The European Commission posted a draft legislative framework for regulation of artificial intelligence (AI), a document that spans all potential uses of such algorithms rather than just medical ones. The text seems to suggest that all medical uses of AI will be deemed high-risk uses, but this draft is just the opening salvo in a process that will span a year, perhaps longer, before the legislation will be drafted and finalized.
To encourage more innovative medical devices to enter the market faster, China has revised its regulation to allow third parties to manufacture devices, foreign devices that are not yet approved overseas to be imported to the country, and to shorten the regulatory process. The new regulation will take effect on June 1. The 2021 version of the Regulation on Supervision and Administration of Medical Devices introduced a few important changes, echoing Beijing’s call to spur health care innovation. The last update was in 2014.
HONG KONG – Celltrion Inc. has received the European CE mark for Tekitrust, its COVID-19 tests kit developed with Mico Biomed Co. Ltd. “Mico, which is a diagnostic device specialist, partnered with Celltrion to combine both companies’ strengths in the test kit sector,” a Celltrion spokesperson told BioWorld. Mico will manufacture the kits, while Celltrion handles marketing and sales.
Now drugmakers can gain instant access to hospitals in Hainan province right after their innovative drugs are approved by China’s National Medical Products Administration to skip market entry hurdles.
Suzhou-China based Cstone Pharmaceuticals Co. Ltd., which in-licensed RET inhibitor pralsetinib from Blueprint Medicines Corp. in 2018, has won Chinese approval for the drug to treat adult patients with locally advanced or metastatic RET fusion-positive non-small-cell lung cancer after platinum-based chemotherapy. Already approved as Gavreto in the U.S., the drug is Cstone’s first product approved in China and the country’s first selective RET inhibitor.
HONG KONG – Eisai Co. Ltd. has received not one, but two approvals from Japan’s Ministry of Health, Labour and Welfare (MHLW), for its anticancer agent Remitoro (denileukin diftitox) and multiple receptor tyrosine kinase inhibitor Lenvima (lenvatinib mesylate).
China’s National Medical Products Administration granted conditional approval two Chinese-developed COVID-19 vaccines in less than 24 hours on Feb. 25. One of the vaccines approved was developed by Tianjin-based Cansino Biologics Inc., and the other by China National Pharmaceutical Group (Sinopharm) through its Wuhan Institute of Biological Products subsidiary.
PERTH, Australia – Australia’s Therapeutic Goods Administration is proposing changes to its fees and charges and is asking stakeholders for feedback on three different proposed fee structures for the 2021-2022 financial year.
Although FDA approvals in 2020 are falling just shy of records, the amount of regulatory news this year is more than twice the amount seen only four years ago and a 41% increase over that reported in 2019. The COVID-19 pandemic accounts for roughly 14% of the total, but regardless, by all accounts, 2020 has been an excessively busy year for both the biopharma industry and regulatory agencies.
DUBLIN – The European Medicines Agency’s human medicines committee, the CHMP, all but closed out the year by issuing positive opinions on eight marketing authorization applications during its December meeting. Its work for 2020 is not quite yet done, however. It has scheduled an extraordinary meeting for Dec. 29 to review an application from Pfizer Inc. and Biontech AG for their mRNA COVID-19 vaccine BNT162b2.
