Recent News
If you are aware of any news items that would be of interest to the RQA membership, please contact the RQA office.
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EMA - public consultation on European Health Data Space (EHDS)
12th May 2021We 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.
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International regulators and WHO call for wider public access to clinical data
12th May 2021The 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.
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MHRA - Guidance on the licensing of biosimilar products
12th May 2021MHRA have produced a new 'Guidance on the licensing of biosimilar products'.
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MHRA - Virtual conference: The International Council for Harmonisation (ICH) E6 on Good Clinical Practice (GCP) Revision
12th May 2021The International Council for Harmonisation (ICH) E6 on Good Clinical Practice (GCP) is currently undergoing a major revision.
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MHRA - 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.
12th May 2021With 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.
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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 May 2021
12th May 2021This 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.
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EMA - Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 13-15 April 2021
20th April 2021Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 13-15 April 2021
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EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 April 2021
20th April 2021Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 April 2021
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FDA - First Device that Uses Artificial Intelligence
20th April 2021FDA 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
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MHRA - Transparent Facemasks
20th April 2021Regulatory status of equipment being used to help prevent coronavirus (COVID-19) - addition of section about transparent facemasks
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EMA - third public meeting on COVID-19 vaccines
7th April 2021Available to view now on YouTube.
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FDA - Bioresearch Monitoring (BIMO) Fiscal Year 2020 Metrics
7th April 2021FDA have published their Bioresearch Monitoring (BIMO) Fiscal Year 2020 Metrics
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MHRA - 2021-2022 Fees
7th April 2021Fees payable to the MHRA for 2021 to 2022
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MHRA - Innovative Licensing and Access Pathway
7th April 2021A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
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MHRA - Responding to a GLP and GCP laboratory inspection report
7th April 2021Guidance for industry on preparing responses to good laboratory practice (GLP) and good clinical practice (GCP) inspection reports.
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MHRA - The Target Development Profile Toolkit
7th April 2021This 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.
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MHRA - updates to GLP for safety tests on chemicals
7th April 202130 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.
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MHRA - Stakeholder Engagement Meeting March 2021
26th March 2021The 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....
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MHRA Inspectorate Blog: Inspectors grounded - a year of innovation
26th March 2021The MHRA's latest post on it's inspectorate blog looks at how they have achieved over 750 remote inspections....
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EMA - Highlights from CHMP 22-25 Feb 2021
22nd March 2021EMA’s human medicines committee (CHMP) recommended six medicines for approval at its February 2021 meeting.
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EMA - Management Board – highlights of March 2021 meeting
22nd March 2021EMA Management Board – highlights of March 2021 meeting Share
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EMA - Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 16-18 March 2021
22nd March 2021Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 16-18 March 2021
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MHRA to resume on-site inspections
22nd March 2021In line with current Government advice, the inspectorate will resume an on-site UK risk-based GxP inspection programme from 29 March 2021.
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MRC Article - Identifiability, anonymisation and pseudonymisation
22nd March 2021MRC - Identifiability, anonymisation and pseudonymisation article on Guidance note 5.
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RSI in Clinical Trials: MHRA Findings and Tips
22nd March 2021RSI in Clinical Trials: MHRA Findings and Tips - from Safety Observer
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What are the new device classifications in the In vitro Diagnostic Regulation (IVDR)?
22nd March 2021An interesting article written by Harry Mingay and Dr. Rita Hendricusdottir on the classification of IVD devices taken from Oxford Global Guidance.
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eClinical Forum - eCF Requirements PR2020
22nd March 2021ABOUT 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.
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EMA - Veterinary Big Data Stakeholder Forum
10th March 2021EMA is pleased to announce a “Veterinary Big Data Stakeholder Forum” to be held virtually on 1-2 June 2021.
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MHRA - Pharmacovigilance inspection metrics April 2019 to March 2020
3rd March 2021MHRA have published Pharmacovigilance inspection metrics April 2019 to March 2020.
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EMA - Highlights from CVMP Meeting 16-17 Feb 2021
23rd February 2021Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 16-17 February 2021
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EMA - Highlights from PRAC Meeting 8-11 Feb 2021
23rd February 2021Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 February 2021
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EMA - Technical workshop on real-world metadata for regulatory purposes
23rd February 2021On 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.
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EMA - Update on COVID-19 Vaccines
23rd February 2021EMA Update on COVID-19 Vaccines
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EMA - public stakeholders meeting on the approval, safety monitoring and impact of COVID-19 vaccines in the EU
23rd February 2021There 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.
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MHRA - registration on the MHRA Submissions Portal
23rd February 2021How to apply for marketing authorisation via this new procedure. MHRA have updated how to receive a 5 digit company number.
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EMA - Q&A - post-authorisation procedural advice for users of the centralised procedure
17th February 2021Questions 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
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HMA - CMDh - Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP
17th February 2021The 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.
