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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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).
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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.
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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.
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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.
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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.
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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
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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.
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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.
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Survey assessing the Member States’ rules on health data in the light of GDPR
23rd June 2020Request for comments from EMA.
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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.
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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
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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.
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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.
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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.
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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.
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Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #3
3rd June 2020As part of its coordinated response to the pandemic, the International Coalition of Medicines Regulatory Authorities (ICMRA) convened its regular high-level meeting of regulators from around the world on 27 May 2020 to discuss COVID-19 policies, regulatory aspects of COVID-19 medicine development and pragmatic approaches to address challenges posed by the ongoing pandemic.
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MHRA issues a scientific opinion for the first medicine to treat COVID-19 in the UK
3rd June 2020MHRA has today given the first positive scientific opinion under the Early Access to Medicines Scheme (EAMS) for use of Gilead’s remdesivir.
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 May 2020
3rd June 2020Eight new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its May 2020 meeting.
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Good Laboratories Practice Symposium 2020
1st 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.
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DRAFT DOCUMENT FOR COMMENTS: GMP water for pharmaceutical use
27th May 2020Open for comments, deadline 30th June 2020.
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Coronavirus (COVID-19): new dedicated Yellow Card reporting site for medicines and medical devices
26th May 2020Reporting to the new site will enable the MHRA to rapidly identify new and emerging side effects and medical device incidents in COVID-19 treatment, including side effects for medicines taken by patients to manage long-term or pre-existing conditions.
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EMA clarifies Computer Validation and Data Integrity responsibilities in Clinical Trials
19th May 2020The European Medicines Agency (EMA) has published a notice for sponsors of clinical trials (CTs) to highlight the requirements for the qualification and validation of computer systems used for managing CT data. This is based on recent inspection findings and takes into account implications on the integrity, reliability, robustness and acceptability of data. In line with this notice, the EMA has also updated questions 8 and 9 on EMA´s GCP Q&A website, which provide further guidance on computerised systems.
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Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #2
19th May 2020The International Coalition of Medicines Regulatory Authorities (ICMRA) convened a virtual meeting of regulators from around the world on 14 May 2020 to discuss high-level policy issues and regulatory requirements to respond to the ongoing COVID-19 pandemic. The strategic meeting underlined the need and commitment by global regulators to cooperate and align their approaches to clinical trial management, medicine supply issues and pharmacovigilance in light of the medical emergency presented by COVID-19.
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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 May 2020
19th May 2020PRAC concludes review of new information on the known risk of breast cancer with hormone replacement therapy
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OECD SERIES ON PRINCIPLES OF GOOD LABORATORY PRACTICE AND COMPLIANCE MONITORING
19th May 2020Number 21 OECD Position Paper Regarding Possible Influence of Sponsors on Conclusions of GLP Studies
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MHRA: How to manage temporary GDP process changes and risks through the COVID-19 pandemic
14th May 2020Terry Madigan, 13th May During the Covid-19 pandemic you may need to adjust how you operate, for example using temporary process deviations and temporary staff. Such changes should be documented either as deviations, change controls or similar and incorporate quality risk management principles as described in the EU Guidelines on Good Distribution Practice for finished products.
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MHRA: Patient Support Programmes
14th May 2020Kiernan Trevett, Posted on:7 May 2020 - Many marketing authorisation holders (MAHs) sponsor and run a wide variety of programmes that are often internally termed a ‘patient support programme’ (PSP) and we are often asked by industry about the expectations for the collection of safety data from these programmes.
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MHRA: Using personal data in your business or other organisation during and after the transition period
14th May 2020What you should do when transferring people’s personal data between the UK and the EU/EEA.
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Safety Observer - COVID-19 Update Now Available
14th May 2020Clinical Safety & Pharmacovigilance Regulatory Intelligence Review
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MHRA: How tests and testing kits for coronavirus (COVID-19) work
13th May 2020The MHRA has released information for members of the public, patients, professionals and industry about COVID-19 tests and testing kits....
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COVID-19: how EMA fast-tracks development support and approval of medicines and vaccines
5th May 2020As researchers race to develop vaccines and therapeutics against COVID-19, EMA has published an overview of how the Agency will accelerate its regulatory procedures so that marketing authorisations of safe, effective and high-quality COVID-19 related medicines can be granted as soon as possible.
