China Creates Priority Review Path to Speed Approval of Some Drug Types
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:
In related news, the CFDA issued a draft guidance detailing new requirements for onsite verification of clinical trial data for drugs.
The guidance notes that inspections will be conducted by the CFDA’s Center for Food and Drug Verification, according to Sidley Austin.
The CFDA will notify companies and regional authorities 10 days in advance of any inspection. Companies may withdraw their drug registration application during that timeframe, with failure to do so being construed as consent to the verification check.
Pre-approved verification of clinical data “may become a routine CDFA requirement,” Sidley says, and the findings from such checks will inform CFDA’s technical review of drugs in the future.
Read Sidley Austin’s summary of the document here: www.sidley.com/~/media/update-pdfs/2016/03/20160302_china-food-and-drug-administration-creates-a-prioritized-drug-review-and-approval-pathway.pdf.
Read Sidley Austin’s summary of the clinical trial proposal: www.sidley.com/en/news/03-01-2016-global-life-sciences-china-update. — Cameron Ayers
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