Company News We’re delighted to announce that Nicole and Shona will be taking part in the RQA Virtual Symposia next week. Held on 8th and 9th September, the event will feature two dedicated virtual symposia focused on QA Careers and QA Leadership. Regulatory News EMA Publishes PRAC [...]
Company News We’re delighted to be exhibiting at the Research Quality Association (RQA) 8th Global QA Conference 2026 in London from 4th to 6th November! If you're attending, be sure to stop by and say hello to our team, who will be available throughout the event to [...]
Regulatory Updates EMA Launches Initiatives to Strengthen Medicines Development for Women’s Health On 2nd July, the EMA announced new initiatives to address gaps and challenges in women’s health and support the development of medicines that better reflect women’s needs. The activities will focus on improving evidence generation, representation [...]
Company News We’re delighted to be exhibiting at the Bionow Neuroscience Conference in Sheffield next week! If you’re attending, come and say hello. Stacey will be on hand to discuss how Tower Mains can support you. Regulatory Updates EMA and African Regulatory Authorities Strengthen Collaboration on Ebola Response [...]
Company News We were delighted to be well represented at the Research Quality Association (RQA) 2026 International QA Virtual Conference last month. Nicole Ainsworth, Stacey Harding, Rosemary Ichaba, and Anna Lothian all contributed to the programme, covering topics including veterinary GCP, audit challenges in GxP environments, and environmental [...]
Company News ICH GCP E6 (R3) has officially come into effect in the UK, bringing a stronger focus on risk-based approaches, data integrity, and modern trial delivery. These changes will shape how clinical trials are designed, managed, and inspected. To help organisations understand the practical impact, we’ve launched [...]
Company News We're delighted to be exhibiting at the 42nd Society of Quality Assurance Annual Meeting in National Harbor, Washington DC this month! Bringing together over 800 QA professionals from around the world, the meeting will explore key hot topics including GCP, GLP, GMP, pharmacovigilance, scientific archiving, computer [...]
Regulatory News FDA Launches PreCheck Pilot to Strengthen US Pharmaceutical Manufacturing On 1st February, the FDA launched the PreCheck pilot program, designed to strengthen the domestic pharmaceutical supply chain by providing earlier regulatory engagement and streamlined assessments for new US manufacturing facilities. The initiative aims to encourage domestic [...]
Regulatory News EMA and FDA Set Common Principles for AI Use in Medicine Development On 14th January, the European Medicines Agency (EMA) and the FDA jointly issued a set of ten guiding principles for the responsible use of artificial intelligence (AI) in drug development. These principles provide broad guidance [...]
Celebrating 25 Years of Quality, Continuity and Trust This year marks a major milestone for Tower Mains as we celebrate 25 years of supporting the global scientific community. From the outset, our approach has been shaped by what customers told us mattered most: access to trusted, end-to-end quality [...]
Company News Begin your GxP Journey with Our Essentials Course Whether you're entering a GxP-regulated environment for the first time or just interested to know a bit about what is out there, GxP Essentials equips you with the foundations you need to work confidently, competently, and compliantly. In [...]
Company News RQA 2025 International QA Conference We had a brilliant couple of days in Belfast for the Research Quality Association (RQA) 2025 International QA Conference! From inspiring talks and lively discussions to reconnecting with friends and meeting new faces, the conference was full of energy, insight, and [...]
Regulatory News EU Consultation Launched to Update GMP Chapter 1 on Pharmaceutical Quality Systems On 3rd September, the European Commission opened a stakeholders’ consultation on proposed revisions to Chapter 1 of EudraLex Volume 4, Good Manufacturing Practice (GMP) guidelines – the section covering the Pharmaceutical Quality System. The draft updates [...]
Company News We’re gearing up for two key industry events this autumn! First, we’ll be exhibiting at BioCap 2025, hosted by Bionow on Thursday, 25th September. It’s a fantastic opportunity to reconnect with familiar faces, meet new contacts, and gain insights from industry leaders on the latest trends and [...]
Regulatory News UK Government to Align with EU Standards for High-Risk In Vitro Diagnostic Devices On 10th July, the UK government announced plans to amend the Medical Devices Regulations 2002 for Great Britain by adopting the EU Common Specifications for high-risk in vitro diagnostic (IVD) devices and repealing [...]
