Visit www.brookwood-global.com for further details and to order online • ONLINE TRAINING • GCLP Regs RM MD GMP NIS CDM PV GDPR GCP Keep up to date with a regular newsletter dedicated to clinical research and quality assurance – Advisor Newsletter Advisor is a quick and easy to read interactive newsletter, published 20 times per annum. It provides an ideal opportunity for busy clinical research and quality assurance professionals to keep up to date with the latest news and information. This Good Distribution Practice (GDP) course targets new hires as well as current employees needing ongoing or refresher GDP training. It explains why GDP exists, what it entails and its key requirements. The course is approved by the Royal Society of Chemistry (RSC). The course consists of the following chapters. Chapter 1: An introduction to the pharmaceutical industry This chapter provides an overview of the pharmaceutical industry and the need to regulate medicines manufacture and supply. Chapter 2: An introduction to Good Distribution Practice This chapter introduces the concept of Wholesale Dealer Authorisations and the need for GDP. GMP Click for product demo Chapter 3: The GDP guidelines The main content and requirements of the 10 chapters of GDP are explained and why these are important. Chapter 4: Working to GDP The key elements of GDP are covered, with a special focus on what GDP means for the individual working for an organization involved in the storage, transport and/or brokering of medical products. These chapters are available either as a UK or non-UK version. The UK version has references to the UK’s regulatory authority (the MHRA) and its ‘Green Guide’, whereas the non-UK version does not. Each chapter has a series of randomly selected assessment quiz questions at the end. An 80% pass mark is expected. Guidance is provided if a delegate gets an answer wrong. After successful completion of the course, a certificate including the RSC ‘Approved Training’ logo is available for download by the delegate. Good Distribution Practice ISSN 2041-367X 13 JANUARY 2025 Issue 554 Major overhaul of UK clinical trial regulations under parliamentary review New legislation has now been laid before the UK parliament to change how clinical trials are conducted in the UK. A series of new measures will be introduced by the Medicines and Healthcare products Regulatory Agency – with support from partners including the Health Research Authority, academia and researchers – that will make it faster and easier to gain approval and to run clinical trials in the UK. The changes represent the biggest overhaul of the UK clinical trial regulations in over 20 years, and will help to make the UK one of the best countries in the world in which to conduct clinical research for patients and researchers. The amended regulatory framework will speed up trial approvals and encourage innovation in trial design without compromising patient safety. Details on page 4 u UK clinical trials performance improves but further support needed The past 2 years have seen positive change for UK industry clinical trials, and the Association of the British Pharmaceutical Industry’s annual report shows evidence of continued progress. The number of pharmaceutical industry trials initiated in the UK grew in 2023 for the second year running, and for the first time since 2017 the UK’s global rankings in late-phase clinical trial initiations improved. However, the numbers remained significantly below those from 2017 and the UK is also underperforming in the delivery of industry trials to time and target, with up to 30% not recruiting the agreed participant numbers within specified timeframes. The annual report makes six recommendations on how best to help the UK to deliver the full benefits of industry trials to UK patients, the National Health Service and the economy. Further details on page 6 u EU agencies finalise common approach to data transparency in medicines regulation On 18 December 2024, the European Medicines Agency and the Heads of Medicines Agencies adopted comprehensively revised guidance on the identification of commercially confidential information (CCI) and personal data (PD) in marketing authorisation applications for human medicines. The updated document reaffirms the commitment of regulatory authorities across the European Economic Area to extensive transparency when disclosing information, both in response to access-to-documents requests and in the proactive publication of data once a medicine is authorised. The new final guidance supersedes initial guidance on this topic from 2012, describing the agreed principles on CCI and PD, and providing recommendations on whether such information can be disclosed. See page 5 u Call for more dedicated paediatric drug research Despite multiple regulatory incentives, an examination of FDA paediatric drug approvals over a 13-year period suggests that more needs to be done to encourage the development of treatments for conditions that are unique to children. As reported in JAMA Pediatrics, between 1 January 2011 and 31 December 2023 orphan indications (for rare diseases) were more likely than non-orphan indications to be approved for paediatric use, and most non-orphan indications required the support of one of the three paediatricspecific regulatory programmes available in the USA. The researchers suggest that there is a need to plug gaps in the current regulatory process in order to maximise paediatric drug development. More on page 9 u page 2 u ISSN 2041-367X 3 FEBRUARY 2025 Issue 555 CDER report details approvals of safe and effective therapies in 2024 The FDA’s Center for Drug Evaluation and Research (CDER) has issued its ‘New