In this week’s news, EC urges pharma to shift UK batch testing, US wants drugs from Canada, Swissmedic preps for IT rejig, and more…
EC urges Pharmas with UK batch testing ops to relocate them before Brexit
The European Commission has reminded firms that batch test in the UK they will need to move them to the EU if Brexit goes ahead on October 31.
The Commission made the comments last week. It said marketing authorisation holders (MAHs) need to ensure all UK-based batch testing is transferred to EU facilities by 1 January 2020.
It also made clear drug companies can request an extension as long as they have identified a new EU batch release site before Brexit.
Firms seeking an extension will also need to have UK batch operations supervised by an EU-based qualified person.
In February the EC said that companies wanting to sell drugs in the EU need to conduct batch testing operations in a member state.
In the latest communique, the Commission said “It is essential that marketing authorisation holders use the remaining time to complete their preparations so that by 1 January 2020 all batch testing facilities are fully transferred to the EU27/EEA and the necessary regulatory submissions are completed.”
US wants to import meds to combat high prices
The US Department of Health and Human Services (HHS) has outlined how patients can import drugs.
The HHS advice follows President Donald Trump’s suggestion people should consider buying medicines outside the US to save money.
The plan – part of Trump’s focus on drug prices – has not been well received in Canada according to Bloomberg.
Industry and US FDA team to foster biopharma innovation
The US National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) has teamed-up with the FDA to strengthen research, innovation, training, and collaboration in biopharma.
Acting FDA Commissioner Ned Sharpless said the project will involve developing improves manufacturing methods and technologies, citing demand.
“We are increasingly seeing the potential for advanced manufacturing innovations that can improve drug quality, help address shortages of medicines, speed time-to-market, and support personalised medicine through technologies including 3D printing and continuous manufacturing.”
NIIMBL said the collaboration will allow it to “support investments in regulatory science research and training needed to foster advanced manufacturing innovations.”
It cited areas like continuous and on-demand manufacturing as well as advanced process control tech as examples of areas covered by the accord.
Swissmedic preps to update access system for drug firms
Swissmedic has asked drug companies to delete accounts they do not need from its system by August 23.
The Swiss drug regulator made the request last week, explaining the aim is to prevent the unnecessary migration of data to its new management system.
Swissmedic says the new system – known as the E-Government Identity and Access Management (eIAM) environment – will simplify operations and improve security for users. It is due to come online next month.
Read the Swissmedic announcement.
Also in the news
GEN looked at single use bioprocessing technology recycling.
Thermo Fisher told Bioprocess Insider pharma M&A are good for business.
RAPS outlined the US FDA’s new user fees for pharmaceutical companies.
Also RAPS looked at what drug companies can do to ensure they have a successful interaction with an FDA advisory committee.
Some developments of note in the contract development and manufacturing sector.
Lonza will make Omeros’ candidate transplant injury treatment narsoplimab for trials and commercial supply.
The US drug firm is preparing to file the monoclonal antibody based drug in the US and EU.
Fujifilm Diosynth Biotechnologies has completed the acquisition of Biogen’s manufacturing facility in Copenhagen, Denmark. Fujifilm paid $890m for the plant, which has been used for the production of biologics for trials and commercial supply.
Samsung Biologics will make more of UCB’s candidate supranuclear palsy treatment. The drug will be the third UCB product made by Samsung under a 2018 manufacturing deal.