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:

  • Drug applications for products with “significant clinical value,” such as innovative drugs and those with advanced formulations;
  • Clinical trial applications for generic drugs submitted three years before the patent expires on the reference product;
  • Clinical trial applications for new drugs undergoing parallel review in the U.S. and EU;
  • Registration applications for drugs undergoing parallel review in the U.S. and EU using the same production line;
  • Registration applications for new drugs developed under Chinese national research programs;
  • Registration applications for drugs to treat AIDS, tuberculosis, viral hepatitis, rare diseases and cancer, as well as pediatric and geriatric drugs;
  • Registration applications for drugs in short supply approved by China’s National Health and Family Planning Commission and the Ministry of Industry and Information Technology; and
  • Registration applications for pediatric drugs that have been approved in the U.S., EU and “surrounding areas” of China, backed by compelling clinical data.

Onsite Inspections

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

$895 $695

Bonus

Subscribe to International Pharmaceutical Regulatory Monitor and save $200 off the regular one-year price of $895 — plus receive a FREE CD copy of our webinar The 24 Elements You Need for a World-Class Quality Agreement — a $287 Value!

Key Benefits

LINKS TO KEY DOCUMENTS — Each issue provides English-language texts of important, hard to obtain proposals, regulations, guidelines and other documents.

FDANEWS DRUG DAILY BULLETIN — This daily email brings you important FDA and international regulatory, legislative and business news in the pharmaceutical industry.

ONLINE ACCESS — Consider our newsletter archive your personal library! Search your current issue — and hundreds of past issues — by keyword and relevancy.