Recent News
If you are aware of any news items that would be of interest to the RQA membership, please contact the RQA office.
-
EMA - COVID-19 Vaccines
2nd December 2020The European Medicines Agency has published information on the development and evaluation of vaccines for COVID-19.
Read More+ -
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.
Read More+ -
EMA - November 2020 PRAC Highlights
1st December 2020Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 23-26 November 2020
Read More+ -
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
Read More+ -
EMA 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.
Read More+ -
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.
Read More+ -
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.
Read More+ -
MRC Regulatory Support Centre Research Governance Survey Report
1st December 2020MRC Regulatory Support Centre Research Governance Survey Report November 2020
Read More+ -
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.
Read More+ -
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.
Read More+ -
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.
Read More+ -
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).
Read More+ -
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.
Read More+ -
WHO - Good practices for research 6 and development facilities
18th November 2020Draft document available for comment.
Read More+ -
EMA - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26-29 October 2020
4th November 2020PRAC reviews EMA guidance on risk management plan requirements for COVID-19 vaccines
Read More+ -
EMA - Clinical Trial Information System (CTIS) webinar
3rd November 2020An 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.
Read More+ -
MHRA - Registering to make submissions to the MHRA from 1 January 2021
23rd October 2020The 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.
Read More+ -
EMA - virtual conference: 25 years of advancing public and animal health
21st October 2020On 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.
Read More+ -
MHRA - Decide if your product is a medicine or a medical device
21st October 2020How the Medicines and Healthcare products Regulatory Agency (MHRA) makes decisions on what is a medicine or medical device (borderline products).
Read More+ -
MHRA - Good manufacturing practice inspection deficiencies
21st October 2020Medicines and Healthcare products Regulatory Agency (MHRA) good manufacturing practice (GMP) deficiencies since April 2010.
Read More+ -
MHRA - Importing investigational medicinal products into Great Britain from approved countries from 1 January 2021
21st October 2020Sponsors 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.
Read More+ -
MHRA - Joins Australia-Canada-Singapore-Switzerland (ACSS) Consortium
21st October 2020The Medicines and Healthcare products Regulatory Agency (MHRA) is the latest regulator to join the Australia-Canada-Singapore-Switzerland (ACSS) Consortium.
Read More+ -
MHRA - Supplying medicines to Northern Ireland from 1 January 2021
21st October 2020This 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.
Read More+ -
MHRA Blog Post: Expert reports - what’s expected!
21st October 2020There can be a degree of uncertainty when it comes to writing and formatting an expert report. Companies will often ask questions.
Read More+ -
NHS R&D Forum - Save the Date
16th October 2020Two new exciting virtual events to support the health & care R&D community.
Read More+ -
EMA - 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
7th October 2020EMA’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.
Read More+ -
EMA - Highlights of Management Board: October 2020 meeting
7th October 2020The 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.
Read More+ -
EMA - New online platform for scientific advice
7th October 2020From 19 October 2020, developers of human or veterinary medicines should use EMA’s IRIS Regulatory & Scientific Information Management Platform to request scientific advice.
Read More+ -
EMA - PRAC Meeting Highlights
7th October 2020Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 September - 1 October 2020
Read More+ -
EMA - Workshop on Support for Orphan Medicines Development
7th October 2020Workshop on Support for Orphan Medicines Development - 30 November 2020.
Read More+ -
RQA NEWS - GLP news pages updated 71020
7th October 2020RQA NEWS - GLP news pages updated for members
Read More+ -
RQA News - Animal and Vet Products News Updated
7th October 2020Animal and Vet Products News Updated on the website - for members
Read More+ -
RQA News - GCP News Page Updated
7th October 2020GCP News Pages updated for members
Read More+ -
ISO 9001 User Survey for 2020
30th September 2020BSI are keen to get as much UK input to a user survey of ISO9001 as possible.
Read More+ -
EMA - Guideline on registry-based studies
29th September 2020EMA 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.
Read More+ -
EMA - revised draft of the ICH guideline Q3D (R2) on elemental impurities - Step 2.
29th September 2020The European Medicines Agency has published for public consultation a revised draft of the ICH guideline Q3D (R2) on elemental impurities - Step 2.