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Good Pharmacovigilance Practice Symposium 2020
5th May 2020The Good Pharmacovigilance Practice (GPvP) Symposium 2020, held on 11 February in London and attended by 380 delegates, launched the weeklong series of events led by the Inspectorate as part of the MHRA Good Practice Symposia week.
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Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 21-23 April 2020
1st May 2020CVMP adopts concept paper on environmental risk assessment for parasiticide veterinary medicinal products used in companion animals CVMP opinions on veterinary medicinal products
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Notice to sponsors on validation and qualification of computerised systems used in clinical trials
1st May 2020Note: This notice should be read in conjunction with Q8 and Q9 from the good clinical practice (GCP) Q&As published on the EMA website: https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-clinicalpractice/qa-good-clinical-practice-gcp
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Coronavirus: EC issues guidance to mitigate clinical trial disruption
28th April 2020Today, the European Commission has published guidance to ensure that clinical trials can continue taking place in the EU during the COVID-19 pandemic.....
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Delayed implementation of MDR
27th April 2020The European Parliament and Council have approved a proposal to delay the full implementation of the Medical Device Regulation 2017/745 (MDR) for one year to 26 May 2021. This means that the full applicability of the MDR will fall outside of the transition period agreed with the EU.
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MRC Regulatory Support Centre COVID-19 Bulletin
27th April 2020The COVID-19 pandemic has significantly impacted health research as it has every aspect of our lives. In this bulletin we pull together information about the special research governance arrangements currently in place to help tackle the pandemic. Many of these arrangements will be temporary.
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Exceptional GMP flexibilities for medicines manufacturers during the coronavirus (COVID-19) outbreak
22nd April 2020These temporary good manufacturing practice (GMP) flexibilities will be allowed to address the current exceptional circumstances
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EMA - Update to guidance on regulatory expectations in the context of COVID-19 pandemic
20th April 2020The European Commission, EMA and the national competent authorities have agreed a series of measures to mitigate the impact of disruptions caused by COVID-19 on the conduct of inspections of manufacturing facilities or other sites relevant for medicinal products in the European Union.
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Pharmacovigilance Inspection Metrics April 2018 to March 2019
20th April 2020The MHRA GPvP inspectorate recently published their latest inspection metrics for the period from April 2018 to March 2019. The full metrics report is available on GOV.UK.
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MedDRA Version 23.0 Update to be Produced
15th April 2020The ICH MedDRA Management Committee has decided to provide the new COVID-19 terms within the MedDRA dictionary in a very expedited fashion, given the current very exceptional time with the COVID-19 pandemic demanding flexible approaches to ensure that any scientific and medical information from the COVID-19 outbreak can be captured, shared and analysed appropriately.
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Guidance on regulatory requirements in the context of the COVID-19 pandemic
14th April 2020The European Commission, EMA and the European medicines regulatory network have developed a question-and-answer (Q&A) document to provide guidance to stakeholders on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic, with a particular focus on crucial medicines for use in COVID-19 patients.
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MHRA New opportunities to submitting your proposals for test kits, even when your proposals don't meet our specifications.
14th April 2020Guidance on coronavirus (COVID-19) tests and testing kits - updated with new opportunities to submitting your proposals for test kits, even when your proposals don't meet our specifications.
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Approval of GxP documents when working from home during the coronavirus (COVID-19) outbreak
10th April 2020Guidance for organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA, covering the approval of paper documents when working from home
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CVMP Draft Reflection paper on promoting the authorisation of alternatives to antimicrobials in the EU
10th April 2020Deadline for comments 30th April 2020
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Pharmaceutical and diagnostics industries are already responding to Governments call to arms
9th April 2020We can first ensure that testing is available for patients who need it, then expand testing of critical NHS staff and their families, followed by testing critical key workers, and then the community as a whole. The plan includes a national effort for diagnostics, to build mass testing capacity at a totally new scale. We did not start this crisis with a large diagnostics industry, so instead we are going to have to build one.
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Conduct of remote Investigator Site Audits (ISAs) - Guidance
8th April 2020TMQA have produced this document on the conduct of remote ISAs.
