In this week’s news, US FDA moves to secure drug supply chains with new guidance documents, EMA calls for feedback on electronic drug ID plan and more…
US FDA advises on product IDs and suspect shipments
The US FDA has issued new guidance documents that it says will help the pharmaceutical industry secure drug supply chains.
Donald Ashley, Director of the Office of Compliance for FDA’s Center for Drug Evaluation and Research, said, “Ensuring the quality of prescription drugs and safeguarding the integrity of pharmaceutical distribution are crucial roles the FDA plays in protecting the health of the American public. Illegitimate and unsafe products must be kept out of the U.S. drug supply chain.
Ashley added, “We are issuing guidance documents intended to assist trading partners in complying with the law and achieving a safer, more secure and more trusted drug supply chain.” He also asked for feedback from industry.
EMA wants feedback on electronic product ID plan
The EMA has asked for industry feedback on plans for new standards for electronic product information (ePI) drugs.
The Amsterdam-based regulator asked for input this week. It said that the plan is to provide a semi-structured template for ePI incorporating product information, including its characteristics, labelling and package leaflet.
The agency said EMA the template will make for easier “electronic handling and allows dissemination via the web, e-platforms and print.”
The EMA intends to hold virtual workshops to share details of the standard and to collect feedback that will be used to ensure the standard meets the needs of its future users.
Also in the news
The US Government has moved to block drug industry efforts to impede imports from Canada according to STAT.
US FDA inspection activities are expected to return to normal next year however, the agency faces a significant backlog of audits according to a report by the PinkSheet.
GEN looked at the impact of the pandemic on CDMOs, finding that already stretched capacity has been pushed to the limit.
The New York Times reported that AstraZeneca is in talks to find a replacement CDMO for Emergent Biosciences in light of recent problems during the manufacture of its COVID-19 vaccine.
Outsourced-pharma examined opportunities for the contract manufacturing sector in a report published this week.
Some developments of note in the contracting sector:
Jubilant HollisterStier will invest $92 million to expand sterile injectable manufacturing capacity at its site in Spokane, WA. This firm said it will set up a high-speed 400 vials a minute injectable fill line with isolator technology, which will enhance capacity by 50%.
Also in Spokane, Selkirk Pharma has started building a facility at which it will provide fill and finish services for injectable drugs, including vaccines and biological therapeutics.
Sharp has acquired land next to its site in Conshohocken, PA as part of a $17 million investment programme.
Recro Pharma has expanded its clinical trial offering adding clinical-scale sachet and blister packaging for trial pharmaceuticals.