Read More+ -
A Pharmaceutical Quality Webinar for Global Stakeholders
23rd September 2020A Pharmaceutical Quality Webinar for Global Stakeholders Held: 23rd July, 2020
Read More+ -
COVID-19 EMEA - Life Sciences Survey
16th September 2020What measures have EMEA governments taken in the life sciences sector to fight COVID-19?
Read More+ -
EMA - Big Data Steering Group workplan for 2020-21
16th September 2020The 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.
Read More+ -
MHRA - Investigations in the GMDP environment
16th September 2020A blog by Callum McLoughlin.
Read More+ -
Make it Public: transparency and openness in health and social care research
3rd September 2020Why research transparency is important The UK has a thriving health and social care research environment. More people take part in research studies each year, and donations to medical research charities are on the rise. Health and social care research findings translate into better care for patients and service users, and improvements to our health and wellbeing. They also lead to economic growth. Scientific and medical publishing has become more open over recent years and new initiatives are driving towards research findings being ever more freely available. This is making research findings more accessible to researchers and others working in health and social care. However, the people who take part in research studies want to know about the findings of research too. Transparency about what research is going on, and what its findings are, is important for patients, service users and the public. It builds trust and accountability, acknowledges their contribution and encourages participation in research. It’s also essential for research and care professionals. It leads to improvements and avoids duplication of effort. It enables findings to be used to develop new and better treatments for patients and service users, and to identify the best ways for us to stay healthy and well. It also helps improve the quality of research. When research is carried out openly and transparently, everyone benefits: patients and the public can see what research is taking place or has completed, and access clear information about the results patients, service users and carers can find out about research that is relevant to them, giving them the opportunity to join studies health professionals, commissioners, researchers, policy makers and funders can use research findings to make informed decisions
Read More+ -
ARSAC notes for guidance: good clinical practice in nuclear medicine
2nd September 2020Guidance on licencing and best use of radiopharmaceuticals and sealed radioactive sources in diagnosis, treatment or research.
Read More+ -
EU: Checklist for Brexit Preparation
2nd September 2020The end of the transition period is approaching and no agreement is in sight. Having first published a Communication to prepare for the end of the transition period, the European Commission has now published a respective 'Brexit Readiness Checklist' for companies doing business with the UK. This checklist is designed to help EU companies doing business in the UK (United Kingdom; UK) and/or UK companies doing business in the EU to check exactly how well prepared they are for 1 January 2021.
Read More+ -
MHRA - Brexit Transition
2nd September 2020Guidance for industry and organisations to follow from 1 January 2021 issued by the UK Government.
Read More+ -
MHRA - Changes from 1st January 2021
2nd September 2020The MHRA have released lots of documents relating to Brexit and the changes that will need to implemented on 1st January 2021 so it is worth taking a look at their news area.
Read More+ -
MHRA - List of approved countries for authorised human medicines from 1 January 2021
2nd September 2020Approved countries for batch testing and importation of medicines from 1 January 2021
Read More+ -
MHRA - preparing to make submissions to the MHRA from 1 January 2021
2nd September 2020Webinars for pharmaceutical companies, clinical trial sponsors, e-cigarette producers and brokers of medicinal products about new MHRA systems to use from 1 January 2021.
Read More+ -
Helping you navigate the world of medical device regulation
27th August 2020Oxford Global Guidance Helping you navigate the world of medical device regulation A digital tool to make it easier to understand how medical device regulations apply to your product.
Read More+ -
RQA News - JSQA / RQA Collaboration Pharmacovigilance Quality Systems
27th August 2020Members Only Both Japan and the European Union have highly advanced and defined legislation and regulatory expectations for pharmacovigilance. JSQA and RQA have previously collaborated on an overview document for all pharmacovigilance requirements. In this collaboration an analysis of EU and Japan Quality Management Systems (QMS) to support pharmacovigilance as described in legislation and guidance documents is presented. In this collaborative exercise we provide a comparison of these requirements.
Read More+ -
RQA News - PV Legislative Update
27th August 2020Members Only August 2020 Version
Read More+ -
MHRA - Cross Contamination Control in Shared Facilities and Equipment. Reflection on common deficiencies and expectations as seen in recent PIC/S guidance.
