If you are aware of any news items that would be of interest to the RQA membership, please contact the RQA office.
Open for comments, deadline 30th June 2020.
Reporting 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.
The 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.
The 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.
PRAC concludes review of new information on the known risk of breast cancer with hormone replacement therapy
Number 21 OECD Position Paper Regarding Possible Influence of Sponsors on Conclusions of GLP Studies
Terry 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.
Kiernan 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.
What you should do when transferring people’s personal data between the UK and the EU/EEA.
Clinical Safety & Pharmacovigilance Regulatory Intelligence Review
The MHRA has released information for members of the public, patients, professionals and industry about COVID-19 tests and testing kits....
As 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.
The 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.
CVMP adopts concept paper on environmental risk assessment for parasiticide veterinary medicinal products used in companion animals CVMP opinions on veterinary medicinal products
Note: 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
Today, the European Commission has published guidance to ensure that clinical trials can continue taking place in the EU during the COVID-19 pandemic.....
The 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.
The 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.
These temporary good manufacturing practice (GMP) flexibilities will be allowed to address the current exceptional circumstances
The 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.
The 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.
The 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.
The 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.
Guidance 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.
Guidance 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
Deadline for comments 30th April 2020
We 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.
TMQA have produced this document on the conduct of remote ISAs.
Guidance for manufacturers and Good Practice (GxP) laboratories on exceptional flexibilities for maintenance and calibration during the coronavirus COVID-19 outbreak
A 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.
EMA 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.
MHRA 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.
Important updates about health research during the COVID-19 pandemic.
Please find the links from the recent webinar on COVID-19, held at 1pm (BST) on 31st March 2020.
Key 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
People 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.
Due 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.
In 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.
On 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.
The 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.
The MHRA are producing guidance for industry covering the Coronavirus (COVID-19) outbreak. Quite a few updates today.
This 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.
An 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.
The 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.
Public engagement highlights - Annual overview of the involvement of patients and healthcare professionals in the work of the European Medicines Agency (EMA)
A 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.
MHRA are aware that there are challenges arising in relation to Coronavirus and the effect this is having on the conduct of clinical trials....
Current version adopted 4th March 2020.
GCP Inspections: Expectations and the dos and don’ts for hosting
Three 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'.
In 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.
Period 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.
A new video on how the EMA supports small and medium enterprises.
The European Medicines Agency has released for public consultation the reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders.
The 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.
MHRA Guidance Update: Notified bodies for medical devices
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 January 2020
The 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.
Pilot 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.
The HMA and EMA have released more information from their joint 'Big Data Task Force'.
The MHRA have produced a blog to give you the information you need to consider if applying for future roles.
The 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.
The EMA's Management Board met in December for their 106th meeting.
The 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.
European GDP Association launches newly designed website
We 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.
The European Medicines Agency has released for public consultation the concept paper for the revision of scientific guidelines on limited market for veterinary medicinal products.