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 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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MHRA Christmas 2019 Notifications
1st October 2019MHRA have updated the Christmas 2019 notice period. Manufacturers are advised that MHRA will not be accepting notifications for clinical investigation or study amendments during the period 14 December 2019 – 1 January 2020 (inclusive). Any notifications received during this period will be processed in the new year and the 60 day assessment periods will start from 3 January 2020 for valid clinical investigation notifications. Any notifications received before 14 December 2019 will be processed as normal and there will be no interruption to the 60 day process over the Christmas period for these notifications.
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MHRA Brexit Update: GPvP
27th September 2019The MHRA have released a guidance note entitled "Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK marketing authorisation holders".
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Focused stakeholders consultation on revised draft PIC/S GMP Guide Annex 2A and Annex 2B
26th September 2019A draft revision of the PIC/S GMP Guide Annex 2 (Manufacture of biological medicinal substances and products for human use) has been prepared by the PIC/S Working Group on revision of Annex 2 established with WHO, led by Francesco Cicirello, Australia / TGA, and by the PIC/S Sub-Committee on GMDP Harmonisation, led by Paul Gustafson, Health Canada.
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EMA’s work on new veterinary regulation advances
25th September 2019EMA has launched a new webpage that shows the progress made by the Agency in the implementation of the new Veterinary Medicines Regulation (Regulation (EU) 2019/6), which becomes applicable on 28 January 2022.
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MHRA Register of Written Confirmations For UK Active Substance Manufacturers
25th September 2019Updated 24th September 2019.
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Fda Issues Guidance for Industry on Wholesale Distributor Verification Requirement for Saleable Returned Drug Product
24th September 2019On the 23rd September, FDA announced the availability of a final guidance for industry entitled "Wholesale Distributor Verification Requirement for Saleable Returned Drug Product--Compliance Policy."
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Dr June Raine has become interim Chief Executive of the MHRA
23rd September 2019Today the Medicines and Healthcare products Regulatory Agency (MHRA) welcomes Dr June Raine as its interim Chief Executive.
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MHRA Update to a No-Deal Brexit - Medical Devices
19th September 2019The MHRA have updated their advice in the event of a no-deal Brexit. This update relates to the UK Responsible Person section.
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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC)
11th September 2019Includes agenda and Sept 2019 PRAC statistics
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MHRA: Brexit No-Deal Update
9th September 2019The MHRA have updated their guidelines on how you can continue to submit regulatory and notification information to the UK.
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EMA publishes first two Guidances on Drug Shortages
4th September 2019Regulators in the European Union have taken first steps to diminish shortages of medicinal products. The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) published two guidance documents which can be seen as foundation or first step for a long way: how to define and how to communicate drug shortages.
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Global public meeting on draft ICH guideline on clinical trials
4th September 2019The global guidance for the conduct of clinical trials is currently undergoing a major revision. As part of the worldwide consultation process, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is organising a public meeting to review its draft E8 (R1) Guideline ‘General Considerations for Clinical Trials’. EMA is encouraging its stakeholders to register for this meeting, which will be held on 31 October 2019 at the United States Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland, United States of America. Participants will be able to attend in person or via webcast.
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EMA/FDA analysis - Alignment of Decisions
21st August 2019EMA/FDA analysis shows high degree of alignment in marketing application decisions between EU and US.
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Questions and Answers on Current GMP—Laboratory Controls
21st August 2019The FDA has recently added three new questions to its Q&A section on cGMP in the Quality Control Laboratory (chromatography systems and describe FDA's perception of basic cGMP principles in chromatographic procedures).
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Falsified Medicines and the supply chain
13th August 2019MHRA Blog post by Tracy Moore, 8th August.
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MHRA Update to regulations if there is a no deal Brexit
13th August 2019Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal - Updated 8 August 2019
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Protecting Public Health - Article
13th August 2019Dr Ian Hudson, CEO, Medicines and Healthcare products Regulatory Agency (MHRA) spoke with Viveka Roychowdhury on how the Agency is working with pharmaceutical companies to increase compliance with Good Manufacturing Practices (GMP) as well as preparing for Brexit and beyond. Read the full article.