19th August 2020Graeme McKilligan During this period where MHRA has been conducting predominantly remote inspections, we have reflected on some of the common factors in critical deficiencies we have been seeing in control strategies for cross contamination between products in shared facilities. Requirements and expectations have been refreshed with Inspectors with a particular focus of attention on sites handling products with lower level Health Based Exposure Levels (HBELs), those with products around the red area of the continuum seen in the PIC/S Q&A document,
Read More+ -
OECD - Draft Guidance Documents on Good Laboratory Practice (GLP) for public comments
19th August 2020On 07 August 2020, the OECD made OECD Draft Advisory Document on GLP Data Integrity for public comment.
Read More+ -
PIC/S publishes Aide-Memoire for the Inspection of Health Based Exposure Limit
19th August 2020In June, the Pharmaceutical Inspection Convention/Cooperation Scheme (PIC/S) issued the new document PI 052-1. What is in it?
Read More+ -
Guidance for industry on MHRA’s expectations for return to UK on-site inspections
11th August 2020The MHRA are planning to resume on-site UK risk-based GxP inspections in September.
Read More+ -
International Standard For Medical Device Testing Updated
4th August 2020ISO 14155:2020 - Clinical investigation of medical devices for human subjects — GCP Patient safety is a key focus in update of ISO 14155, the industry reference for good practice in clinical trials.
Read More+ -
MHRA - GCP Serious Breaches update
4th August 2020The annual metrics report for GCP referrals has now been published for 2019. In 2019, MHRA received a total of 112 serious breach notifications, of which: 75 were deemed to be a serious breach 36 deemed not to be a serious breach 1 awaiting further information to enable final determination...
Read More+ -
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2020
29th July 2020EMA’s human medicines committee (CHMP) recommended eleven medicines for approval at its July 2020 meeting, including a medicine for use in countries outside the European Union.
Read More+ -
RQA NEWS - GLP news pages updated
28th July 2020The GLP News pages on the website have been updated today.
Read More+ -
EMA consultation: Concept paper for the development of a reflection paper on criteria for the application of Article 40(5) of Regulation (EU) 2019/6
23rd July 2020The European Medicines Agency has published for public consultation for a concept paper for the development of a reflection paper on criteria for the application of Article 40(5) of Regulation (EU) 2019/6.
Read More+ -
MHRA planning for return to on-site Good Practice (GxP) inspections
23rd July 2020Starting in September, MHRA is making careful preparations for a safe return to normal UK on-site inspection scheduling.
Read More+ -
China - Guiding Principles for the Preservation of Prepared Documents
22nd July 2020China - Circular of the State Food and Drug Administration on Issuing the Guidelines for the Preservation of Essential Documents for Drug Clinical Trials
Read More+ -
EMA published for public consultation on a draft access policy: Union Product Database Access Policy (UPD) - Veterinary Medicinal Products.
22nd July 2020Veterinary stakeholders are invited to comment on a draft access policy for the Union Product Database, which will provide information on all authorised veterinary medicines and their availability in EU Member States. The access policy sets out the types of information different user groups should be allowed to access once the database becomes operational in January 2022. Implementation of the Union Product Database is required by the new Veterinary Medicines Regulation. For more information, see Implementation of the new Veterinary Medicines Regulation. Stakeholders should submit comments on the access policy to vetchange.programme@ema.europa.eu by 18 September 2020.
Read More+ -
First edition of the Veterinary Medicines Regulation Highlight
22nd July 2020First edition of the Veterinary Medicines Regulation Highlight - July 2020
Read More+ -
Pharmacovigilance Audits and Inspections during COVID-19
22nd July 2020The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) released a Q&A document on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic. The document is updated continuously and includes Q&As relating to pharmacovigilance.
Read More+ -
MHRA - A Practical example of applying Quality Risk Management in GDP – Transportation Risks
15th July 2020What is your biggest GDP risk? If you had to think about the answer, then it is likely that you haven’t given it much thought. Quality Risk Management (QRM) is a requirement of Good Distribution Practice (GDP). It underpins good design and maintenance of a GDP quality system and provides an approach that enables the quality system to be safe for patients, efficient and effective through identification of risks, and facilitates proportionality of mitigation....
Read More+ -
Medical devices given exceptional use authorisations during the COVID-19 pandemic
14th July 2020List of manufacturers and their medical devices which have been granted an exemption by the MHRA
Read More+ -
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 July 2020
14th July 2020At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines: assessment of safety signals, risk management plans, periodic safety update reports and post-authorisation safety studies.
