Tower Mains Weekly Newsletter

Company Updates

We are delighted to welcome Naomi Ervine to the Tower Mains team as Senior Associate. Naomi will be supporting both the internal and client Quality Systems and conducting routine vendor/study audits, primarily in the area of GCP.

Industry Updates

Access Consortium launches three-year strategy

On 5th August 2021, the Access Consortium – a coalition of regulatory authorities, including the MHRA, Health Canada, and Swissmedic – published its three-year strategy which aims to align regulatory approaches and policies to facilitate work-sharing on medicines. The plan sets out a range of objectives, including capturing lessons learned from the COVID-19 pandemic to innovate together and improve work-sharing. It highlights the increasing importance of regulatory innovation as health products evolve, increase in complexity, and become more personalised.

Click to view source             View strategic plan

ICMRA publishes recommendations to facilitate the use of track and trace systems at global level

On 6th August 2021, the International Coalition of Medicines Regulatory Authorities (ICMRA) published recommendations to facilitate the use of track and trace systems at a global level. In the paper, international regulators emphasise that the interoperability of track and trace systems helps to protect public health by improving information sharing in case of quality defects, reducing shortages, contributing to the fight against falsified medicines and supporting pharmacovigilance activities.

Click to view source             View paper

EMA issues highlights from PRAC meeting

On 6th August 2021, the European Medicines Agency (EMA) issued highlights from its Pharmacovigilance Risk Assessment Committee (PRAC) held on the 5th of August. Highlights include updates on safety issues associated with the Janssen and Vaxzevria COVID-19 vaccines and discussions on reported cases of menstrual disorders occurring after vaccination against COVID-19.

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MHRA opens Early Access to Medicines Scheme (EAMS) consultation

On 6th August 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) published details on the Early Access to Medicines Scheme (EAMS) consultation. The UK EAMS is one of the ways through which a patient with a life-threatening or seriously debilitating condition can gain access to a medicine before it has gained approval from the UK’s MHRA. The proposal aims to ensure EAMS remains an attractive option for patients, healthcare professionals and companies, so that cutting-edge therapies are available for patients where there is an unmet clinical need. The consultation closes on 17th September 2021.

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TGA grants provisional registration to the Moderna COVID-19 vaccine in Australia

On 9th August 2021, it was announced that the Therapeutic Goods Administration (TGA) had granted provisional registration to Moderna’s COVID-19 vaccine in Australia for immunisation in individuals 18 years of age and older. Delivery of Moderna’s COVID-19 vaccine to Australia is expected to commence in the second half of September.

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MHRA updates list of medical devices given exceptional use authorisations during COVID-19 pandemic

On 11th August 2021, the MHRA updated its list of manufacturers and their medical devices which have been granted exceptional use authorisations during the COVID-19 pandemic. The list also includes manufacturers whose exemption expired or was cancelled.

Click to view source             View list

MHRA launches consultation on proposed regulatory framework for Point of Care (POC) manufacturing

On 12th August 2021, the MHRA launched a public consultation on a proposed regulatory framework for Point of Care (POC) manufacturing. The proposed framework is specifically designed to create and regulate a step change in the range of manufacturing options to enable the supply and increase the availability of innovative new medicinal products to patients. This new manufacturing and supply system in the UK healthcare system will benefit patients that currently have no or few treatment options by improving the availability of innovative medicines. The consultation will run for six weeks.

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