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 December, updated the list of new products approved under the Medical Device Coronavirus Test Device Approvals Amendment Regulations list as an Excel spreadsheet. Click to view source
FDA guidance updates
- Presenting quantitative efficacy and risk information in direct-to-consumer (DTC) promotional labelling and advertisements. On 11th December, the US Food and Drug Administration (FDA) issued final guidance providing recommendations for presenting quantitative efficacy and risk information in direct-to-consumer (DTC) promotional labelling and advertisements for prescription human drug and biological products and prescription animal drugs and in DTC promotional labelling for non-prescription animal drugs (collectively, promotional communications). Click to view source
- Advanced manufacturing technologies designation program. On 12th December, draft guidance was published providing recommendations to persons and organisations interested in participating in the FDA’s Advanced Manufacturing Technologies Designation Program, which is intended to facilitate the development of drugs, including biological products, manufactured using an AMT that has been designated as such under the program. Click to view source
- Study data technical conformance guide. On 13th December, the FDA published the Study Data Technical Conformance Guide, which provides specifications, recommendations, and general considerations on how to submit standardised study data using FDA-supported data standards located in the FDA Data Standards Catalog. Click to view source
- Clinical pharmacology considerations for peptide drug products. On 13th December, draft guidance was published with recommendations to assist industry in the development of peptide drug products.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
MHRA publishes outcome of consultation on how the agency communicates with healthcare professionals
On 11th December, the MHRA published the outcome of a consultation on how the agency communicates with healthcare professionals to improve medicines and medical devices’ safety. The 16-week consultation gathered insight and recommendations through an online survey, interviews and focus groups, and several organisations also submitted written responses. The feedback was consistent, and the MHRA values clear and direct suggestions about what works and what needs improvement. This addressed not only safety communications and websites but also how the MHRA raises awareness of its activities and engages with HCPs and organisations.
Industry Updates
European Commission extends the deadline for PRAC and COMP interest
On 7th December, the European Commission extended the submission deadline to appoint Independent Scientific Experts to the Pharmacovigilance Risk Assessment Committee (PRAC) and the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA). The new final deadline for submission of applications is 12pm, Brussels time, 21st December 2023.
Family locked up for illegal sale and supply of unlicensed medicines worth £1.5m
On 8th December, three men were sentenced to a total of three years at Manchester Crown Court after pleading guilty to the illegal sale and supply online of prescription-only medicines and controlled Class B and Class C drugs with a street value of more than £1.5m following investigations by the MHRA.
UKHSA publishes update on influenza A(H1N2)v
On 11th December, the UK Health Security Agency (UKHSA) published its investigation findings on the recent case of influenza A(H1N2)v following its detection as part of routine national flu surveillance undertaken by UKHSA and the Royal College of General Practitioners (RCGP).
Revolutionary system could transform the fight against hospital infections
On 11th December, Pinpoint Medical, in conjunction with the University of Glasgow, announced the development of a revolutionary, simple-to-use system that not only detects but also eliminates airborne pathogens aiming to combat the spread of infections in hospitals. The system harnesses almost a decade of cutting-edge research at the university funded mainly by the Engineering and Physical Sciences Research Council (EPSRC, part of UK Research and Innovation) through an Innovation Fellowship and Impact Acceleration Account.
FDA approves first gene therapies to treat patients with sickle cell disease
On 12th December, the FDA approved two milestone treatments, Casgevy and Lyfgenia, representing the first cell-based gene therapies for the treatment of sickle cell disease (SCD) in patients 12 years and older. Additionally, one of these therapies, Casgevy, is the first FDA-approved treatment to utilise a type of novel genome editing technology, signalling an innovative advancement in the field of gene therapy.
FDA forms new advisory committee for evaluation of genetic metabolic disease treatments
On 12th December, the FDA announced a new advisory committee related to potential treatments for genetic metabolic diseases. When called upon, the Genetic Metabolic Diseases Advisory Committee will provide the FDA with independent, knowledgeable advice and recommendations on technical, scientific and policy issues around medical products for genetic metabolic diseases. Committee members will evaluate evidence on key issues about the applications brought before the advisory committee and offer their recommendations for FDA consideration.
First version of the Union list of critical medicines agreed to help evade potential shortages in the EU
On 13th December, the European Commission (EC), the Heads of Medicines Agencies (HMA) and the EMA published the first version of the Union list of critical medicines. It contains more than 200 active substances of medicines for human use considered critical for healthcare systems across the EU/EEA, for which continuity of supply is a priority and shortages should be avoided. The European medicines regulatory network will prioritise critical medicines for EU-wide actions to strengthen their supply chain.
ACSR to use digitised pathology to advance scientific exploration of cancer in people living with HIV
On 13th December, the National Institutes of Health (NIH)-funded AIDS and Cancer Specimen Resource (ACSR) announced it is using software from Proscia®, a leading provider of digital and computational pathology solutions, to encourage scientific exploration and discovery in cancer in PLWH. Concentriq® for Research has enabled the ACSR to provide near real-time access to pathology data to investigators around the world.
Issue Number: WN00142
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