. The new international standard allows users to effectively reduce their costs and address a multitude of issues caused by the present variety of chain of custody systems. Please find the ISO press release here. We will celebrate the publication of this horizontal standard in an international webinar ‘Launch of ISO 22095 on Chain of Custody’. The event will take place on the 9th of December 2020 at 14:00 hrs Brussel time zone (CET). Programme of the webinar: Content and highlights ISO 22095 ‘Chain of Custody’ – Mr. Adrian Henriques (projectleader) Case studies on how different organizations will implement the standard. Q&A session with experts that have been closely involved in the standard development process. You are cordially invited to join this webinar and share the information within your relevant netwerk. Please register yourself via this link. In case of any other questions related to this launch or the work of ISO/PC 308, please do not hesitate to contact the NEN Secretariat - Ms. Anne-Wil Broersma (firstname.lastname@example.org).
On 19 March, the MHRA first produced guidance for researchers on managing clinical trials of investigational medicinal products (IMPs) during the pandemic. This guidance constituted details about a collection of established flexibilities and technologies that are available, but little used, despite their regulatory acceptance.
Draft document available for comment.