In this week’s news, UK restricts drug exports over shortages, EMA calls for nitrosamine testing, Trump predicts drug imports and more…
UK restricts HRT exportation over shortage concerns
The UK has restricted the export of certain medicines citing concerns about potential shortages.
The Department of Health and Social Care announced the move last week, explaining it was designed to prevent wholesalers from selling drugs intended for the UK elsewhere.
It wrote, “Nineteen HRT drugs will be subject to export restrictions to ensure that alternatives remain available for the HRT drugs that are in short supply. Similar measures are in place in other European countries, including France and Spain.”
The DHSC did not provide additional information on the cause of the shortages.
The DHSC also said it would restrict the exportation of a further five medicines, including all adrenaline auto-injectors and hepatitis B vaccines. The full list is available here.
In a separate letter, the UK agency warned wholesalers against “hoarding” medicines that are in short supply, suggesting those which do may face regulatory action.
HRT manufacturing issues
In September the British Menopause Society published details of several manufacturers it says are experiencing supply issues with HRT products.
In response to the export restriction the society said it “welcomes the Government’s new measures that restrict exporting hormone replacement therapy (HRT) outside the UK.
“These measures are likely to benefit many women affected by the ongoing HRT manufacturing and supply shortages.”
US FDA aims to help industry with biologic drug submissions
The US FDA has published templates to help developers submit information on the bioanalytical methods used for pharmacokinetic assessment.
The Agency shared the templates last week. It wrote that “the templates in this guidance are applicable to bioanalytical procedures such as chromatographic assays (CCs) and ligand-binding assays (LBAs).
It said such methods are used in clinical trials to determine “the levels of drugs and their metabolites and therapeutic proteins in biological matrices such as blood, serum, plasma, urine, and tissue such as skin.”
EMA urges pharma to test for nitrosamines
The European Medicines Agency has asked firms to check their products for nitrosamines, which are compounds linked to increased cancer risk.
The Amsterdam-based regulator issued the call to action last week, urging manufacturers that detect the carcinogens to notify it immediately.
It wrote that, “Although nitrosamines are not expected to form during the manufacture of the vast majority of medicines containing chemically synthesised active substances, it is important that all companies who have not already done so take appropriate precautionary measures, if necessary, in line with recommendations from the recently concluded review of sartans.”
Also in the news
RAPS reported US President Donald Trump’s suggestion the country is to start large scale importation of drugs.
STAT spoke with a US doctor about the risks posed by drug shortages. The piece focuses on the bladder cancer drug BCG, which is now only made by one supplier.
DCAT reported on the pharmaceutical industry’s effort to prepare for Brexit. Withdrawal from the EU in any form will impact drug supplies according to the publication, which points out that around 7,000 of the 12,300 medicines used in the UK are imported.
Some developments of note in the contract manufacturing sector.
The US FDA has given US contractor Lyophilization Services of New England (LSNE) the green light to make a sterile injectable product at a facility in León, Spain. LSNE bought the plant in June. See press release.
Thermo Fisher Scientific has bought an API manufacturing site in Cork, Ireland from GSK. The facility, acquired for €90m, will become part of Thermo’s Pharma Services business within its lab products and services Segment. See press release.
Trakcel has teamed with Wuxi Apptec to develop an “end-to-end” system for the handling of cell therapies. See press release.