In this week’s news, EMA sets up anti-shortage plan, US FDA relaxes compounding rules, MHRA takes pharma homeworking on board and more…
EMA sets up Covid-19 related drug shortage monitoring system
The EMA has set up a new drug supply monitoring system designed to prevent supply issues for drugs used to treat patients with Covid-19.
The Amsterdam-based agency launched the fast track monitoring system – called i-SPOC –last week. The plan is drug companies appoint a contact point to notify the EMA of current and anticipated shortages of medicines used in patients with COVID-19.
The EMA said, “The new mechanism will allow better oversight of ongoing supply issues and a quicker flow of information between regulatory authorities in the EU and the pharmaceutical industry with the objective of mitigating and preventing shortages of medicines used during the COVID-19 health emergency.”
Initially reporting will focus on a subset of medicines used in the treatment of COVID-19 patients in hospital intensive care units (ICUs) such as anaesthetics, antibiotics, resuscitation drugs and muscle relaxants.
In time reporting will be required for a broader range of drugs.
US FDA issues guidance for compounders during pandemic
The US FDA has published a temporary policy for compounders making certain drugs during the Covid-19 pandemic. There are separate guidance documents for compounders registered as outsourcing facilities as well as smaller operations. The aim is to make it more straightforward for compounders to compound certain drugs used to treat patients on ventilators.
The FDA wrote “In order to respond to evolving regional conditions, additional flexibility is temporarily needed to ensure that treatment options are available when hospitals are unable to obtain FDA-approved drugs used for hospitalized patients with COVID-19.
“Therefore, as a temporary measure during the public health emergency related to COVID-19, or until FDA otherwise withdraws or revises this guidance, FDA does not intend to take action against an outsourcing facility for compounding a drug product that is essentially a copy of an approved drug.”
MHRA sets out how drug firms can approve GxP docs at distance
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has told drug firms how they can approve GDP documents remotely. The regulator wrote, “Due to the COVID-19 pandemic, remote working has increased. Some organisations have advised that their processes for approving paper documents with wet ink signatures are no longer achievable.”
Also in the news
Legislation will shape the Chinese CDMO sector according to a report by CPhI Online.
Inside Health Policy predicts an increase in legal action as a result of the Covid-19 pandemic’s impact on supply chains.
Lachman Consultants took a look at generic drug review by the US FDA in recent years.
Sanofi and GSK will employ tech used to make Flublok and as03 adjuvant technology to develop a coronavirus vaccine. Read the full Bioprocess Insider report.
The US FDA, EMA and 16 drug firms have teamed up to develop vaccines for SAR-CoV-2 and treatments for COVID-19 according to the US NIH.
Some developments of note in the contract services space.
Sharp Clinical announced it is involved in six clinical trials related to COVID-19.
Alcami shared details of its involvement in Eagle Pharmaceuticals’ Ryanodex (dantrolene sodium), which is being tested against SARS-CoV-2, the virus that causes COVID-19.
Vir Biotechnology has hired Samsung Biologics to make its candidate SARS-CoV-2 monoclonal antibody.
Seikagaku has acquired Dalton Pharma Services. Read more details at Contract Pharma.