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China’s Food and Drug Administration has proposed a regulation that would require excipient suppliers to disclose information that is above and beyond what is needed to demonstrate safety of pharmaceutical ingredients and that poses considerable IP risk to excipient suppliers, industry official says.
Performance-Based Conditions Could Ease Post-Approval Changes For Process Analytical Technologies, Experts Say
Pharmaceutical industry officials are promoting the idea of “marrying” the concepts of performance-based approaches and process analytical technology in the draft ICH Q12 guideline. Embedding this idea in ICH Q12 would give industry more flexibility in managing post-approval changes and aligns with the guideline’s concept of lifecycle improvement.
Latest From Manufacturing
EU Proposal To Restrict Microplastics In Pharmaceutical Ingredients Has US Excipient Industry On Edge
A proposal by the European Chemicals Agency that would restrict the use of microplastics in pharmaceuticals in the EU under its REACH regulation has come under attack by the US excipient industry. Officials argue that the proposal is misguided in that it considers all polymers to be microplastics and would unnecessarily restrict the availability of medicines that contain polymers in formulations.
There is growing recognition that the US FDA can use trade agreements to help confront the challenges of globalization and that these agreements can play an increasingly important role in fostering regulatory alignment and improving the quality of imports, agency official says.
The poorest-quality pharmaceuticals consumed in the US are the ones FDA has never reviewed, or are from sites the agency has never inspected, regardless of country of origin; the agency’s inaugural ‘State of Quality’ report contains some surprising findings.
Of the 60 or so applications the European Medicine Agency has received from drug companies hoping for more time to move their batch testing sites from the UK to the EU, about 50 have been successful.
A US FDA official has announced that major revisions are underway to address problems with the agency’s Inactive Ingredient Database. These include replacing potency limits with a maximum daily exposure limit and adopting standard terminology for routes of administration. In its current form, the IID has been a source of confusion for industry.
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