If you are aware of any news items that would be of interest to the RQA membership, please contact the RQA office.
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.
PRAC reviews EMA guidance on risk management plan requirements for COVID-19 vaccines
An EMA Clinical Trial Information System (CTIS) webinar (dynamic demo of sponsor workspace) took place on 21 September 2020. Materials are currently available to participants who registered to attend via DIA, however EMA have indicated that they plan to make the demonstrations publicly available on their website at a later date, as part of their wider training of CTIS users and Sponsors.
The UK has left the EU, and the transition period after Brexit comes to an end this year. The Agency is making preparations to ensure that you can continue to submit regulatory and notification information to the UK.
On 22 October 2020, EMA will mark 25 years of its strong commitment to protect public and animal health with a virtual conference. The event will be broadcast live on EMA’s website.
How the Medicines and Healthcare products Regulatory Agency (MHRA) makes decisions on what is a medicine or medical device (borderline products).
Medicines and Healthcare products Regulatory Agency (MHRA) good manufacturing practice (GMP) deficiencies since April 2010.
Sponsors of UK clinical trials that import investigational medicinal products (IMPs) into Great Britain from outside the UK will need to review their existing supply chains. Where the product is sourced from a country on the ‘approved country for import list’, this will include a UK Manufacturing and Import Authorisation (MIA(IMP)) holder putting in place an assurance system to check these IMPs have been certified by a Qualified Person (QP) in a listed country, before release to trial sites. The list of approved countries will initially include all EU and EEA countries. IMPs imported into Great Britain from outside the UK that have been QP certified in a listed country will not require recertification in Great Britain. The purpose of this guidance is to describe the principles for the management and oversight of the import of IMPs to Great Britain from listed countries. There will be a one-year transition period from 1 January 2021.
The Medicines and Healthcare products Regulatory Agency (MHRA) is the latest regulator to join the Australia-Canada-Singapore-Switzerland (ACSS) Consortium.
This guidance currently covers Article 41. We will update this guidance to cover all aspects of supplying medicines to Northern Ireland from 1 January 2021 in due course.
There can be a degree of uncertainty when it comes to writing and formatting an expert report. Companies will often ask questions.
Two new exciting virtual events to support the health & care R&D community.
EMA’s human medicines committee (CHMP) has started the first ‘rolling review’ of a COVID-19 vaccine, which is being developed by the company AstraZeneca in collaboration with the University of Oxford.
The October 2020 meeting of the Management Board focused in particular on the Agency’s activities in response to the COVID-19 pandemic. The meeting was Guido Rasi’s final Board meeting as EMA’s Executive Director before Emer Cooke takes the helm in mid-November.
From 19 October 2020, developers of human or veterinary medicines should use EMA’s IRIS Regulatory & Scientific Information Management Platform to request scientific advice.
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 September - 1 October 2020
Workshop on Support for Orphan Medicines Development - 30 November 2020.
RQA NEWS - GLP news pages updated for members
Animal and Vet Products News Updated on the website - for members
GCP News Pages updated for members
BSI are keen to get as much UK input to a user survey of ISO9001 as possible.
EMA has published its draft Guideline on registry-based studies for a three-month public consultation. The new draft guidance aims to optimise the use of registry-based studies as a source of real-world evidence.
The European Medicines Agency has published for public consultation a revised draft of the ICH guideline Q3D (R2) on elemental impurities - Step 2.
A Pharmaceutical Quality Webinar for Global Stakeholders Held: 23rd July, 2020
What measures have EMEA governments taken in the life sciences sector to fight COVID-19?
The Big Data Steering Group set up by EMA and the Heads of Medicines Agencies (HMA) has published its workplan which sets actions to be delivered in 2020-21.
A blog by Callum McLoughlin.