Company News Ready to plan ahead? Whether you're looking at Q3 or Q4, we’d love to help. As we approach the midpoint of the year, now’s the ideal time to get strategic about your audit schedule. While Q3 remains a great time to spread the load and avoid [...]
Company News 12th Annual Outsourcing in Clinical Trials UK & Ireland We’re thrilled to announce that Tower Mains will be exhibiting at the 12th Annual Outsourcing in Clinical Trials UK & Ireland in London next week! If you're attending, be sure to stop by and say hello - [...]
Company News RQA European QA Virtual Conference We are thrilled to announce that our Head of Quality Assurance, Shona Ross, and two of our Senior Associates, Anna Lothian and Nicole Ainsworth will be participating in the upcoming 2025 RQA European QA Virtual Conference on the 20th-22nd May. For [...]
Company News We are thrilled to announce that our Head of Quality Assurance, Shona Ross, and Head of Operations, Lianne Roeling, will be heading to Orlando, Florida for the upcoming Society of Quality Assurance 41st Annual Meeting. Shona will also be leading a quick session on Wednesday morning [...]
Company News We are thrilled to announce that our Head of Quality Assurance, Shona Ross, and Head of Operations, Lianne Roeling, will be heading to Orlando, Florida for the upcoming Society of Quality Assurance 41st Annual Meeting! Stay tuned for more updates in the coming weeks. Regulatory [...]
Company News 2024 was a year of growth for Tower Mains, with our team expanding to 14 and the addition of a new Associate strengthening our Investigator Site Auditing services. We also enhanced our training offerings and deepened our engagement with industry and academia to support quality understanding [...]
Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates. Company Updates Merry Christmas and a Happy New Year from all of us! As we wrap up our final newsletter of 2024, we want to take a moment to thank you for your continued support [...]
Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates. Company Updates We're moving to monthly! As of 2025, our weekly newsletter will be going monthly. This change will allow us to deliver more comprehensive coverage of industry news, regulatory updates, and key developments, with [...]
Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates. Company Updates We're moving to monthly! As of 2025, our weekly newsletter will be going monthly. This change will allow us to deliver more comprehensive coverage of industry news, regulatory updates, and key developments, with [...]
Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates. Company Updates Tower Mains is delighted to be exhibiting at the Scotsman Life Sciences Conference 2024 at the University of Strathclyde this Thursday, 28th November. Are you also attending? Come visit our stand for a [...]
Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates. Regulatory Updates MHRA launches consultation on the ICH E6 (R3) Guideline for Good Clinical Practice Annex-2 On 15th November, the Medicines and Healthcare products Regulatory Agency (MHRA) launched a consultation on the International Council for [...]
Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates. Company Updates RQA 2024 International QA Conference We had the pleasure of attending the RQA 2024 International QA Conference in Brighton last week! The conference had high energy, great networking and a broad range of [...]
Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates. Company Updates RQA 2024 International QA Conference This week, some of the Tower Mains team have been at the Research Quality Association (RQA) 2024 International QA Conference in Brighton. It’s been a fantastic experience, with [...]
Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates. Regulatory Updates MHRA guidance updates Clinical investigations. On 25th October, the Medicines and Healthcare products Regulatory Agency (MHRA) updated guidance on how to notify the MHRA of your intention to carry out a clinical investigation for [...]
Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates. Regulatory Updates Statutory Instrument laid in Parliament outlines measures for implementing Medical Device Regulatory Reform and improving patient safety On 21st October, the draft Post-market Surveillance (PMS) Statutory instrument (SI) statutory instrument was introduced to [...]
Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates. Regulatory Updates MHRA guidance updates MHRA Windsor Framework. On 11th October, the Medicines and Healthcare products Regulatory Agency (MHRA) added the September webinar to guidance on the Windsor Framework agreement on the supply of medicines [...]
Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates. Regulatory Updates MHRA launches new business plan with focus on enabling access to ground-breaking technology On 7th October, the Medicines and Healthcare products Regulatory Agency (MHRA) launched its new business plan for 2024/25, setting out [...]
Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates. Regulatory Updates MHRA guidance updates Medicines that you cannot export from the UK or hoard. On 1st October, the Medicines and Healthcare products Regulatory Agency (MHRA) added folinic acid to the list of medicines that [...]
Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates. Regulatory Updates MHRA opens applications to join the AI Airlock regulatory sandbox On 23rd September, the Medicines and Healthcare products Regulatory Agency (MHRA) launched the Artificial Intelligence (AI) Airlock regulatory sandbox, inviting AI medical device [...]
Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates. Company Updates We are thrilled to be attending the BioCap 2024 Conference on Thursday 26th September, hosted by Bionow. Are you also attending? Our Head of QA, Shona Ross, and Head of Operations, Lianne Roeling, [...]
Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates. Company Updates We are thrilled to be attending the BioCap 2024 Conference on Thursday 26th September, hosted by Bionow. Are you also attending? Our Head of QA, Shona Ross, and Head of Operations, Lianne Roeling, [...]
Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates. Regulatory Updates MHRA guidance updates Pharmacovigilance following agreement of the Windsor Framework. On 30th August, the Medicines and Healthcare products Regulatory Agency (MHRA) published guidance on the implementation of changes to pharmacovigilance for medicines authorised [...]
Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates. Regulatory Updates MHRA launches consultation on the International Council for Harmonisation (ICH) M14 On 29th August, the Medicines and Healthcare products Regulatory Agency (MHRA) launched a consultation on the ICH E2D(R1) guidelines on General principles [...]
Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates. Regulatory Updates MHRA updates Good laboratory practice (GLP) for safety tests on chemicals. On 19th August, the Medicines and Healthcare products Regulatory Agency (MHRA) updated the list of current UK GLP compliance programme members. Click [...]
Regulatory Updates MHRA updates Pre-submission advice and support On 13th August 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) shared a new guidance, offering a pre-submission service before applying for medicines Marketing Authorisations. Click to view source Medicines Pipeline data On 13th August 2024, the MHRA published a guidance [...]
Regulatory Updates Health Canada announces consultation on expanded access to clinical trials On 2nd August, Health Canada launched a consultation on draft guidance on expanded access clinical trials. Expanded access clinical trials are a type of clinical trial that provides access to investigational drugs that have the potential to treat [...]
Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates. Regulatory Updates FDA guidance updates Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products. On 25th July, the US Food & Drug Administration (FDA) published [...]
Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates. Regulatory Updates FDA updates Pediatric Inflammatory Bowel Disease: Developing Drugs for Treatment. On 22nd July, the US Food & Drug Administration (FDA) published draft guidance providing its recommendations regarding the necessary attributes of clinical studies [...]
Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates. Regulatory Updates FDA guidance updates Drugs for the Treatment of Partial Onset Seizures: Extrapolation of Efficacy from Adults to Pediatric Patients 1 Month of Age and Older. On 15th July, the US Food & Drug [...]
Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates. Company Updates We are thrilled to announce that Erin Bell has been promoted to Senior Associate. Congratulations to Erin! We can't wait to see all the amazing things you'll achieve in your new role. Regulatory [...]
Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates. Regulatory Updates FDA guidance updates Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products. On 28th June, the US Food & Drug Administration (FDA) published draft guidance intended to facilitate and [...]
Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates. Regulatory Updates FDA guidance updates CVM GFI #288 Chemistry, Manufacturing, and Controls in Support of Recombinant Protein Products for Veterinary Medicinal Use. On 24th June, the US Food & Drug Administration (FDA) published draft guidance [...]
Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates. Company Updates Tower Mains: Quality Assurance Services If you’re looking for flexible, pragmatic, and cost-effective Quality Assurance services... look no further! With over 200 years of combined experience, our team is on hand to provide [...]
Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates. Company Updates Key Considerations for a Good Lab Investigation When things don’t go to plan in a laboratory, a good investigation is pivotal to understanding what went wrong and ensuring all necessary steps have been [...]
Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates. Company Updates Key Considerations for a Good Lab Investigation When things don’t go to plan in a laboratory, a good investigation is pivotal to understanding what went wrong and ensuring all necessary steps have been [...]
Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates. Regulatory Updates MHRA guidance updates International Recognition Procedure. On 24th May, the Medicines and Healthcare products Regulatory Agency (MHRA) added information and a new webinar link to guidance on how to use the procedure for [...]
Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates. Company Updates Top tips for choosing the right QA consultancy Is your organisation considering a QA consultancy? There are many reasons why your organisation may be in the market – including growing your services, staffing [...]
Tower Mains Weekly Newsletter Company Updates Short Guide on Clinical QMS A Quality Management System (QMS) is a structured framework implemented to manage and maintain an organisation's quality objectives and expectations. It is pivotal in ensuring participant safety, data integrity, and compliance with regulatory standards. Our Senior Associate, Rita Silvestre [...]
