Tower Mains Weekly Newsletter
Industry Updates
EMA recommends approval of second adapted Spikevax vaccine
On 19th October, the European Medicines Agency (EMA) announced its human medicines committee (CHMP) has recommended authorising an adapted Spikevax COVID-19 vaccine targeting the Omicron subvariants BA.4 and BA.5 in addition to the original strain of SARS-CoV-2. The adapted vaccine, Spikevax bivalent Original/Omicron BA.4-5, is recommended for adults and children from 12 years of age who have already had a primary vaccination course against COVID-19.
EMA recommends approval of Comirnaty and Spikevax COVID-19 vaccines for children from 6 months of age
On 19th October, the EMA announced its human medicines committee has recommended extending the use of Comirnaty and Spikevax targeting the original strain of SARS-CoV-2. The Committee recommended including the use in children aged 6 months to 4 years for Comirnaty and use in children aged 6 months to 5 years for Spikevax. Compared to the doses for already authorised age groups, the doses of both vaccines in the new younger age groups will be lower and both vaccines are given as injections in the muscles of the upper arm or the thigh.
FDA publishes guidance documents intended to support innovative products that benefit animal health
On 20th October, the US Food and Drug Administration (FDA) issued final guidance #253, “Good Manufacturing Practice for Animal Cells, Tissues, and Cell- and Tissue-Based Products” and final guidance #254, “Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based Products.” These guidance documents are intended to support the development of promising and innovative products that can benefit animal health by providing product-specific recommendations that will help developers of these products meet existing FDA manufacturing requirements.
FDA: Breakthrough Devices Program
On 20th October, the FDA issued draft guidance to propose select updates to the FDA guidance document “Breakthrough Devices Program Guidance for Industry and Food and Drug Administration Staff”. This guidance proposes updates to the guidance that clarifies how the program may apply to certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions in populations impacted by health and/or health care disparities.
ICH M11 draft Guideline reaches Step 2 of the ICH process
On 21st October, the International Council for Harmonisation (ICH) announced the ICH M11 draft Guideline on Clinical electronic Structured Harmonised Protocol (CeSHarP), Technical Specification, and Template reached Step 2 of the ICH process. The new guideline provides comprehensive clinical protocol organisation with standardised content, with a Template that presents the format and structure of the protocol, including the table of contents, common headers, and contents; and a Technical Specification which presents the conformance, cardinality, and other technical attributes that enable the interoperable electronic exchange of protocol content.
MHRA introducing 12-month extension to the implementation of the future Medical Device Regulations
On 25th October, the Medicines and Healthcare products Regulatory Agency (MHRA) announced it will be introducing a 12-month extension to the implementation of the future Medical Device Regulations, intending to bring the new regulations into force by July 2024. The future Medical Device Regulations is a substantial reform of the current framework as outlined in the government response. The government is committed to ensuring that there is a proportionate approach to its implementation, which supports system readiness and minimises the risk of supply disruptions for UK patients.
ICH E19 Introductory Training Presentation available on the ICH website
Following the ICH E19 Guideline on A Selective Approach to Safety Data Collection in Specific Late-stage Pre-approval or Post-approval Clinical Trials reaching Step 4 of the ICH Process in September 2022, the Expert Working Group have developed a Step 4 Introductory Training Presentation.
MHRA publishes letters and medicine recalls sent to healthcare professionals in September 2022
On 25th October, the MHRA issued a summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices in September 2022.
Issue Number: WN00084
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