- Last month the Thai FDA promulgated that the medical device application pre-screening time would be reduced from 30 days to 1 day. In addition, the time to review Class 2-4 device applications would decrease from 200 days to 120 days if an expert review was not needed. If an expert review was needed, the time to review would be decreased from 250 days to 150 days. Registration review timeline changes are anticipated to be put in force by the end of the first quarter of 2024.
- In late December, China’s National Healthcare Security Administration (NHSA) made an announcement to deal with price differences in different provinces. A countrywide procurement information platform will soon be established to provide China’s provinces with prices of specific drugs so a more uniform system can exist. Sichuan and Hunan provinces have already implemented price caps to align with prices in other provinces.
- Last week, Indian government officials and US officials met to deal with medical trade issues. Both sides agreed to try and work in a more cooperative manner on a number of issues like dealing with pricing and standards for some medical devices like orthopedic implants and cardio stents. Also discussed was the world’s reliance on APIs for drugs and what could be done to ease this burden and risk. Finally, India has agreed that the US should have more FDA audits to help guarantee the drugs and drug substances exported to the US are properly safeguarded. These talks are especially important as a result of US – China geopolitical tensions.
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Ames Gross
President
Pacific Bridge Medical
Bethesda, MD
www.pacificbridgemedical.comcontact@pacificbridgemedical.com------------------------------