Tower Mains Weekly Newsletter Company Updates Short Guide on Clinical QMS A Quality Management System (QMS) is a structured framework implemented to manage and maintain an organisation's quality objectives and expectations. It is pivotal in ensuring participant safety, data integrity, and compliance with regulatory standards. Our Senior Associate, Rita Silvestre [...]
Tower Mains Weekly Newsletter Company Updates Katarina: Celebrating 10 years at Tower Mains Join us in celebrating a milestone as we honour Katarina Eghan, who is marking an incredible ten years with Tower Mains. Since joining our team in 2013, Katarina has made a huge impact on the company, bringing [...]
Tower Mains Weekly Newsletter Company Updates Katarina: Celebrating 10 years at Tower Mains Join us in celebrating a milestone as we honour Katarina Eghan, who is marking an incredible ten years with Tower Mains. Since joining our team in 2013, Katarina has made a huge impact on the company, bringing [...]
Tower Mains Weekly Newsletter Company Updates We Are Hiring: Principal Associate, Clinical QA Tower Mains is looking for an experienced individual to join our team in support of clinical audit and consultancy services supporting GCP training, audit, and client QAU and QMS development. The role is flexible and can be [...]
Tower Mains Weekly Newsletter Company Updates We Are Hiring: Principal Associate, Clinical QA Tower Mains is looking for an experienced individual to join our team in support of clinical audit and consultancy services supporting GCP training, audit, and client QAU and QMS development. The role is flexible and can be [...]
Tower Mains Weekly Newsletter Company Updates We Are Hiring: Principal Associate, Clinical QA We are looking for an experienced individual to join our team in support of clinical audit and consultancy services supporting GCP training, audit, and client QAU and QMS development. The role is flexible and can be adapted [...]
Tower Mains Weekly Newsletter Company Updates We Are Hiring: Principal Associate, Clinical QA We are looking for an experienced individual to join our team in support of clinical audit and consultancy services supporting GCP training, audit, and client QAU and QMS development. The role is flexible and can be adapted [...]
Tower Mains Weekly Newsletter Company Updates FDA, Health Canada, and MHRA GCP and Pharmacovigilance Symposium 2024 Missed out on the February 2024 FDA, Health Canada, and MHRA GCP and Pharmacovigilance Symposium? Don't worry, we've got you covered... from Data Integrity and Computer System Validation to technological innovations and patient-centric approaches, [...]
Tower Mains Weekly Newsletter Company Updates We Are Hiring: Principal Associate, Clinical QA We are looking for an experienced individual to join our team in support of clinical audit and consultancy services supporting GCP training, audit, and client QAU and QMS development. The role is flexible and can be adapted [...]
Tower Mains Weekly Newsletter Regulatory Updates MHRA guidance updates Innovative Devices Access Pathway (IDAP). On 29th February, the Medicines and Healthcare products Regulatory Agency (MHRA) added Data Protection and Privacy information to guidance on the Innovative Devices Access Pathway (IDAP), a pilot designed to accelerate the development of innovative medical [...]
Company Updates Vacancy: Senior or Principal Clinical Auditor Are you a clinical auditor looking for a new role? We are looking for someone with experience in clinical trials, quality systems and audits to join our dynamic team. We’re looking for someone who is able to: Deliver GCP training to all [...]
Company Updates SQA 40th Annual Meeting Exciting News! We are Exhibiting at SQA 40th Annual Meeting! Our Head of Quality Assurance Shona Ross will be heading to Colorado for the upcoming #SQA2024 40th Annual Meeting in April. Are you also attending? Come say Hi to Shona she will be at [...]
Company Updates From Trainee to Trainer We are excited to share a milestone in the journey of our Senior Associate Rosemary Ichaba, recently she joined our Co-Founder Dr. Andrew Waddell as a course tutor for the Research Quality Association (RQA) Auditing Course. What makes this special is that for Rosemary [...]
Tower Mains Weekly Newsletter Regulatory Updates MHRA guidance updates Paclitaxel coated devices (PCD) used in the treatment of peripheral arterial disease. On 5th February, the Medicines and Healthcare products Regulatory Agency (MHRA) published updated guidance on PCD used in the treatment of peripheral arterial disease. Following a review, the agency [...]
