Tower Mains Weekly Newsletter
Company Updates
Tower Mains blog: How to create a comfortable working environment as an auditor
When describing an audit, the word ‘comfortable’ is not the first word that springs to mind, but why can’t this be a word associated with the auditing environment?
Our Senior Associate, Rosemary Ichaba, believes that when we are comfortable, we can work to our optimum, so creating a comfortable working environment for our auditees could help create more efficient, timely and successful audits. To read her tips on how to achieve this, click here.
Regulatory Updates
FDA announces steps to modernise clinical trials
On 5th June, the US Food and Drug Administration (FDA) published draft guidance entitled “E6(R3) Guideline for Good Clinical Practice,” which was adopted from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) recently updated E6(R3) draft guideline. The guidance aims to modernise the design and conduct of clinical trials, making them more agile without compromising data integrity or participant protections. It encourages innovation, focuses on quality, and establishes proportionate and risk-based approaches for conducting clinical trials while minimising unnecessary complexities.
Further FDA guidance updates
- Non-clinical evaluation of the immunotoxic potential of pharmaceuticals. On 5th June, the FDA published final guidance to assist sponsors in the non-clinical evaluation of the immunotoxic potential of pharmaceuticals. Immunotoxicity is, for this guidance, defined as unintended immunosuppression or stimulation, which can include adverse effects of exaggerated pharmacology of pharmaceuticals that are intended to act as immunomodulators. The guidance applies to drug products, including small molecule drugs and oligonucleotides, as well as certain biological products such as biotechnology-derived therapeutic proteins (referred to herein as biopharmaceuticals). Click to view source
- Drug-drug interaction assessment for therapeutic proteins guidance for industry. On 6th June, the FDA published final guidance to help sponsors of investigational new drug (IND) applications and applicants of biologic license applications (BLAs) determine the need for drug-drug interaction (DDI) studies for a therapeutic protein by providing recommendations for a systematic, risk-based approach. Click to view source
EU and US agree on simpler rules for more trade in veterinary products
During the latest EU-US Trade and Technology Council, held on the 31st May 2023, the US and the EU reached an agreement to mutually recognise the results of pharmaceutical Good Manufacturing Practices (GMP) inspections for veterinary products. This means that veterinary products manufactured in the EU can now be exported to and marketed in the US without a prior US inspection of the EU manufacturers, and vice versa. This follows an earlier, similar decision for human medicines.
Industry Updates
Janssen COVID-19 vaccine EUA revoked in US
On 1st June, the FDA revoked the emergency use authorisation (EUA) of the Janssen COVID-19 vaccine. On 22nd May 2023, Janssen Biotech Inc. requested the voluntary withdrawal of the EUA for this vaccine and informed the FDA that the last lots of the vaccine purchased by the U.S. Government have expired, there is no demand for new lots of the vaccine in the U.S., and they do not intend to update the strain composition of this vaccine to address emerging variants.
Virtual live hands-on training course for clinical trial sponsors using EudraVigilance system
On 1st June, the European Medicines Agency (EMA) published information on its virtual live hands-on training course for clinical trial sponsors using the EudraVigilance system. This will be held on the 27th -29th of November 2023.
FDA warned against using products marketed to treat molluscum
On 1st June, the FDA confirmed that there are no FDA-approved products to treat molluscum, a common skin infection that some people try to self-diagnose and treat. Consumers are warned not to use products that claim to treat molluscum, even if they say they are “FDA-approved” or “made in an FDA facility.”
EMA publishes latest issue of its Veterinary Medicines Highlights
On 2nd June, the EMA published the May issue of its Veterinary Medicines Highlights, a quarterly newsletter featuring news, activities and updates from the Veterinary Medicines Division. Highlights include the progress on the EU Veterinary Big Data work plan to 2025, Veterinary IT system updates and the Committee for Veterinary Medicinal Products (CVMP) statistics for Q1 and Q2.
FDA issues update on medical device reports
On 2nd June, the FDA provided an update on medical device reports it received that are reportedly associated with the breakdown or suspected breakdown of the polyester-based polyurethane (PE-PUR) foam used in the Philips Respironics ventilators, BiPAP machines, and CPAP machines included in the recall announced in June 2021. Since April 2021, the FDA has received more than 105,000 medical device reports, including 385 reports of death.
European Commission and WHO launch digital health initiative to strengthen global health security
On 5th June, the World Health Organisation (WHO) and European Commission announced the launch of a landmark digital health partnership. In June 2023, the WHO will take up the EU system of digital COVID-19 certification to establish a global system that will help facilitate global mobility and protect people across the world from ongoing and future health threats, including pandemics. This is the first element of the WHO Global Digital Health Certification Network (GDHCN) that will develop a wide range of digital products to deliver better health for all.
Man sentenced to five years in prison for the illegal possession and intent to supply prescription medicines worth £2m
On 5th June, the MHRA released information regarding the sentencing of a West Midlands man for the illegal possession and intent to supply prescription medicines worth £2m.
New COVID-19 vaccine concept successfully tested
On 5th June, the University of Basel announced that, in collaboration with Rocketvax AG, a Swiss biotech startup, it has developed a new approach for a COVID-19 vaccine based on a modified coronavirus that can enter body cells and trigger an effective immune response but cannot multiply in the body. In animal studies, the vaccine effectively protected against the disease and prevented virus transmission. The mechanism of action for the single-cycle virus approach has been successfully confirmed, and further preclinical studies will select the clinical candidate.
EMA and ECDC statement on updating COVID-19 vaccines to target new SARS-CoV-2 virus variants
On 6th June, the EMA and The European Centre for Disease Prevention and Control (ECDC) issued a joint statement on adapted COVID-19 vaccines and considerations for their use during the upcoming autumn 2023 vaccination campaigns. The statement includes:
- Proposed revision of product information
- Recommended groups to be targeted by vaccination campaigns in 2023
- Factors to be considered in autumn vaccination campaigns.
Issue Number: WN00115
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