In this week’s news, EU-US MRA reaches full implementation, API repackers in spotlight in US, new REMS guidance tweaks and more…
EU and US data sharing programme in full swing
The EMA’s mutual recognition agreement with the US FDA has been fully implemented after Slovakian regulators were deemed to be up to standard.
The mutual recognition deal – under which EU member states can access FDA facility inspection data and vice versa – went into full effect last week according to a joint announcement.
Guido Rasi, EMA executive director, said, “Authorities on both sides of the Atlantic will now be able to rely on each other’s inspection results.
“It will support making best use of our inspection capacity, so that patients can rely on the quality, safety and efficacy of all medicines, no matter where they have been manufactured.”
As well as reducing the number of inspections manufacturers undergo – and allowing regulators to make best use of resources – the MRA means that drug firms can stop import testing for products made in the US.
In addition, according to the FDA, “Currently, the MRA is being applied to surveillance inspections conducted only within our respective borders. However, the U.S. and the EU have the option of relying on inspection reports for manufacturing facilities located outside each other’s territories.”
US FDA crackdown on drug ingredient repackers
The US FDA has warned three firms involved in repacking active pharmaceutical ingredients (APIs) for violating current good manufacturing practices (cGMP).
The agency shared details of its warning letters in a notice last week, writing that the firms involved could be putting consumers at risk.
API repackers take bulk API place it into a different container without further manipulation distribute it to drug manufacturers, compounding pharmacies or outsourcing facilities. Improper repackaging can cause serious vulnerabilities in the supply chain the agency says.
Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, used the note to stress the vital role API repackers play in the US pharmaceutical supply chain.
“The U.S. drug supply chain remains one of the safest in the world, yet because of the various players and increased globalization, it has become increasingly complex.
“The FDA remains vigilant in our inspections and oversight of the supply chain and as part of this effort, we inspect API repackers to help identify and prevent any weaknesses in the legitimate supply chain – this is especially important within the context of the opioid crisis for those who handle opioids.”
New FDA guidance documents
In other news, the US FDA has issued an important new draft guidance document.
It focuses on risk evaluations and mitigation strategies – or REMS – which are used for drug products where the risk/benefit ratio is finely balanced.
According to an FDA statement issued last Sunday, the guidance covers changes to approved REMS strategies, how application holders should submit changes, and how the FDA will process submissions.
The agency asked for comment.
Also in the news
The number of enforcement actions implemented by the US Food and Drug Administration have fallen under the current administration according to Science.
Health Affairs looked at ongoing efforts to “rebalanced” drug prices without impacting developers R&D efforts.
Developments of note in the CDMO space:
Brammer Bio, part of Thermo Fisher Scientific, has signed a development and manufacturing deal with Amicus Therapeutics. The focus will be the latter portfolio of Batten’s disease gene therapies.
Passage Bio has established a gene therapy manufacturing suite at Maryland facility operated by Catalent Biologics’ unit, Paragon Gene Therapy.
The US National Institute of Allergy and Infectious Diseases (NIAID) has contracted IDT Biologika to make five E. coli Master Cell Banks. The banks will be used to develop vaccines.