The dialogue has been heating up in the US on the CMC/GMP implications involved in implementing FDASIA’s expedited development and review provisions for breakthrough therapies. The constraints of the current CMC review paradigm are coming into high relief as manufacturing finds itself on the critical path.
The first story in the September Monthly Update focuses on the advice and insights on the breakthrough therapy CMC issues that FDA has provided from the podium and in a draft guidance it has recently issued on expedited approval pathways. Included is an analysis of the BT designations through mid-September.
The story that follows delves into the industry implementation concerns, which center around how the manufacturing development and review process can be adjusted to accommodate the shorter clinical timelines. At issue is what a regulatory approach would look like that would better accommodate manufacturing and control improvements as more knowledge and experience is gained across the product lifecycle.
In the May Monthly Update, IPQ provided an analysis of the challenges FDA faces in implementing the multifaceted supply chain provisions in Title VII of FDASIA and the action plans it had drawn up to meet them (IPQ, May 11). Since then, the agency has been seeking advice from industry and other stakeholders on how to most effectively move down the implementation pathway.
In this issue, IPQ takes a look at the feedback FDA has gotten on the questions it posed in a Federal Register notice and a public meeting in July regarding sections 713 and 714 on assuring the quality of imported drug products and their ingredients. PhRMA and IPEC are among organizations that have been forthcoming on what an effective approach would look like that would not be unnecessarily burdensome – particularly at the border.
A second story on the implementation of the far-reaching provisions of FDASIA focuses on FDA’s release of a draft guidance to flesh out the “circumstances that constitute delaying, denying, limiting or refusing a drug inspection.” The act strengthens FDA’s enforcement clout when inspections are obstructed by being able to designate drugs from the facility involved “adulterated.”
The IPQ coverage includes an analysis of the industry comments that were posted in late September on the draft guidance along with insights from an FDA compliance official provided at the mid-Sept. PDA/FDA conference and a review of the discussions that followed.
On the European regulatory front, EDQM has made some important changes to its CEP submission and revision process for APIs sold in Europe. The IPQ coverage includes an analysis by EDQM management of the CEP program and recent inspection results.
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