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 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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2019 Risk Management Standard for Medical Devices ISO 14971:2019
8th January 2020The currently valid ISO 14971 of 2007 will now be replaced by the version from 2019 (revision 3). The standard is applicable to all phases of a medical device´s life cycle.
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EMA Management Board: December Meeting Highlights
3rd January 2020The EMA's Management Board met in December for their 106th meeting.
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MHRA GCP Non-Commercial Symposium 2019
23rd December 2019The annual GCP Symposium was held by the MHRA on 11 September 2019 in Manchester. There was a change of format as a result of feedback received at previous events therefore this year the symposium was smaller and focused on non-commercial organisations (Trusts/Health Boards/University sponsors, Charities and investigator sites). The event was popular with approximately 250 delegates attending.
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European GDP Association launches new website
18th December 2019European GDP Association launches newly designed website
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EMA Awareness session for Animal Health - Call for Interest
10th December 2019We would like to inform you that the call for express of interest to participate in the European Medicines Agency (EMA) third Awareness Session, focused on science and regulation for animal health and welfare is now open. The session will be held at the EMA in Amsterdam, on Thursday 2 and Friday 3 April 2020.
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EMA Concept paper for the revision of scientific guidelines on limited market for veterinary medicinal products.
10th December 2019The European Medicines Agency has released for public consultation the concept paper for the revision of scientific guidelines on limited market for veterinary medicinal products.
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Digital Health and Pharma 4.0 - Mark Birse
7th November 2019Digital Health and Pharma 4.0, Mark Birse. MHRA Blog.
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Official Statistics - GMP Inspection deficiencies 2018
7th November 2019Good manufacturing practice inspection deficiencies - Added MHRA GDP Inspection Deficiency Data 2018.
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Pharmacovigilance Risk Assessment Committee (PRAC)
7th November 2019Meeting Highlights
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Chinese Authorities visit EMA to discuss GCP and GMP
29th October 2019The Deputy Commissioner of the Chinese National Medical Product Administration (NMPA), Dr Chen Shifei, visited EMA on 25 October together with a delegation.
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EMA Management Board
9th October 2019Highlights of October 2019 meeting
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MHRA Process Licensing: useful information
9th October 2019New MHRA Blog post.
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No-deal Brexit - update to GCP, PV and GMP/GDP
9th October 2019A line was added to the GCP, PV and GMP/GDP pages, risk-based inspection programmes will remain unchanged
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Webinars: preparing to make submissions to the MHRA after Brexit
9th October 2019Webinars for pharmaceutical companies, clinical trial sponsors, e-cigarette producers and brokers of medicinal products about new MHRA systems you’ll need to use if there’s a no-deal Brexit.
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ICH Good Clinical Practice Guidelines (ICH E6) - Open Comment Opportunity - Deadline: 18 October 2019
7th October 2019As a follow-up to the survey on the renovation of the ICH Good Clinical Practice Guidelines (ICH E6) conducted in August, the Clinical Trials Transformation Initiative (CTTI) has launched a new open comment opportunity which enables specific comments to be collected. Findings will be provided to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) for their consideration. Professionals involved in research for regulatory purposes are invited to provide comments as an individual or an organisation. Please complete the survey (only available in English) by 18 October 2019 using the following link: https://duke.qualtrics.com/jfe/form/SV_a2XzYMfecEgIjsx Please note that this activity is not anonymous, your name and affiliation, together with your comments, will be linked and provided to ICH. You have received this mail because you have registered in the EMA stakeholders database and subscribed to receive this kind of information. However, if you no longer wish to receive such communications from us, please send an email to StakeholdersDB@ema.europa.eu to unsubscribe. We would be grateful if you could disseminate this email to anyone else who might be interested in this information. With kind regards, Nathalie Macle Public Engagement Department Stakeholders and Communication Department stakeholdersDB@ema.europa.eu | www.ema.europa.euAs a follow-up to the survey on the renovation of the ICH Good Clinical Practice Guidelines (ICH E6) conducted in August, the Clinical Trials Transformation Initiative (CTTI) has launched a new open comment opportunity which enables specific comments to be collected. Findings will be provided to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) for their consideration. Professionals involved in research for regulatory purposes are invited to provide comments as an individual or an organisation. Please complete the survey (only available in English) by 18 October 2019 using the following link: https://duke.qualtrics.com/jfe/form/SV_a2XzYMfecEgIjsx Please note that this activity is not anonymous, your name and affiliation, together with your comments, will be linked and provided to ICH.
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