If you are aware of any news items that would be of interest to the RQA membership, please contact the RQA office.
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.
Digital Health and Pharma 4.0, Mark Birse. MHRA Blog.
Good manufacturing practice inspection deficiencies - Added MHRA GDP Inspection Deficiency Data 2018.
The Deputy Commissioner of the Chinese National Medical Product Administration (NMPA), Dr Chen Shifei, visited EMA on 25 October together with a delegation.
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).