China’s National Medical Products Administration is grappling with how to regulate drugs that are sold online as it issued new provisions under the country’s Drug Administration Law that allows prescription drugs to be sold online for the first time.
Citing efforts to “encourage innovation,” China’s National Healthcare Security Administration included 111 new drugs in its National Reimbursement Drug List (NRDL). The adjustment, shared Jan. 18, 2023, also removed three drugs, leaving the latest NRDL with a total of 2,967 drugs. Most of the newly added drugs are recently approved drugs, with many making it to the market in the last five years. Twenty-three were approved in 2022.
The Australian government has begun its closely watched independent review of the health technology assessment (HTA) process in the country, and it delivered a first peek at what it will consider. This independent review of the HTA system is the first of its kind in nearly 30 years.
The U.S. FDA has lifted the clinical hold on Astellas Pharma Inc.’s Fortis phase I/II trial evaluating AAV gene replacement therapy AT-845 in adults with late-onset Pompe disease.
India’s drug regulatory system is under the lens again after the World Health Organization’s (WHO) latest medical product alert on two substandard cough syrups manufactured in the country.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbisko, Alpha, Eisai, Escient, Huidagene, Junshi, Moderna, Nanoscope, Novelmed, Regeneron, Sandoz, Sanofi, Xeris, Zai.
The U.S. FDA has posted or updated several recalls in the second half of January 2023, such as the class I recall of Mahurkar hemodialysis catheters distributed by Medtronic plc., reported Jan. 30. This recall is associated with two injuries but no fatalities to date, but the potential for mixing of venous and arterial blood has forced Medtronic to request that its customers quarantine any unused catheter kits, which could be a substantial amount of product given the nearly 23,000 units are affected by the recall.
The advantage of the U.S. FDA’s effort to regulate artificial intelligence (AI) in medical devices is that it is specific to medical devices and other medical products, but this vertical approach to AI regulation might soon become exceptionally complicated thanks to a new AI risk management framework posted by the U.S. National Institute for Standards and Technology (NIST). The NIST guideline is agnostic to the sector of the economy and thus may carry with it the expectation that developers of software as a medical device will hew to both the NIST framework and FDA regulations, a layering of requirements that could vastly complicate the task of developing and deploying these algorithms.
A Jan. 27 settlement the U.S. SEC reached with a former vice president at a biotech company serves as a reminder that insider trading rules applies to suppliers as well as the companies involved in an M&A.
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