The Monthly Update for May begins with an analysis of the excipient DMF-based regulatory process in the US and the discussions that flowed at an IPEC workshop on where the problems lie and what firms can do to address them. Included are insights from a CDER official involved in DMF management.
A second story takes a look at the IPEC workshop discussions of the evolving excipient regulatory picture globally, with a focus on developments in China and India in particular.
Another of the stories takes a look at FDA’s compliance/enforcement data transparency initiative, the impact it has already had, what its working groups are now planning to accomplish, and why it is high on the agency’s agenda.
FDA has been putting a lot of thought into how to improve the targeting of its inspection resources at firms, processes, and products that pose the greatest health risks. MHRA is also working on sharpening its regulatory intelligence gathering and communication processes to get a better handle on where compliance and drug shortage risks are located before they manifest themselves and to maximize inspection effectiveness. The IPQ coverage in the May Monthly Update takes a look at the UK agency’s initiative, with the help of insights from the MHRA inspection official directing it.
The regulatory constraints to post-approval manufacturing change – the perennial elephant in the room in any conversation about continuous improvement – is a concern that remains squarely in IPQ’s sights. The final story in the Update analyzes the latest efforts in the US and Europe to address the problem by finalizing guidances this spring aimed at clarifying where and how CMC change preclearance obstacles can be avoided.
The in-depth stories in the issue are accompanied by about 30 “updates in brief.” IPQ’s briefs include links to related IPQ coverage and to the documents referenced, and are intended to keep its subscribers informed on all of the significant developments in drug and biologics quality regulation worldwide as they are occurring.
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