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HONG KONG – China's drug authority is upscaling the Marketing Authorization Holder (MAH) mechanism pilot, which is seen as a boon for drug innovation in the country.

While President Donald Trump's signature on the FDA Reauthorization Act (FDARA) Friday put to rest any lingering fears about potential layoffs at the FDA come Oct. 1, it also paved the way for the next congressional showdown – one that could still shutter parts of the FDA and other federal agencies.

HONG KONG – Chinese regulators have clarified the legal consequences of data falsification in new drug and medical device applications, alarming the industry – both applicants for registration and research institutions – by raising falsification to the level of a criminal law violation.

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