Tower Mains Weekly Newsletter
We are also delighted to announce that our Head of Quality Assurance, Shona Ross and Head of Quality Management, Cate Ovington, will be participating at the RQA European QA Symposium this week! Also representing Tower Mains will be Marina Freiberga, who is now with Simbec-Orion.
MHRA seeks views on reclassification of pain medication
On 13th May 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) announced it was consulting on making Nuromol, a medicine that contains ibuprofen and paracetamol, available without the need to visit a pharmacy. The public has until 3rd June to respond to the consultation on the potential reclassification of the medicine to a general sale list medicine.
MHRA publishes weekly report covering adverse reactions to approved COVID-19 vaccines
On 13th May 2021, the MHRA published a weekly report covering adverse reactions to approved COVID-19 vaccines. The MHRA operates the Yellow Card scheme on behalf of the Commission on Human Medicines (CHM). The scheme collects and monitors information on suspected safety concerns or incidents involving vaccines, medicines, medical devices, and e-cigarettes.
EMA issues highlights from its Committee for Medicinal Products for Veterinary Use (CVMP)
On 17th May 2021, the European Medicines Agency (EMA) issued meeting highlights from its Committee for Medicinal Products for Veterinary Use (CVMP) on the 10th-12th May 2021. Highlights include the conclusion of the referral procedure for injectable veterinary medicinal products containing vitamin A for use in food-producing species and joint EMA/CMDv guidance on the details of the classification of variations requiring assessment according to Article 62 of Regulation (EU) 2019/6 for veterinary medicinal products.
European Commission launches public consultation on European Health Data Space (EHDS)
The European Commission has launched a public consultation on European Health Data Space (EHDS), which aims to make full use of digital health to provide high-quality healthcare and reduce inequalities. It will promote access to health data for prevention, diagnosis and treatment, research and innovation, as well as for policymaking and legislation.
EMA recommends a change to the approved storage conditions of Pfizer-BioNTech COVID-19 vaccine
On 17th May 2021, the EMA’s human medicines committee (CHMP) recommended a change to the approved storage conditions of Comirnaty, the COVID-19 vaccine developed by BioNTech and Pfizer, that will facilitate the handling of the vaccine in vaccination centres across the European Union. This change extends the approved storage period of the unopened thawed vial at 2-8°C (i.e. in a normal fridge after taking out of deep-freeze conditions) from five days to one month (31 days).
FDA authorises change to storage conditions of thawed Pfizer-BioNTech COVID-19 vaccine prior to dilution
On 19th May 2021, the U.S. Food and Drug Administration (FDA) announced it had authorised a longer time for refrigerator storage of thawed vials of Pfizer-BioNTech COVID-19 vaccine prior to dilution. This change should make this vaccine more widely available.
FDA advises against use of SARS-CoV-2 antibody test results to evaluate immunity or protection from COVID-19
On 19th May 2021, the FDA announced it was advising against the use of SARS-CoV-2 antibody test results to evaluate immunity or protection from COVID-19, including after vaccination. The FDA will continue to monitor the use of authorized SARS-CoV-2 antibody tests for purposes other than identifying people with an adaptive immune response to SARS-CoV-2 from a recent or prior infection.
Issue Number: WN00011