Maybe we don't need FDA/EMA approval to get a green light in China?
posted on
Aug 11, 2018 12:03AM
I read an article recently about the possibility of China green lighting drugs ahead of FDA/EMA approval....this isn't the article I read but, by my understanding, its saying the same thing.
https://www.fdanews.com/IPRM0325162
Here's part with me bolding areas where Apabetalone may fit imo:
China’s FDA is creating a fast lane-approval pathway to speed certain categories of drugs to market.
In a Feb. 26 notice, the agency outlined plans to implement a priority review pathway for novel drugs that treat serious diseases, products in short supply, early generics and drugs that have either been approved in the U.S. and EU or are undergoing review in those regions.
Under the policy proposal, companies submitting a drug can request priority review-status from the CFDA’s Center for Drug Evaluation if the application meets one of eight predefined categories. If approved, the application would receive set timelines for review, testing, inspection and final disposition.
Its connection to an existing priority review pathway — referred to as China’s “Green Channel” — is unclear. The Green Channel is available to domestic companies.
In the case of clinical trial applications for rare or life-threatening diseases, the agency may grant conditional approval based on just Phase 1 and Phase 2 data if reviewers can reasonably predict or determine the clinical benefit has a significant advantage versus existing treatments. Trial applicants with less convincing Phase 1 and 2 data still may request an abbreviated Phase 3 trial to speed the drug to market.
The CFDA’s document did not include a timeline for implementing these procedural changes.
According to law firm Sidley Austin, the priority pathway is open to:
End of cut and paste...
If my understanding is correct then HL is funding the trials in China and the territories...and if my understanding is correct I wonder whether Apabetalone would be considered a Chinese drug by their rules.
Points to ponder anyway.