If you are aware of any news items that would be of interest to the RQA membership, please contact the RQA office.
Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders - now available.
Expert and lay members of UK RECs recognised to review Clinical Trials of Investigational Medicinal Products (CTIMPs) or Phase 1 studies in healthy volunteers, particularly those with experience of vaccine studies, were invited to join an ad hoc Research Ethics Committee to review SARS COV 2 Human Infection Challenge studies (HICS). All were asked to attend two virtual HRA workshops before the first committee meeting (and all did!) and were provided with articles from both sides of the argument for further reading. Given the pandemic lockdown, we met virtually, ensuring broad representation across the UK nations, and that applicants were easily able to attend (of huge help to our review).
'Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials' and 'Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials'.
The European Commission has confirmed that the entry into application of the Clinical Trials Regulation and hence the go-live date for the Clinical Trials Information System (CTIS) will be on 31 January 2022.
Draft working document for comments.
Information for participants who are involved in the submission of applications for Clinical Trials of Investigational Medicinal Products (CTIMPs).
DRAFT WORKING DOCUMENT FOR COMMENTS
Produced by Pharmaceutical Inspection Convention - Pharmaceutical Inspection Co-Operation Scheme
A new blog post from MHRA. Too good to be true? How to play your part in protecting the UK medicines supply chain
We need a global network of ‘living’ biofoundries. CEPI (Coalition for Epidemic Preparedness Innovations) and Wellcome Leap are collaborating on establishing a global network of ‘living’ biofoundries.
Meeting highlights from the Committee for Medicinal Products for Veterinary Use
MHRA’s new Chief Safety Officer, Dr Alison Cave, starts vital vigilance work today
The collaboration aims to support China’s regulator in strengthening their regulatory capacity to improve patient access to safe and high-quality medicines and to promote global health security.
Clinical Trials Information System (CTIS) webinar: How sponsor organisations can prepare for CTIS
EMA consultation: Guidelines on the requirements for quality documentation concerning medicinal products in clinical trials
GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS
RQA is collating responses to the EMA’s public consultation on the EMA “Guideline on computerised systems and electronic data in clinical trials
Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 15-17 June 2021 - CVMP opinions on veterinary medicinal products
Latest edition of the EMA Clinical Trials Information System (CTIS) Newsletter
The implementation plan published on 23rd June 2021 sets out the first year of activities towards delivering the vision for The Future of UK Clinical Research Delivery.
Public consultation Following several internal rounds of consultation and extensive discussion between PIC/S Members on draft versions of PIC/S Annex 16, the PIC/S Committee recently agreed to proceed to Step 2 of the PIC/S consultation process.
EMA has published its 2020 annual report that provides an overview of the Agency’s major achievements and contributions to public health in Europe.
EMA is establishing a coordination centre to provide timely and reliable evidence on the use, safety and effectiveness of medicines and vaccines, from real world healthcare databases across the EU. The initiative is called Data Analysis and Real World Interrogation Network, or simply #DARWINEU. It will connect the European medicines regulatory network to the European Commission's European Health Data Space (EHDS), an initiative to promote better exchange and access to different types of health data. DARWIN EU will enable EMA and national competent authorities in the European medicines regulatory network to draw on valid and reliable evidence whenever needed throughout the lifecycle of a medicinal product.
Regulation (EU) 2017/745 on medical devices becomes applicable in the European Union today, 26 May 2021.
Meeting highlights for PRAC held 7th - 10th June 2021
Reflection paper on forecasting demand for medicinal products in the EU/EEA Published 3rd June 2021
Open Consultation - Survey
Great Britain Marketing Authorisations (MAs) for Centrally Authorised Products (CAPs) An updated list of PLGB numbers for the grandfathering of CAP MAs.
A framework for restarting NIHR research activities which have been paused due to COVID-19
These two process maps were developed by the UK Vaccine R&D Network, to show key stages in both human vaccine development and veterinary vaccine development up to Phase III clinical trials or veterinary field trials. The Network is supporting vaccine R&D against some of the world's deadliest outbreak infectious diseases, and these process maps are intended to support Network members in understanding key stages in human and veterinary vaccine development and where bottlenecks could potentially delay progress.
Today, the European Commission adopted two sets of standard contractual clauses, one for use between controllers and processors and one for the transfer of personal data to third countries.
Annual report from the MHRA on the regulation of medicines advertising to promote transparency.
Highlights of the committee meeting.
CVMP opinions on veterinary medicinal products
This guidance provides a framework to facilitate the management of post approval chemistry, manufacturing, and controls (CMC) changes in a more predictable and efficient manner. The guideline is intended to complement the existing ICH Q8 to Q11 Guidelines, and is composed of a Core Guideline and two Annexes.
Notify the MHRA about a clinical investigation for a medical device - update to guidance concerning Northern Ireland.
#Red4Research Day on Friday 18th June 2021
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.