Drug Therapy Approvals 2024’ report. The report highlights the work of the Center’s review teams in their thorough evaluation and approval of safe and effective therapies, resulting in multiple new medicinal products that are likely to have a significant positive impact on public health. The 2024 approvals include a significant number of new therapies for rare diseases and a record annual total for biosimilar products. The report also notes the importance of innovative regulatory approaches to help expedite drug review. See page 6 u EU rules on health technology assessments take effect The new Health Technology Assessment Regulation (Regulation (EU) 2021/2282) came into effect on 12 January 2025, and the European Medicines Agency has committed to supporting enhanced EU collaboration to allow faster and wider access to innovative health technologies. Health technology assessments (HTAs) help EU Member States to decide on the use, price and reimbursement level of new health technologies, and support them in ensuring the quality, accessibility and sustainability of healthcare. Close interaction between regulators, HTA bodies and other relevant parties is critical to enabling patient access to new treatments, for the wider benefit of public health. Details on page 4 u GCP lessons: FDA warns Polish investigator over record keeping and protocol compliance An investigator in Poland has received an FDA warning letter highlighting violations of the federal regulations during the conduct of a Phase 3 clinical study. The warning letter highlights how, on several occasions, the information provided to the FDA during the inspection was subsequently contradicted in the investigator’s written response to the inspection findings. Additionally, the inspector tried to attribute the lack of contemporaneous record keeping to internet connectivity issues resulting from the effects of the COVID-19 pandemic. However, the FDA noted that the delays in recording data took place prior to the start of the pandemic. The agency also highlighted that the times and/or dates of assessments appear to have been edited to look as if they were recorded during the assessments. Details on page 9 u page 2 u ABPI demands regulatory renewal across UK life sciences In a statement accompanying a new report issued on 4 December 2024, the Association of the British Pharmaceutical Industry (ABPI) notes that it is now time to explore how the UK pharmaceutical industry can contribute to shaping a globally leading UK regulatory framework for innovative medicines. The ABPI wants the UK to be the best place in the world to research, develop and use the medicines and vaccines of the future. In its report (entitled ‘Enhancing the Role of UK Medicine Regulation’) the ABPI explores the crucial role of regulatory excellence in driving innovation and early access, supporting patient trust and attracting investment into the UK. More on page 8 u Follow us on LinkedIn for the latest developments in clinical research, GCP and quality assurance. ISSN 2041-367X 17 FEBRUARY 2025 Issue 556 Editorial 2025 is a defining year in the regulation of clinical trials in humans. The ICH GCP guideline has been hugely changed, for the first time since its original release in 1996. The E6(R3) Guideline will define how clinical trials are to be conducted globally for years to come. Before the Step 4 (final) version of E6(R3) was released, over 7000 comments received during the public consultation on the Step 2 draft (issued in May 2023) had to be considered. This was indeed a major workload for the Expert Working Group (EWG), but the result speaks for itself and the EWG members should be congratulated. We now have a final guideline that encompasses modern trends and developments in clinical trials, such as new data acquisition tools and electronic methodologies. E6(R3) is divided into a set of overarching Principles of GCP, and guidance in the forms of Annexes 1 and 2. Annex 2 is still to be finalised. It is vital that sponsors, investigators and other stakeholders become familiar with and adhere to the Principles of GCP. These will be incorporated into some regional regulations, such as those of the UK. This issue of Advisor – written by Jane Baguley – reviews what has changed between the draft Step 2 and the final Step 4 versions of the E6(R3) Guideline, highlighting some of the key changes. We hope that you find it useful. The development of an updated GCP guideline On 6 January 2025, the ICH Harmonised Guideline ‘Guideline for Good Clinical Practice E6(R3)’ was endorsed by the Regulatory Members of the ICH Assembly under Step 4 of the ICH process. By reaching this milestone, the final draft is recommended for adoption to the regulatory bodies of the ICH regions. GCP is an international ethical, scientific and quality standard for the conduct of trials that involve human participants. Conducting clinical trials in accordance with this standard helps to assure that the rights, safety and well-being of trial participants are protected; that trial conduct is consistent with the principles that have their origin in the Declaration of Helsinki; and that the results are reliable. Back in 2019 ICH noted that, in the two decades since the ICH E6 Guideline was first drafted, clinical trials had become more complex in their design, utilisation of technology, quantity of data collected and involvement of central testing facilities or other service providers. E6(R2) was issued to address the emerging use of electronic data sources and risk management processes, but clinical trials continued u page 2 KEEP UP TO DATE This course has been approved by the RSC
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