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Updated - Blue Guide: advertising and promoting medicines
13th August 2019Detailed guidance on advertising and promoting medicines - updated 12th August 2019.
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EMA Update - What’s new in Pharmacovigilance?
12th August 2019The first edition of the EMA's 'What’s new in Pharmacovigilance? QPPV UPDATE' is available.
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Electronic Health Records
7th August 2019New MHRA Blog Post on eHRs: as you will be aware, in the UK there is a national NHS initiative to replace patients’ paper medical records with electronic health records (EHRs). Although a national initiative, trusts are implementing this locally with different service providers. At several trusts this consists of scanning all written records into the EHR and destroying original source documents (both historic records and current visits).
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BP and USP MoU formalise partnership
31st July 2019BP and USP MoU formalise partnership to strengthen quality of medicines and public health
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EMA publishes Draft on Quality Requirements for Combination Products
31st July 2019The European Medicines Agency (EMA) has published a draft guideline on quality requirements for combinations of medicinal products and medical devices (so-called Drug Device Combinations - DDCs).
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Supporting medicine developers in generating quality data packages
31st July 2019Supporting medicine developers in generating quality data packages in early access approaches (PRIME and breakthrough therapies): workshop report published
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OECD Update to the Principles of GLP
29th July 2019The OECD recently released document 20 in the GLP series: Guidance Document for Receiving Authorities on the Review of the GLP Status of Non-Clinical Safety Studies.
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MHRA Update on a No Deal Brexit
26th July 2019The Human Medicines and Medical Devices (Amendment etc.) (EU exit) Regulations 2019 was laid in UK parliament on the 24th July 2019.
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EMA Public Engagement Highlights of 2018
25th July 2019The EMA recently shared the highlights of patient, consumer, healthcare professional and academia involvement in our activities in 2018 with the RQA.
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CVMP meeting, 16-18 July 2019
24th July 2019Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 16-18 July 2019
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EMA takes note of the European Ombudsman’s decision on pre-submission activities
24th July 2019EMA welcomes the European Ombudsman’s recognition of the value and need for scientific advice and her recommendations are in line with EMA’s ongoing initiatives to further increase transparency.
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Government to invest £16m in ‘life-saving’ medical advances
24th July 2019The Government has announced the decision to invest around £16 million in various ‘life-saving’ medical advances, including improved diagnosis and treatment for cancer and heart disease.
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EU and US reach a milestone....
15th July 2019With the recognition by the US Food and Drug Administration (FDA) of Slovakia, the European Union and the United States have now fully implemented the mutual recognition agreement (MRA) for inspections of manufacturing sites for certain human medicines in their respective territories.....
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Updated Version of the Clinical Trials Regulation Questions & Answers Paper
11th July 2019Updated Version of the Clinical Trials Regulation Questions & Answers Paper
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GPvP - FDA issues final guidance for Industry on Risk Evaluation and Mitigation Strategies: Modifications and Revisions
10th July 2019Today, the U.S. Food and Drug Administration (FDA) issued a final guidance for industry entitled Risk Evaluation and Mitigation Strategies: Modifications and Revisions.
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European Commission - Withdrawal of the UK and EU rules in the field of GLP
1st July 2019The United Kingdom submitted on 29 March 2017 the notification of its intention to withdraw from the Union pursuant to Article 50 of the Treaty on European Union.
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MHRA public consultation on its plans to apply analytical quality by design (AQbD) principles to its Pharmacopoeia
12th June 2019The MHRA opened a three-month public consultation (until August 31, 2019) on its plans to apply analytical quality by design (AQbD) principles to its pharmacopoeia.
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MHRA - GCP Serious Breaches - the 2018 Edition
3rd June 2019MHRA's GCP Serious Breaches metrics and examples have been released.
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GOOD STORAGE AND DISTRIBUTION PRACTICES
29th May 2019WHO Document for Consultation GOOD STORAGE AND DISTRIBUTION PRACTICES
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MHRA STEM Minutes
29th May 2019Minutes and presentations now available.
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