Tower Mains Weekly Newsletter
It’s our birthday! This month Tower Mains celebrates its 20-year anniversary, and we would like to say a huge thank you to everybody who has contributed to our success over the years, and we look forward to providing expert quality services for many years to come.
Keep your eyes peeled for more ways in which we will be celebrating this huge milestone.
European Commission publishes draft Q&A on Clinical Trials Regulation (EU) No 536/2014
On 14th October 2021, the European Commission published draft questions and answers on the Clinical Trials Regulation (EU) No 536/2014.
MHRA updates guidance on pharmacovigilance procedures
On 14th October 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance on its approach to pharmacovigilance. The guidance was updated to provide clarity on submission and documentation requirements for various pharmacovigilance procedures including where the reliance procedure is used.
EMA recommends first-in-class medicine to treat aggressive form of breast cancer
On 15th October 2021, the European Medicines Agency (EMA) announced it had recommended granting a marketing authorisation in the EU for Trodelvy, a first-in-class medicine to treat adult patients with unresectable or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them for advanced disease. The opinion adopted by the CHMP is an intermediary step on Trodelvy’s path to patient access and will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation.
MHRA updates guidance on ‘grandfathering’ and managing the lifecycle changes of medicinal products
On 15th October 2021, the MHRA updated its guidance on converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs), ‘grandfathering’ and managing lifecycle changes, Further guidance on what to submit if the converted licence should be cancelled in mainland UK between 31 December 2020 and 31 December 2021 was added.
MHRA updates guidance on its phase I accreditation scheme
On 18th October 2021, the MHRA updated its guidance on how to join the phase I accreditation scheme. An updated list of accredited units was added.
EMA announces new manufacturing sites and new formulation approval for Comirnaty
On 18th October 2021, the EMA announced its human medicines committee (CHMP) had approved two additional manufacturing sites for the production the Comirnaty COVID-19 vaccine. The new sites – both located in Italy – will produce up to 85 million additional doses in 2021. The newly approved ready-to-use formulation of Comirnaty does not require dilution prior to administration, can be stored at 2-8°C for up to 10 weeks and will be available in a 10-vial (60 dose) pack size. These differences will provide improved storage, transport and logistic options for vaccine distribution and administration. The new formulation will be available in a phased rollout starting in early 2022.
EMA starts evaluating use of Comirnaty in children aged 5 to 11
On 18th October 2021, the EMA announced it had started evaluating an application to extend the use of BioNTech/Pfizer’s COVID-19 vaccine, Comirnaty, to children aged 5 to 11. EMA’s human medicines committee (CHMP) will review the data on the vaccine, including results from an ongoing clinical study involving children aged 5 to 11, to decide whether to recommend extending its use. The CHMP’s opinion will then be forwarded to the European Commission, which will issue a final decision.
FDA approves Cyltezo, the first interchangeable biosimilar to Humira
On 18th October 2021, the US Food and Drug Administration (FDA) announced it had approved the first interchangeable biosimilar product to treat certain inflammatory diseases. Cyltezo (adalimumab-adbm), originally approved in August 2017, is both biosimilar to, and interchangeable with, its reference product Humira (adalimumab) for Cyltezo’s approved uses. Cyltezo is the second interchangeable biosimilar product approved by the agency and the first interchangeable monoclonal antibody. Once on the market, approved biosimilar and interchangeable biosimilar products can play a role in facilitating access to treatments for many serious health conditions.
MHRA issues guidance on T34 syringe drivers
On 19th October 2021, the MHRA issued a summary of actions related to problems with T34 syringe drivers. The problems include flow-related issues, battery issues, and sunlight causing bolus infusion.
ICH publishes 30th Anniversary document
On 19th October 2021, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) announced it had published a 30th Anniversary document following the agency’s 2020 celebration of 30 years of harmonisation activity. It provides an overview of ICH’s history and current work, as well as views of different stakeholders on how ICH has contributed to better health and ICH’s future directions in the next 10 years.
MHRA updates information for healthcare professionals and the public about Vaxzevria COVID-19 vaccine
On 20th October 2021, the MHRA updated information on its consultation on how medical devices will be regulated across the UK in the future. A section on webinar recordings was added.
FDA takes additional actions on the use of a booster dose for COVID-19 vaccines
On 20th October 2021, the FDA announced it had amended the emergency use authorizations (EUA) for the Moderna, Janssen and Comirnaty COVID-19 vaccines to allow for the use of a single booster dose in eligible populations.
WHO calls for action to better protect health and care workers from COVID-19
On 21st October 2021, the World Health Organisation (WHO) and its partners issued an urgent call for concrete action to better protect health and care workers worldwide from COVID-19 and other health issues. The joint statement urged for the strengthening of the monitoring and reporting of COVID-19 infections, ill-health and deaths among health and care workers
Issue Number: WN00033