Regulatory in brief | nitrosamines, vitamin D

Regulatory in brief | nitrosamines, vitamin D

10 July 2020 - Deborah Wilkes

Europe takes more action to reduce nitrosamines in medicines, while the UK offers advice on vitamin D and COVID-19.

Action on nitrosamines in medicines

Europe’s Committee for Medicinal Products for Human Use (CHMP) has issued an opinion requiring companies to take measures to “limit the presence of nitrosamines in human medicines as far as possible” and “ensure levels of these impurities do not exceed set limits”.

The European Medicines Agency (EMA) said detailed information for companies, including timelines, would be available soon.

The move would “ensure that nitrosamines are either not present or are present below levels identified to protect public health”, commented the EMA.

“Companies will be required to have appropriate control strategies to prevent or limit the presence of these impurities and, where necessary, improve their manufacturing processes,” added the EMA. “Companies will also have to evaluate the risk of nitrosamines being present in medicines and carry out appropriate tests if a risk is identified.”

The EMA noted that nitrosamines were classified as probable human carcinogens.

The CHMP recently recommended the suspension of all medicines containing ranitidine in the European Union due to the presence of a nitrosamine (click here to read the News story).

Vitamin D and COVID-19

“There is no evidence to support taking vitamin D supplements to specifically prevent or treat COVID-19,” according to the UK’s National Institute for Health and Care Excellence (NICE).

NICE said its rapid evidence summary was based on the “best available evidence on vitamin D for preventing or treating COVID-19, or for the susceptibility to COVID-19 based on vitamin D status”.

However, NICE said “people should continue to follow UK government advice on daily vitamin D supplementation to maintain bone and muscle health during the COVID-19 pandemic”.

NICE, which is part of Public Health England, provides national guidance and advice to improve health and social care.

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