Tower Mains Weekly Newsletter
Regulatory Updates
MHRA appoints first UK Approved Body to certify medical devices since Brexit
On 29th September, the Medicines and Healthcare products Regulatory Agency (MHRA) confirmed that DEKRA Certification UK Ltd has joined the three current UK Approved Bodies, increasing the UK’s capacity to process conformity assessments for medical devices to ensure safe and effective devices reach the UK public. DEKRA is the first organisation to complete the new designation process that any potential organisation must now go through to become approved to certify medical devices in the UK.
MHRA updates guidance on exporting certain drugs and medicines
On 5th October, the MHRA updated several documents and application forms within its guidance on gaining permission to export certain drugs and medicines.
Industry Updates
FDA approves new treatment option for patients with ALS
On 29th September, the US Food and Drug Administration (FDA) approved Relyvrio to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig’s disease. The FDA granted this application Priority Review designation and it also received orphan drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.
EMA to launch pilot offers enhanced support to academic and non-profit developers of ATMPs
On 29th September, the European Medicines Agency (EMA) announced it will launch a pilot to support the translation of basic research developments into medicines that could make a difference in patients’ lives in the European Economic Area (EEA). The pilot is open to academic sponsors and non-profit organisations that are developing advanced therapy medicinal products (ATMPs). These medicines for human use are based on genes, tissues, or cells and might offer ground-breaking treatment options to patients.
European Commission Decision Reliance Procedure continues to be available until 31st December 2023
On 30th September, the MHRA announced that the European Commission Decision Reliance Procedure has been extended by 12 months to apply across Great Britain until 31st December 2023, to ensure people in the UK continue to have timely access to medicines while MHRA develops proposals for a new international reliance framework.
New recommendations for terlipressin-containing medicines in the treatment of hepatorenal syndrome
On 30th September, the EMA’s safety committee (PRAC) recommended new measures to reduce the risk of respiratory failure and sepsis when using terlipressin-containing medicines in people with type 1 hepatorenal syndrome (HRS-1). The recommendations follow the PRAC’s review of available data, including results from a clinical trial2 involving patients with HRS-1 which suggested that patients who were treated with terlipressin-containing medicines were more likely to experience and die from respiratory disorders within 90 days after the first dose than those who were given a placebo.
EC calls for civil society representatives to participate in the work of EMA’s Paediatric Committee
On 5th October, the European Commission (EC) launched a call for interest to represent patient and healthcare professional organisations in EMA’s Paediatric Committee (PDCO). Three members and alternates from patient organisations and three members and alternates from healthcare professional organisations will be appointed for a three-year mandate starting on 1st August 2023.
Issue Number: WN00081
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