In this week’s news, the FDA advises on CMC change reporting, TGA tweaks shortage reporting rules and more…
US FDA issued final guidelines post-approval CMC changes for biologics
The US FDA has issued final guidance for drug firms and CDMOs on CMC post-approval changes for biologic medicines.
The guidance is designed to help manufacturers determine which types of product changes should be submitted to the agency in an annual report and which will require a prior approval supplement.
The guidance applies to changes in the manufacturing process, the drug substance purification process and the starting materials as well as the container and or closure system.
The document applies to vaccines, allergenic products, cell and gene therapy products and plasma-derived products. Blood products and biosimilars are not covered.
TGA tweaks shortage reporting rules
Australia’s Therapeutic Goods Administration (TGA) has updated its guidance on drug shortages after changing its online reporting database.
Under the rules firms that supply drugs to Australia are required to notify the agency of shortages through the database. Details of all shortages and discontinuations are published on the Medicine Shortage Reports Database part of the TGA website.
Chinese regulators want feedback on drug traceability specs
The Chinese National Medical Products Administration has called for industry input on plans to establish a drug information traceability system in the country.
According to a note on its website (here in Mandarin with translations available) the agency wants input coding to be used for the traceability system.
Also in the news
Inside Health Policy covered the FDA’s new Generic Drug Cluster through which the agency says it will address generic drug development and increase scientific alignment.
The Pink Sheet reported that US FDA inspection work could be back to normal by the summer.
The Washington Post looked at Pfizer’s efforts to increase production of its co-developed COVID-19 vaccine.
Politico reported the FDA has ordered Johnson & Johnson to scrap 60 million doses of its Covid-19 vaccine made at Emergent’s facility in Baltimore.
RAPS looked at plans to change how the US FDA regulates medical devices.
Endpoints looked at regulators efforts to harmonize drug reviews.
Some developments of note in the contracting sector:
The pandemic has increased demand for CDMOs according to a report by CPhI online.
Eye disease gene therapy developer Ocugen has hired Jubilant HollisterStier to make its vaccine candidate Covaxin for the US and Canadian markets.
Samsung Biologics has plans to go beyond being a services firm according to a report by Bioprocess Insider.
CDMO investment promoted by COVID-19 will benefit the wider pharmaceutical and contracting sectors according to a report in Bioprocess International.
Dendreon Pharmaceuticals has announced plans to build its CDMO business. The cell therapy firm cited growing demand for production capacity for late stage product candidates.
Danaher will buy acquire DNA, mRNA and protein supply firm Aldevron, for $9.6 billion. See press release.
Yposkesi is constructing a second commercial cell and gene therapy facility at a site in Corbeil-Essonnes, near Paris, France. The announcement comes months after SK Pharmteco became a majority equity shareholder.