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MHRA - Flexibility in GxP Labs
8th April 2020Guidance for manufacturers and Good Practice (GxP) laboratories on exceptional flexibilities for maintenance and calibration during the coronavirus COVID-19 outbreak
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Process Licensing Update
3rd April 2020A blog post by Asif Janjua, Posted on:3 April 2020, to give an update on a change to how the MHRA are issuing their licences and certificates due to the coronavirus pandemic; and a reminder to keep your contact details up to date.
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EMA Regulatory Science to 2025
1st April 2020EMA has published its Regulatory Science Strategy to 2025 today. The strategy provides a plan for advancing regulatory science over the next five years, covering both human and veterinary medicines. It comes in response to the dramatic acceleration of the pace of innovation in recent years and the need for regulators to be ready to support the development of increasingly complex human and veterinary medicines that combine different technologies. The ongoing COVID-19 pandemic underlines the need for rapid and close engagement of all stakeholders and partners involved in the development and supervision of medicines in the European Union and globally, which is one of the fundamental principles of this strategy. The learnings from the handling of this public health crisis will be incorporated so that we can adapt our process in real-time, where needed. The strategy sets out key areas where new or enhanced engagement of the European medicines regulatory network is essential and where advances in regulatory science are necessary. The document identifies strategic goals for such engagement for human and veterinary medicines and proposes core recommendations and underlying actions to support these.
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Advice for Good Laboratory Practice facilities in relation to coronavirus (COVID-19)
31st March 2020MHRA Blog Entry: It is recognised that there are potential challenges specific to GLP facilities and studies at this time. The aim of this post is to provide you with information that will enable a flexible but compliant approach during this period.
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Health Research Authority (NHS) - News
31st March 2020Important updates about health research during the COVID-19 pandemic.
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Links from COVID-19 Webinar held on 31st March 2020
31st March 2020Please find the links from the recent webinar on COVID-19, held at 1pm (BST) on 31st March 2020.
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Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic
30th March 2020Key changes from v1 (20-03-2020): additional clarification on obtaining informed consent; link to methodological guidance on statistical considerations in relation to COVID-19 pandemic; advice on IMP stocks, safety reporting, conduct of audits; temporary halts
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New advice to support mental health during coronavirus outbreak
30th March 2020People struggling with their mental health during the coronavirus (COVID-19) outbreak will be offered additional online support and practical guidance to help them cope. RQA have also produced an infographic here to provide some tips.
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Points to consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials
30th March 2020Due to the urgency, this guidance is issued with a 4-week public consultation. It should be noted that due to the rapidly evolving situation further updates to this guidance are possible and likely.
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Covid-19: FDA Postpones Domestic and Foreign Inspections
26th March 2020In response to the COVID-19 outbreak, the U.S. Food and Drug Administration FDA has decided to postpone most foreign inspections until the end of April.
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EU GMP Annex 21 published
26th March 2020On 20 March, after some delays, the new Annex 21 to the EU-GMP Guidelines was published as a draft. The document is entitled 'Importation of medicinal Products'. Consultation phase is 20 March 2020 to 20 June 2020. The deadline for coming into operation still needs to be determined.
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COVID-19 - MHRA
25th March 2020The MHRA have put a lot of links on about inspections during these unprecedented times, here is the latest. We have also put together a COVID-19 Discussion Forum so everyone can discuss and share information related to working during this time.
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MHRA guidance on Coronavirus (COVID-19)
25th March 2020The MHRA are producing guidance for industry covering the Coronavirus (COVID-19) outbreak. Quite a few updates today.
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Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic
25th March 2020This guidance provides recommendations to industry regarding post marketing adverse event reporting for drugs, biologics, medical devices, combination products,2 and dietary supplements during a pandemic.
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Turning pharma green: an eco-wish list for the industry
25th March 2020An interesting article: The reality of climate change is hard to ignore. As one of the biggest polluters, and simultaneously the industry tasked with trying to tackle the global health outcomes of environmental degradation, pharma has a responsibility to be more eco-friendly. Allie Nawrat compiles an eco-wish list of how this global industry can make its activities more sustainable.
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Addressing the potential impact of novel coronavirus disease (COVID-19) on medicines supply in the EU
18th March 2020The EU (EMA, the European Commission and national competent authorities in the Member States) have organised the first meeting of the EU Executive Steering Group on shortages of medicines caused by major events to discuss measures aimed at addressing the impact of the outbreak of COVID-19 on the supply of medicines in the EU.
