Tower Mains Weekly Newsletter

Industry Updates

ECDC and EMA conclude it’s too early to consider using a fourth dose of mRNA COVID-19 vaccines

On 6th April, the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency’s COVID-19 task force (ETF) concluded that it is too early to consider using a fourth dose of mRNA COVID-19 vaccines in the general population. However, both agencies agreed that a fourth dose (second booster) can be given to adults 80 years of age and above after reviewing data on the higher risk of severe COVID-19 in this age group and the protection provided by a fourth dose.

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Website issued warning letter for marketing unapproved and misbranded drugs

On 6th April, the US Food and Drug Administration (FDA) issued a warning letter to operators of a website due to the marketing of unapproved and misbranded drugs for the treatment of multiple diseases, including COVID-19.

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Cybersecurity in Medical Devices: FDA issues draft guidance document

On 8th April, the FDA issued guidance intended to provide recommendations to the industry regarding cybersecurity device design, labelling, and the recommended documentation to be included in premarket submissions for devices with cybersecurity risk. These recommendations can facilitate an efficient premarket review process and help ensure that marketed medical devices are sufficiently resilient to cybersecurity threats.

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FDA issues final guidance on clinical studies

On 8th April, the FDA issued the E8(R1) General Considerations for Clinical Studies final guidance document. As a founding regulatory member of ICH, the FDA plays a major role in the development of each of the ICH guidelines, which the FDA then adopts and issues as guidance to industry.

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EMA issues highlights from the PRAC meeting

On 8th April, the European Medicines Agency (EMA) issued meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) held on the 4th-7th April 2022. Highlights include the conclusion that there is no link between autoimmune hepatitis and mRNA COVID-19 vaccines, and the risk of medication errors due to the change in maintenance dose of Nulojix.

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ICH issues statement on the situation in Ukraine

On 11th April, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) issued a statement on the current situation in Ukraine.

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MHRA launches consultation on new Code of Practice for the Expert Advisory Committees

On 12th April, the Medicines and Healthcare products Regulatory Agency (MHRA) launched a consultation on proposals to improve and strengthen the Code of Practice for experts who provide advice on which decisions about the regulation of medicines and medical devices are based. The proposed changes also seek to encourage greater inclusion of patients and their representatives in advisory committee discussions, so that individuals with personal experience can contribute to discussions more easily. The consultation closes at 11:45pm (BST) the 24th of May 2022.

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EMA and EUnetHTA 21 consortium publish joint work plan

The EMA and the European Network for Health Technology Assessment (EUnetHTA) 21 consortium have published their joint work plan until 2023. The focus of the plan is to prepare for the Regulation on Health Technology Assessment (EU) 2021/228 in January 2025 coming into application after a 3-year implementation period. The work plan continues the close collaboration between EMA and Health Technology Assessment (HTA) bodies in Europe, which began in 2010 through consecutive EUnetHTA Joint Actions of which the last one concluded in May 2021. This collaboration has demonstrated many synergies between regulatory evaluation and HTA along the lifecycle of medicines and aims to facilitate patients’ access to medicines in the EU.

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European Commission: Clinical Trials Regulation (EU) no 536/2014 Q&A

On 13th April, the European Commission issued the Clinical Trials Regulation (EU) No 536/2014 Questions & Answers V6 document.

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Issue Number: WN00056

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