Stringent excipient rules come into effect in China; new penalties for both drug and excipient makers
This article was originally published in SRA
New provisions for improving the supervision of pharmaceutical excipients in China that became effective on 1 February are the most stringent regulations of their kind and are likely to cause considerable debate within the pharmaceutical industry, according to law firm CMS1,2.
You may also be interested in...
The International Pharmaceutical Regulators Programme has documented various approaches currently being used for the clinical comparability of biosimilar monoclonal antibodies in different jurisdictions.
Remote inspections are here to stay, and global regulators are aligning efforts to develop consensus on how these should be conducted.
Device companies operating in Canada are being advised to review their internal procedures in anticipation of new postmarket requirements that come into force this year.