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 for the markets in Great Britain and Northern Ireland. Click to view source
FDA guidance updates
Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act. On 14th July, the U.S. Food and Drug Administration (FDA) issued draft guidance describing the factors the agency considers when determining whether an applicant has demonstrated good cause for failure to comply with the timetable for completion of studies or clinical trials required under the provisions. It also provides information on relevant procedures, including how an applicant should communicate with the agency regarding compliance with these required studies and trials and describes actions the agency may take for noncompliance with the requirements. Click to view source
Qualification of Medical Device Development Tools. On 17th July, the FDA issued final guidance describing a voluntary program for the qualification of medical device development tools (MDDTs) for use in the evaluation of devices regulated by the Center for Devices and Radiological Health (CDRH). It describes the framework for the voluntary proposal and qualification of an MDDT, including definitions of applicable terms, criteria for evaluating an MDDT for a specific context of use, considerations for qualification, and the contents of a qualification package. Click to view source
Guidance for the transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation
On 19th July, the European Commission published guidance for the transition of clinical trials from the Clinical Trials Directive (CTD) to the Clinical Trials Regulation (CTR). To facilitate the transition, sponsors are encouraged to register their clinical trials under the Clinical Trials Information System (CTIS) at their earliest convenience taking into account the time needed for the approval of the applications. The questions and answers within this guidance aim to give information on the type of clinical trials that sponsors have to transfer to CTIS, on the timeline and the content of the application for mono- and multinational trials.
Industry Updates
First non-prescription daily oral contraceptive approved in the US
On 13th July, the FDA approved the Opill tablet for non-prescription use to prevent pregnancy, the first daily oral contraceptive approved for use in the US without a prescription. The agency granted the approval to Laboratoire HRA Pharma, recently acquired by Perrigo Company plc.
MHRA performance data for assessment of clinical trials and established medicines
On 14th July, the MHRA published performance metrics for the assessment of clinical trial authorisation applications and substantial amendments for the period June 2022 to July 2023, and metrics for the assessment of new marketing authorisation applications and variations for January 2023 to June 2023.
FDA approves new drug to prevent RSV in babies and toddlers
On 17th July, the FDA announced the approval of Beyfortus for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and in children up to 24 months of age who are vulnerable to severe RSV disease through their second RSV season.
EU steps up action to prevent shortages of antibiotics
On 17th July, the European Commission, the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) issued recommendations for actions to avoid shortages of key antibiotics used to treat respiratory infections for patients in the next winter season. The recommendations, developed through the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), complement the process to develop an EU list of critical medicines, and in cooperation with the EU Member States, the Commission will take operational follow-up actions, including, if necessary, possible joint procurements.
FDA publishes latest spotlight on CDER science
On 17th July, the FDA published a Spotlight on Center for Drug Evaluation and Research (CDER) Science describing a laboratory study focused on mixing an oral antacid with different foods. In the study, CDER researchers explored how pantoprazole sodium may perform differently when mixed into different food vehicles. These researchers confirmed that a laboratory assessment can detect the effect of the food vehicle on the drug performance, which has implications for evaluating drug safety and efficacy.
MHRA launches public consultation on reclassification of opioid-containing cough medicine
On 18th July, the MHRA announced it has launched a consultation on the reclassification of codeine linctus to a prescription-only medicine. The consultation – open until 15th August 2023 – has been launched after considering multiple Yellow Card reports that codeine linctus is being used recreationally for its opioid effects, rather than for its intended use as a cough suppressant.
Alliance for Genomic Discovery announces founding biopharma members
On 18th July, Illumina Inc. a company focused on DNA sequencing and array-based technologies, in collaboration with Nashville Biosciences, LLC, a leading clinical and genomic data company, announced the five founding members of the Alliance for Genomic Discovery (AGD) – AbbVie, Amgen, AstraZeneca, Bayer and Merck. The AGD is a multi-year project aiming to accelerate the development of therapeutics through large-scale genomics and the establishment of a preeminent clinical genomic resource. It will leverage Illumina’s next-generation sequencing and analysis platforms to help identify disease associations and targets for intervention by analysing WGS data derived from the Vanderbilt University Medical Centre’s extensive, high-quality biobank of more than 250,000 de-identified human DNA samples and associated clinical data.
EMA publishes reflection paper on the use of artificial intelligence in the lifecycle of medicines
On 19th July, the EMA published a draft reflection paper outlining the current thinking on the use of artificial intelligence (AI) to support the safe and effective development, regulation and use of human and veterinary medicines. The paper reflects on principles relevant to the application of AI and machine learning (ML) at any step of a medicine’s lifecycle, from drug discovery to the post-authorisation setting.
OPEN framework extended to a wider range of medicines
On 20th July, the EMA announced it has expanded the scope of the OPEN initiative from COVID-19 vaccines and treatments to a wider range of medicines, such as medicines with the potential to address antimicrobial resistance (AMR), respiratory syncytial virus (RSV) infections or newly diagnosed myelodysplastic syndromes (and other hereditary diseases). Established in 2020, OPEN allows regulators from Australia, Brazil, Canada, Japan, Switzerland and the World Health Organisation (WHO) to conduct near-concurrent reviews of certain new medicines and exchange their views and reports on the product assessments. This can help accelerate and align regulatory decisions in several regions in the world, leading to fewer questions for industry and more alignment on the product labelling, while maintaining regulators’ independence in their decision making.
Issue Number: WN00121
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