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 will be closed from Friday 22nd of December and will be back on Wednesday 3rd of January 2024.

New 2024 course dates available

Looking to boost your skills and knowledge? Check out our range of open training courses, covering a range of topics relating to the regulatory industry, including our new and updated courses for 2023/24:

  • 13th February: Fundamentals of GCP (including ICH E6 R3 updates), led by Fiona Waddell
  • 14th-15th February: Research Audit & Inspection, led by Dr Andrew Waddell
  • 22nd February: Conducting Laboratory Investigations, led by Erin Bell and Anna Lothian

If you are interested in discussing your specific training requirements or if you wish to book for your group or organisation, please don’t hesitate to contact training@towermains.com or click here.

Regulatory Updates

MHRA guidance updates

  • Access New Active Substance and Biosimilar Work Sharing Initiatives. On 15th December, the Medicines and Healthcare products Regulatory Agency (MHRA) updated the Operational Procedures for the New Active Substance Work Sharing Initiative (NASWSI). Click to view source
  • International Recognition Procedure. On 20th December, a recording of the ‘MHRA International Recognition Webinar November 2023’ was added to guidance on how to use the International Recognition Procedure for medicines licensing applications. Click to view source

FDA guidance updates

  • Use of Real-World Evidence to support regulatory decision-making for medical devices. On 14th December, the US Food & Drug Administration (FDA) published draft guidance to clarify how the agency evaluates real-world data (RWD) to determine whether they are of sufficient quality for generating real-world evidence (RWE) that can be used in FDA regulatory decision-making for medical devices. This draft guidance also proposes expanded recommendations to the 2017 guidance, Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.  Click to view source
  • Clinical pharmacology considerations for peptide drug products. On 14th December, draft guidance was issued providing recommendations to assist industry in the development of peptide drug products. Specifically, this guidance, when finalised, will describe the FDA’s current thinking regarding the impact of clinical pharmacology considerations, including hepatic impairment, drug-drug interactions (DDIs), QTc prolongation risk, and immunogenicity risk on a peptide drug product’s pharmacokinetics (PK), safety, and efficacy. Click to view source
  • Priority Zoonotic Animal Drug Designation and review process. On 16th December, draft guidance was published outlining the eligibility criteria a new animal drug should meet to obtain PZAD designation and describes the process sponsors may use to request such designation. Click to view source
  • Development of monoclonal antibody products targeting SARS-CoV-2 for Emergency Use Authorisation. On 21st December, final guidance was published providing recommendations to sponsors on the development of monoclonal antibody products targeting SARS-CoV-2 intended for the prevention or treatment of COVID-19, including addressing the impact of emerging variants. Click to view source

ICH publishes overview of comments received on ICH E6 (R3)

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has published the overview of comments on ICH E6 (R3) Guideline for Good Clinical Practice.

Click to view source

MHRA Inspectorate: GMP & GDP certificate validity period extended

The MHRA announced that, in consultation with international partners, it has decided to continue the extension of the validity date of Good Manufacturing Practice (GMP)  and Good Distribution Practice (GDP) certificates until 2024 or until the conclusion of the next inspection, whichever comes first, except where clarifying remarks in the certificate state otherwise. The agency reserves the right to perform risk-based supervision of sites by either on-site or remote inspections and, based on the outcome, may continue to issue, withdraw, or restrict certificates as appropriate.

Click to view source

Industry Updates

FDA issues warnings to nine manufacturers and distributors of unapproved antimicrobials for animals

On 14th December, announced the issue of nine warning letters to manufacturers and distributors of unapproved and misbranded antimicrobial animal drugs for violations of federal law. The agency is concerned because these products contain antimicrobials that are important in human medicine and using them without medical oversight contributes to the development of antimicrobial resistance.

Click to view source

First gene editing therapy to treat beta-thalassemia and severe sickle cell disease

On 15th December, the European Medicines Agency (EMA) announced the recommendation of the first medicine using CRISPR/Cas9, a novel gene-editing technology. Casgevy is indicated for the treatment of transfusion‑dependent beta-thalassemia and severe sickle cell disease in patients 12 years of age and older for whom haematopoietic stem cell transplantation is appropriate and a suitable donor is not available. The therapy may free patients from the burden of frequent transfusions and painful vaso-occlusive crises that occur when sickled red blood cells block small blood vessels and has the potential to significantly improve their quality of life.

Click to view source

MHRA publishes the latest drug safety update

On 18th December, the MHRA published the December issue of the Drug Safety Update newsletter from the agency and its independent advisor, the Commission on Human Medicines.

Click to view source

EMA and HMAs issue work plan to guide the use of AI in medicine regulation

On 18th December, the EMA, and the Heads of Medicines Agencies (HMAs) published an Artificial Intelligence (AI) work plan to 2028, setting out a collaborative and coordinated strategy to maximise the benefits of AI to stakeholders while managing the risks. The work will help the European Medicines Regulatory Network (EMRN) to embrace the opportunities of AI for personal productivity, automating processes and systems, increasing insights into data, and supporting more robust decision-making to benefit the public and animal health.

Click to view source

Novo Nordisk Foundation establishes new $260m vaccine initiative to combat airborne infections

On 18th December, the Novo Nordisk Foundation announced it is committing up to $260million to establish a state-of-the-art research and vaccine development initiative to create new or improved vaccines for some of the deadliest respiratory diseases. Developed in partnership with the University of Copenhagen, it is the first vaccine initiative to focus exclusively on understanding how to generate immunity in the airway itself and is a potentially revolutionary means to block infection and prevent airborne diseases from spreading between humans.

Click to view source

BioMed X Institute and Ono Pharmaceutical launch new joint cancer research project

On 19th December, BioMed X announced a new joint research project with Ono Pharmaceutical Co. marking the start of the collaboration between the German biomedical research institute and one of the largest pharmaceutical companies in Japan. The project entitled “New Strategies to Engage Neutrophils in Solid Tumours” will be hosted by the BioMed X Institute in Heidelberg, Germany, and the goal of the project is to design next-generation immunotherapies by leveraging the antitumor effects of neutrophils.

Click to view source

Q&A: Expediting quality development for FDA’s breakthrough therapies and EMA’s PRIME Programs

On 19th December, the FDA and the EMA published the “EMA–FDA joint Q&As on Quality and GMP aspects of PRIME/Breakthrough therapy applications” document supporting quality development for FDA’s Breakthrough Therapy (BT) designation and EMA’s Priority Medicines (PRIME) scheme programs for patients with unmet medical needs. These Q&As are a result of a 2018 workshop held by both agencies where regulators and industry discussed quality challenges and scientific and regulatory approaches for facilitating the development and preparation of pharmaceutical quality data packages.

Click to view source

EMANS midterm report finds transformative change in the system across key strategic areas

On 20th December, it was announced that, according to the midterm report of the European Medicines Agencies Network Strategy (EMANS), the European regulatory network is on track to meet its strategic goals and objectives covering availability and accessibility of medicines; data analytics, digital tools, and digital transformation; innovation; antimicrobial resistance and other emerging health threats; supply-chain challenges; sustainability of the network and operational excellence.

Click to view source

Issue Number: WN00143

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