In this week’s news, FDA advocates risk-based plant strategy, EMA offers help to antibioitc firms, and more…
US FDA says modernisation better for patients and industry
The FDA says its risk-based approach to facility inspections has increased public confidence in the quality of drugs sold in the US.
Melinda Plaisier, Associate Commissioner for Regulatory Affairs, made the comments in a blog post last week. She explained a project called Program Alignment had seen the agency modernise its processes.
“The FDA prioritises inspections of sites regardless of their location and through this model we have achieved parity of inspections.
“Depending on the risk-based assignments, FDA may now do more foreign inspections than domestic — and both are of the same scope and intensity.”
The US regulator shared details of how it prioritises facility inspections last year. Making the document public has helped pharma companies and CDMOs according to Plaisier.
“Our policy explains how a facility’s compliance history, recall trends, time since last inspection, inherent risk of the drug being manufactured, processing complexity and other factors are all weighed and considered.”
… helps resources go further
More efficient facility inspections are also vital for the FDA. According new data, the agency carried out 1,365 cGMP inspections in 2018, 739 of which were outside the US.
Pharmaceutical plant inspections are a resource intensive activity. FDA modernisation efforts are also designed to let the agency make best use of resources says Plaisier.
“The globalisation of the manufacturing industry and supply chain is simply huge, and no one inspectorate can inspect it all. Wherever possible, inspectorates need to share information and discuss respective regulatory decisions so that global partners can learn from each other.”
She cited the Mutual Recognition deal with the EU and the FDA’s membership of the PIC/S as examples.
Read the full blog post here.
EMA commits to working with pharma to fight superbugs
The European Medicines Agency (EMA) innovation task force (ITF) can now help drug firms developing antibiotics.
The agency announced the ITF will accept requests for help from antibiotic developers last week. Previously, the task-force only helped developers of innovative drugs.
However, the EMA said the threat of antibacterial resistance had prompted the change.
The move is part of an agency effort to address antibacterial resistance.
“Stimulating the development of new medicines to treat resistant bacterial or fungal infections is one pillar in the fight against this threat, and a high priority for EMA and the European medicines regulatory network.
Read more here.
Also in the news
Adoption of continuous manufacturing is speeding up thanks to novel drugs according to Chemical and Engineering News.
The Association for Accessible Medicines stressed the importance of a robust biosimilars industry. It said such products help governments cut healthcare spending.
The New York Times says pharma execs blamed for opioid crisis could face prosecution under laws that target Racketeer Influenced and Corrupt Organizations (RICO).
Nearly half of all drugs approved last year relied on efficacy data from a single trial according to RAPS.
Developments in the CDMO space
Catalent has completed the acquisition of gene therapy manufacturing specialist Paragon Bioservices.
Thermo Fisher says it will spend $50m to expand biologics production capacity.
China-based Wuxi Biologics has hired Jacobs to build a biologics plant in Ireland.