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MHRA - Guidance on pharmacovigilance requirements for UK authorised products from 1 January 2021
12th February 2021MHRA 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.
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Clinical Trials Information System (CTIS): training programme
11th February 2021Training 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.
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EMA - Draft Toolbox for Consultation
5th February 2021The 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.
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EMA - GVP Guidelines for Consultation
5th February 2021Guideline 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
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MHRA Blog Post: Reference Safety Information (RSI) for Clinical Trials- Part III
5th February 2021Since 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.
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EU Commission - Brexit Notice on Medicinal Products
3rd February 2021The 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)".
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EU Commission - New Health Authority - feedback open
3rd February 2021European Health Emergency Preparedness and Response Authority (HERA) - New health authority
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MHRA - Pharmacovigilance requirements for UK authorised products - 13 January 2021
30th January 2021Pharmacovigilance 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.
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NHS HRA - Public Involvement in an Pandemic
28th January 2021An interesting article by the NHS HRA - Public involvement in a pandemic: lessons from the UK COVID-19 public involvement matching service.
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NHS HRA - Trial Design Podcast Series Now Available
28th January 2021New podcast series looks at innovation in trial design and study delivery during the COVID pandemic
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NHS Health Research Authority - HRA Now Newsletter
28th January 2021HRA are launching HRA Now - a new way to share the changes that researchers and R&D professionals need to know about.
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EMA - Human medicines and Veterinary: highlights of 2020
27th January 2021EMA has published an overview of its key recommendations in 2020 on the authorisation and safety monitoring of medicines for human and veterinary use.
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EMA - Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 19-20 January 2021
27th January 2021CVMP adopts its workplan for 2021 and its strategy on antimicrobials for 2021-2025 CVMP opinions on veterinary medicinal products
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EMA - Updated Timeline for the Clinical Trial Regulation
27th January 2021The 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).
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Janet Woodcock was named Acting Commissioner of Food and Drugs on 20 January, 2021.
27th January 2021Janet Woodcock was named Acting Commissioner of Food and Drugs on January 20, 2021.
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Medical Devices Notified Bodies Remote Auditing Survey
26th January 2021Thanks 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.
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EMA - SME and academia Clinical Trials Information System (CTIS) two-part training webinar
20th January 2021The 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.
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EMA - webinar for industry on OMS and RMS
20th January 2021EMA 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.
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New guidance and information for industry from the MHRA
4th January 2021The 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.
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EMA - Strategy to 2025
22nd December 2020The 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.
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GDP for APIs - New ECA/PQG Guide
22nd December 2020The new 'Guidance on interpretation and implementation' of the ECA Foundation and the PQG of the CQI
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MHRA - Qualifications of suppliers and customers online: reliable or fake news?
22nd December 2020A blog post by Emanuela Krasteva and Peter Brown, 21 December 2020
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EMA - Joint strategy sets direction for EMA and EU medicines regulatory agencies to 2025
15th December 2020EMA 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.
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EMA - Q&A -Types of Studies Needed to Approve a COVID-19 Vaccine
14th December 2020EMA has published a Question & Answer on what type of studies are needed to approve a COVID-19 vaccine.
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EMA - News, views and interviews for the Clinical Trials Information System (CTIS)
9th December 2020CTIS Highlights Newsletter
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EMA - COVID-19 Vaccines
2nd December 2020The European Medicines Agency has published information on the development and evaluation of vaccines for COVID-19.
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EMA - Consideration on core requirements for RMPs of COVID19 vaccines
1st December 2020Consideration 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.
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EMA - November 2020 PRAC Highlights
1st December 2020Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 23-26 November 2020
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EMA - Pharmacovigilance Plan of the EU Regulatory Network for COVID-19 Vaccines
1st December 2020Pharmacovigilance Plan of the EU Regulatory Network for COVID-19 Vaccines
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EMA publishes safety monitoring plan and guidance on risk management planning for COVID-19 vaccines
1st December 2020EMA 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.
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MHRA - Guidance on pharmacovigilance procedures from 1 January 2021
1st December 2020Content added to Section 2.2, covering the country codes and worldwide case IDs which should be used.
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MHRA - On-site access to Electronic Health Records by Sponsor representatives in clinical trials
1st December 2020On-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.
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MRC Regulatory Support Centre Research Governance Survey Report
1st December 2020MRC Regulatory Support Centre Research Governance Survey Report November 2020
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EMA organises public meeting on COVID-19 vaccines
30th November 2020EMA 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.
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Visit Europe from 1 January 2021
30th November 2020As 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.
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EMA - International regulators and WHO join forces to address COVID-19 challenges
18th November 2020The 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.
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Launch Event ISO 22095 ‘Chain of Custody’
18th November 2020ISO 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 (anne-wil.broersma@nen.nl).
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MHRA - Building resilience into clinical trial design and conduct during the pandemic
18th November 2020On 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.
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WHO - Good practices for research 6 and development facilities
18th November 2020Draft document available for comment.
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