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Annual overview of the involvement of patients and healthcare professionals in the work of the EMA
17th March 2020Public engagement highlights - Annual overview of the involvement of patients and healthcare professionals in the work of the European Medicines Agency (EMA)
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NIH clinical trial of investigational vaccine for COVID-19 begins
16th March 2020A Phase 1 clinical trial evaluating an investigational vaccine designed to protect against coronavirus disease 2019 (COVID-19) has begun at Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is funding the trial. KPWHRI is part of NIAID’s Infectious Diseases Clinical Research Consortium. The open-label trial will enroll 45 healthy adult volunteers ages 18 to 55 years over approximately 6 weeks. The first participant received the investigational vaccine today.
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MHRA Advice for Management of Clinical trials in relation to Coronavirus
12th March 2020MHRA are aware that there are challenges arising in relation to Coronavirus and the effect this is having on the conduct of clinical trials....
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ICH Q12 Technical and regulatory considerations for pharmaceutical product lifecycle management
11th March 2020Current version adopted 4th March 2020.
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MHRA Blog Post: GCP Inspections: Expectations and the dos and don’ts for hosting
11th March 2020GCP Inspections: Expectations and the dos and don’ts for hosting
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Call for a MRA on GMP in the Context of Ambitious and Comprehensive EU-UK Future Relationship Negotiations
4th March 2020Three European Industry Associations (EFPIA, Medicines for Europe and AESGP) have published 'Call for a Mutual Recognition Agreement on Good Manufacturing Practice (GMP) in the Context of Ambitious and Comprehensive EU-UK Future Relationship Negotiations'.
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New MHRA Blog Post: Remote working and QP certification
26th February 2020In the modern world it is increasingly common to see flexible, part-time or home working arrangements. Digital connections can allow us to continue to work effectively when we are away from the office. The pharmaceutical industry is no exception, and with some companies employing a part-time or contract Qualified Person (QP), it is no surprise that the QP continues to play a key role even when away from the site.
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Second targeted stakeholders' consultation on the revision of Annex 1, on manufacturing of sterile medicinal products, of Eudralex volume 4
20th February 2020Period of consultation From 20 February 2020 to 20 May 2020. Objective of the consultation Annex 1 was first published in 1971, to ensure sterility of medicinal products placed on the market for the benefits of patients. Since then it has undergone a number of targeted updates but, until now it has not undergone a full review. This revision is intended to add clarity, introduce the principles of Quality Risk Management to allow for the inclusion of new technologies and innovative processes and to change the structure to a more logical flow.
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EMA - How does EMA support SMEs?
12th February 2020A new video on how the EMA supports small and medium enterprises.
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EMA Consultation - Reflection Paper on GMP and MAHs
12th February 2020The European Medicines Agency has released for public consultation the reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders.
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GMDP Symposium, Nov 2019
12th February 2020The MHRA GMDP Symposium took place on 11 to 14 November 2019 in London and 26 to 27 November 2019 in Glasgow. There will also be a write up in Quasar 151 (April 2020) from the GMP Committee.
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MHRA Guidance Update: Notified bodies for medical devices
5th February 2020MHRA Guidance Update: Notified bodies for medical devices
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Meeting highlights CHMP, Jan 2020
5th February 2020Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 January 2020
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UK withdrawal from the EU on 31 January 2020
31st January 2020The United Kingdom will formally leave the European Union on 31 January 2020 and will become a third country to the EU. On 1 February 2020 a transition period will start which is due to end on 31 December 2020.
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Pilot programme for international cooperation in GMP inspection of manufacturers of sterile medicinal products for human use
22nd January 2020Pilot programme for international cooperation in GMP inspection of manufacturers of sterile medicinal products for human use. The purpose of the document is to set out the terms of reference, including objectives, scope, requirements and general principles of an international inspection pilot programme covering manufacturers of sterile medicinal products.
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HMA-EMA Joint Big Data Taskforce Updates
21st January 2020The HMA and EMA have released more information from their joint 'Big Data Task Force'.
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MHRA Inspector Recruitment
17th January 2020The MHRA have produced a blog to give you the information you need to consider if applying for future roles.
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