Tower Mains Weekly Newsletter
We are delighted to welcome Greta Čepanonyté to the Tower Mains team as QA Associate. Greta will be providing support to clients and staff in the form of audit and advice mainly in the areas of GLP, GMP and ISO 17025.
EMA issues highlights from its Committee for Medicinal Products for Human Use (CHMP)
On 21st May 2021, the European Medicines Agency (EMA) issued meeting highlights from its Committee for Medicinal Products for Human Use (CHMP) on the 17th-20th May 2021. Highlights include the approval of eight new medicines, including one for gene therapy, and the recommendation to renew the conditional marketing authorisation for Veklury (remdesivir), the only authorised antiviral treatment for COVID-19.
EMA issues additional advice on Vaxzevria (formerly COVID-19 Vaccine AstraZeneca)
On 21st May 2021, the EMA provided additional advice on blood clots or low blood platelets occurring after vaccination with Vaxzevria (formerly COVID-19 Vaccine AstraZeneca). The updated EMA recommendations are available in the vaccine’s product information. As for all vaccines, EMA and national authorities continuously monitor the safety of Vaxzevria and will update recommendations when necessary, to protect public health.
EMA issues advice on the use of sotrovimab (VIR-7831) for treating COVID-19
On 21st May 2021, the EMA issued advice on the use of sotrovimab (VIR-7831) for treating COVID-19. It was concluded that it can be used to treat confirmed COVID-19 in adults and adolescents (aged 12 years and above and weighing at least 40 kg) who do not require supplemental oxygen therapy and who are at risk of progressing to severe COVID-19. While the current evaluation has concluded, a rolling review of sotrovimab, which started on 7th May, is ongoing.
AstraZeneca COVID-19 vaccine Vaxzevria authorised for emergency use in Japan
On 21st May 2021, it was announced that AstraZeneca COVID-19 vaccine Vaxzevria has been granted a special approval for emergency use in Japan for active immunisation of individuals aged 18 years and older, to prevent COVID-19. The Japanese Ministry of Health, Labour and Welfare granted the approval based on positive Phase III efficacy and safety data from the Oxford University-led clinical trial programme in the UK, Brazil and South Africa, and a Phase I/II trial in Japan.
MHRA updates guidance on how to notify the MHRA about a clinical investigation for a medical device
On 25th May 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance on how to notify it of the intention to carry out a clinical investigation for medical devices. The guidance is being updated due to the EU Medical Device Regulation (MDR) coming into effect in Northern Ireland from 26th May 2021.
MHRA updates guidance on how tests and testing kits for coronavirus (COVID-19) work
On 25th May 2021, the MHRA updated its guidance on the different types of tests and testing kits for COVID-19, and the specifications for manufacturers. A section has been added on testing for international travel: ‘For patients, the public and professional users: a guide to COVID-19 tests and testing kits’.
MHRA publishes its 2020 report on the regulation of medicines advertising to promote transparency.
On 25th May 2021, the MHRA published its annual corporate report on the regulation of medicines advertising.
FDA updates its guidance on Emergency Use Authorisation (EUA) for COVID-19 vaccines
On 25th May 2021, the U.S. Food and Drug Administration (FDA) updated its guidance on Emergency Use Authorisation (EUA) for COVID-19 vaccines. A new section was added to clarify how the agency intends to prioritise the review of EUA requests for the remainder of the COVID-19 public health emergency. The document supersedes the guidance of the same title issued on 22nd February 2021.
FDA authorises additional monoclonal antibody for treatment of COVID-19
On 26th May 2021, the FDA issued an emergency use authorisation (EUA) for the investigational monoclonal antibody therapy sotrovimab for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to severe COVID-19, including hospitalisation or death. The safety and effectiveness of this investigational therapy continues to be evaluated for treatment of COVID-19.
Medical Device Regulation comes into application
On 26th May 2021, the regulation (EU) 2017/745 on medical devices became applicable. The Medical Device Regulation (MDR), which was adopted in April 2017, changes the European legal framework for medical devices and introduces new principal and supportive responsibilities for EMA and for national competent authorities in the assessment of certain categories of products. The Regulation entered into force in May 2017 and had a staggered transitional period.
Issue Number: WN00012