Tower Mains Weekly Newsletter Regulatory Updates MHRA guidance updates Medicines that cannot be exported from the UK or hoard. On 30th January, the Medicines and Healthcare products Regulatory Agency (MHRA) updated the list of medicines that cannot be exported from the UK or hoarded. Click to view source Guidance on [...]
Tower Mains Weekly Newsletter Regulatory Updates MHRA guidance updates Medical devices: UK-approved bodies. On 23rd January, the Medicines and Healthcare products Regulatory Agency (MHRA) added a new entry (International (UK) Ltd Medical Devices Scope) to the guidance on UK-approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) [...]
Tower Mains Weekly Newsletter Regulatory Updates MHRA guidance updates Project Orbis On 12th January, the Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance concerning Project Orbis and ILAP to express that it is no longer a requirement to obtain an Innovation Passport as part of the Project Orbis [...]
Tower Mains Weekly Newsletter Company Updates Happy New Year from the Tower Mains team Happy New Year from the Tower Mains team. Thank you to all our clients and collaborators for your continued support, and here's to a fantastic year ahead! Regulatory Updates MHRA guidance updates Exporting active substances. On [...]
Tower Mains Weekly Newsletter Company Updates Merry Christmas from the Tower Mains team A very Merry Christmas from the Tower Mains team. We would like to thank all our clients and collaborators for your support over the past year, and we look forward to working with you next year. We [...]
Tower Mains Weekly Newsletter Regulatory Updates MHRA guidance updates International Recognition Procedure. On 8th December, the Medicines and Healthcare products Regulatory Agency (MHRA) added submission dates for Recognition B which align with CHM dates for New Active Substances (NAS). Click to view source COVID-19 test validation approved products. On 13th [...]
Tower Mains Weekly Newsletter Regulatory Updates MHRA guidance updates Register medical devices to place on the market. On 1st December, the Medicines and Healthcare products Regulatory Agency (MHRA) provided clarification concerning fees and actions required to change the legislation of a registered device. Click to view source The Innovative Devices [...]
Tower Mains Weekly Newsletter Regulatory Updates MHRA guidance updates Valproate use by women and girls. On 28th November, the Medicines and Healthcare products Regulatory Agency (MHRA) added information on the valproate registry to guidance on the risks of taking the drug during pregnancy. Click to view source Safety Public Assessment [...]
Tower Mains Weekly Newsletter Company Updates Good practices are good practices and at the core of this lies data integrity and the ability to use that to reconstruct what worked and what didn’t, which is why Tower Mains collaborated with Glasgow Caledonian University to reinforce why these – particularly good [...]
Tower Mains Weekly Newsletter Company Updates When things don’t go to plan in a laboratory, a good investigation is pivotal to understanding what went wrong and ensuring all necessary steps have been taken to identify the error, understand the root cause and prevent recurrence. Our new ‘Conducting Laboratory Investigations’ course [...]
Tower Mains Weekly Newsletter Company Updates New Course: Conducting Laboratory Investigations When things don’t go to plan in a laboratory, a good investigation is pivotal to understanding what went wrong and ensuring all necessary steps have been taken to identify the error, understand the root cause and prevent recurrence. Our [...]
Tower Mains Weekly Newsletter Company Updates New Course: Conducting Laboratory Investigations When things don’t go to plan in a laboratory, a good investigation is pivotal to understanding what went wrong and ensuring all necessary steps have been taken to identify the error, understand the root cause and prevent recurrence. Our [...]
Tower Mains Weekly Newsletter Company Updates New Course: Conducting Laboratory Investigations. When things don’t go to plan in a laboratory, a good investigation is pivotal to understanding what went wrong and ensuring all necessary steps have been taken to identify the error, understand the root cause and prevent recurrence. Our [...]
Tower Mains Weekly Newsletter Company Updates New Course: Conducting Laboratory Investigations. When things don’t go to plan in a laboratory, a good investigation is pivotal to understanding what went wrong and ensuring all necessary steps have been taken to identify the error, understand the root cause and prevent recurrence. Our [...]
Tower Mains Weekly Newsletter Company Updates New Course: Conducting Laboratory Investigations. When things don’t go to plan in a laboratory, a good investigation is pivotal to understanding what went wrong and ensuring all necessary steps have been taken to identify the error, understand the root cause and prevent recurrence. Our [...]
