If you are aware of any news items that would be of interest to the RQA membership, please contact the RQA office.
Highlights of October 2019 meeting
New MHRA Blog post.
A line was added to the GCP, PV and GMP/GDP pages, risk-based inspection programmes will remain unchanged
Webinars 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.
As 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.
MHRA 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.
The 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".
A 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.
EMA 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.
Updated 24th September 2019.
On 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."
Today the Medicines and Healthcare products Regulatory Agency (MHRA) welcomes Dr June Raine as its interim Chief Executive.
The MHRA have updated their advice in the event of a no-deal Brexit. This update relates to the UK Responsible Person section.
Includes agenda and Sept 2019 PRAC statistics
The MHRA have updated their guidelines on how you can continue to submit regulatory and notification information to the UK.
Regulators 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.
The 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.
EMA/FDA analysis shows high degree of alignment in marketing application decisions between EU and US.
The 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).
MHRA Blog post by Tracy Moore, 8th August.
Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal - Updated 8 August 2019
Dr 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.
Detailed guidance on advertising and promoting medicines - updated 12th August 2019.
The first edition of the EMA's 'What’s new in Pharmacovigilance? QPPV UPDATE' is available.
New 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).
BP and USP MoU formalise partnership to strengthen quality of medicines and public health
The 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).
Supporting medicine developers in generating quality data packages in early access approaches (PRIME and breakthrough therapies): workshop report published
The 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.
The Human Medicines and Medical Devices (Amendment etc.) (EU exit) Regulations 2019 was laid in UK parliament on the 24th July 2019.
The EMA recently shared the highlights of patient, consumer, healthcare professional and academia involvement in our activities in 2018 with the RQA.
Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 16-18 July 2019
EMA 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.
The 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.
With 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.....
Updated Version of the Clinical Trials Regulation Questions & Answers Paper
Today, the U.S. Food and Drug Administration (FDA) issued a final guidance for industry entitled Risk Evaluation and Mitigation Strategies: Modifications and Revisions.
The 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.
The 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.
MHRA's GCP Serious Breaches metrics and examples have been released.
WHO Document for Consultation GOOD STORAGE AND DISTRIBUTION PRACTICES
Minutes and presentations now available.