Read More+ -
International regulators provide guiding principles for COVID-19 clinical trials
6th July 2020EMA has endorsed a joint statement on prioritisation of COVID-19 clinical trials published by the International Coalition of Medicines Regulatory Authorities (ICMRA).
Read More+ -
Q&A - List for the submission of variations according to Commission Regulation (EC) 1234/2008
2nd July 2020Changes to the Q&A published in May 2020.
Read More+ -
QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC
2nd July 2020QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC - Update to Q&A document released by EMA, EC and HMA. Updated 1st July 2020.
Read More+ -
MHRA and FDA Joint Paper 'Data Integrity in Global Clinical Trials'
30th June 2020Following on from the successful 2-day event in Washington in October 2018 where MHRA GCP Inspectors (Gail Francis, Steve Vinter and Andy Fisher) and US FDA joined forces to discuss data integrity, MHRA and FDA have produced a joint paper ‘Data Integrity in global Clinical Trials’ authored by those who presented at the event.
Read More+ -
EMA - Academia fee waiver for scientific advice
23rd June 2020The EMA is pleased to inform you about the decision to waive all fees for scientific advice for academic researchers developing orphan medicines, to further encourage the development of treatments for rare diseases.
Read More+ -
EMA - Pharmaceuticals – safe and affordable medicines (new EU strategy)
23rd June 2020About this initiative: Summary The EU is launching a new strategy to improve and accelerate patients’ access to safe and affordable medicines and to support innovation in the EU pharmaceutical industry. It will address: • the life cycle of medicines from R&D to authorisation and patient access • how to put scientific and technological advances into practice • how to fill market gaps (e.g. new antimicrobials) • lessons learnt from COVID-19 on how to better prepare for future pandemics. Topic: Public health Type of act: Communication Category: Commission Work Programme
Read More+ -
Have your say on the future development of ISO 9000 and ISO 9001
23rd June 2020The current editions of ISO 9000, Quality management systems Fundamentals and vocabulary, and ISO 9001, Quality management systems Requirements, were published in 2015. Both standards will shortly be up for a systematic review as required by the ISO Directives. The choices available for what happens to the standards are: Confirm, Revise/Amend, Withdraw, or Abstain.
Read More+ -
ISO 9001 Auditing Practices Group Guidance on: REMOTE AUDITS
23rd June 2020Remote auditing is one of the audit methods described in ISO 19011:2018 Annex A1. The value of this audit method resides in its potential to provide flexibility to achieving the audit objectives. In order to realize the benefits of this audit method, all interested parties should be aware of their role in the process, inputs, expected outputs, and risks and opportunities that will provide the basis to achieve the audit and audit program objectives.
Read More+ -
Survey assessing the Member States’ rules on health data in the light of GDPR
23rd June 2020Request for comments from EMA.
Read More+ -
Opportunities for patients and the public to be involved in the work of the MHRA
17th June 2020How the MHRA engage and involve patients and the public in our regulatory decision-making. Updated 15th June 2020.
Read More+ -
Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice
17th June 2020FDA/CTTI Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice - meeting materials
Read More+ -
Good Clinical Practice Symposium 2020
16th June 2020Between 11 and 14 February 2020, the MHRA hosted a week-long series of events as part of the Good Practice Symposia Week. This included individual events from the GPvP, GCP and Laboratories Inspectorates where a host of regulators and delegates from across the globe came together.
Read More+ -
Guidance on remote GCP Inspections - 10th June 2020
15th June 2020Guidance on remote GCP inspections during the COVID19 pandemic This document is intended to provide guidance on the steps to be followed during remote good clinical practice (GCP) inspections.
Read More+ -
ICH E6(R3) Good Clinical Practice workshop with Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties
15th June 2020A virtual workshop on the renovation of the ICH guideline on Good Clinical Practice E6, further to the discussions during the March 2020 PCWP/HCPWP Joint meeting. Presentations available.
Read More+ -
Meeting highlights from the PV Risk Assessment Committee (PRAC)
15th June 2020At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines: assessment of safety signals, risk management plans, periodic safety update reports and post-authorisation safety studies.
Read More+