Tower Mains Weekly Newsletter Regulatory Updates MHRA guidance updates International Recognition Procedure. On 3rd October, the Medicines and Healthcare products Regulatory Agency (MHRA) published a webinar providing information on guidance on the international recognition route for medicines utilising pre-existing approvals from Australia, Canada, the European Union, Japan, Switzerland, Singapore, and [...]
Tower Mains Weekly Newsletter Regulatory Updates MHRA issues latest Drug Safety Update newsletter On 26th September, the Medicines and Healthcare products Regulatory Agency (MHRA) issued the September issue of its Drug Safety Update newsletter from the agency and its independent advisor, the Commission on Human Medicines. Click to view source [...]
Tower Mains Weekly Newsletter Regulatory Updates MHRA launches pathway for innovative technologies On 19th September, the Medicines and Healthcare products Regulatory Agency (MHRA) announced the launch of the Innovative Devices Access Pathway (IDAP), a program designed to accelerate the development of cost-effective medical devices and their integration into the UK [...]
Tower Mains Weekly Newsletter Regulatory Updates MHRA guidance updates Medicines: Apply for a parallel import licence. On 12th September, the Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance on getting a parallel import licence for medicines in the UK, including pharmacovigilance requirements and submitting an application. Click to [...]
Tower Mains Weekly Newsletter Company Updates MHRA guidance updates Export drugs and medicines: special rules. On 5th September, the Medicines and Healthcare products Regulatory Agency (MHRA) updated guidance on getting permission to export certain drugs and medicines. Details on applying for an export licence were removed and linked to the [...]
Tower Mains Weekly Newsletter Regulatory Updates Revised Annex 1 Becomes Effective As of 25th August, the Annex 1 revision is finally operational, manufacturers in the EU must be compliant with the GMP guideline updates. Revision to the document has been made to reflect changes in regulatory and manufacturing environments. The [...]
Tower Mains Weekly Newsletter Industry Updates EMA reviewing data on paternal exposure to valproate On 16th August, the European Medicines Agency (EMA) announced its Pharmacovigilance Risk Assessment Committee (PRAC) is reviewing data on the potential risk of neurodevelopmental disorders (NDDs) in children conceived by fathers taking valproate medicines. The review [...]
Tower Mains Weekly Newsletter Regulatory Updates MHRA guidance updates MHRA performance data for assessment of clinical trials and established medicines. On 15th August, the Medicines and Healthcare products Regulatory Agency (MHRA) published performance metrics for clinical trials and established medicines assessment. Click to view source COVID-19 test validation approved products. [...]
Tower Mains Weekly Newsletter Company Updates We are delighted to announce that we have moved our office to Newington Business Centre, 5, Dalkeith Road Mews, Edinburgh, EH16 5GA. We couldn't be more excited about the possibilities our new office will bring and as we settle into our new space, we [...]
Tower Mains Weekly Newsletter Company Updates We are delighted to announce that we have moved our office to Newington Business Centre, 5, Dalkeith Road Mews, Edinburgh, EH16 5GA. We couldn't be more excited about the possibilities our new office will bring and look forward to settling into our new home [...]
Tower Mains Weekly Newsletter Regulatory Updates MHRA updates Annual conflicts of interest report. On 25th July, the Medicines and Healthcare products Regulatory Agency (MHRA) published its 2022 annual conflict of interest compliance report. This outlines the potential conflicts of interest (COI) arising from the operation of the three centres of [...]
Tower Mains Weekly Newsletter Regulatory Updates MHRA guidance updates Register medical devices to place on the market. On 19th July, updated guidance and a template for extended CE certificate validity under EU MDR Article was added to the Medicines and Healthcare products Regulatory Agency (MHRA) guidance on registering medical devices [...]
Tower Mains Weekly Newsletter Regulatory Updates MHRA guidance updates MHRA phase I accreditation scheme. On 10th July, the Medicines and Healthcare products Regulatory Agency (MHRA) updated the list of accredited phase I units in the guidance on joining the scheme. Click to view source Borderline products: how to tell if [...]
Tower Mains Weekly Newsletter Regulatory Updates Timeframe for accepting CE-marked medical devices in Great Britain extended On 1st July, the Medicines and Healthcare products Regulatory Agency (MHRA) announced regulations (The Medical Devices (Amendment) (Great Britain) Regulations 2023) that enable CE-marked medical devices to be accepted in Great Britain for defined periods [...]
