In 2015, China’s State Council outlined a major regulatory reform plan in a document published on the CFDA.
The plan detailed five main goals, including improving regulatory review and approval quality, addressing the drug application backlog, upgrading generic drug quality, promoting drug research and development, and enhancing regulatory transparency.
At the DIA Annual Meeting this year, members from various organizations in the CFDA discussed these initiatives, progress being made, and plans for future reform.
“We’re not going to stop … reform will continue,” said Ling Su, PhD, Venture Partner, Lilly Asia Ventures, China, during the CFDA update at the meeting in Chicago, IL.
CFDA program on GCP revision
The CFDA is revising GCP to specify responsibilities of the sponsor, ethics committee, and investigator. As part of the revision, the program aims to optimize serious adverse event (SAE) and suspected unexpected serious adverse reaction (SUSAR) reporting and is adding a requirement for sample retention of IMP in bioequivalence.
The GCP revision also addresses data integrity, including validation and data requirements such as ALCOA+ (Attributable, Legible, Contemporaneous, Original, and Accurate) and SOP (Standard Operating Procedures).
According to Su, these reforms will help meet the needs of the public, accelerate new drug evaluation, and protect the integrity and reliability of research data.
“I believe that reform has attracted the attention of all related professionals,” he said, welcoming suggestions to help improve the benefits to patients, and expressing the desire to work with international stakeholders.
Su said international cooperation has become increasingly important as the industry looks to establish a “harmonized quality and safety standard.”
On this same note, the CFDA announced that the International Council for Harmonization (ICH) Assembly has approved administration as a new regulatory member. As a member of ICH, the CFDA gains access to an international forum and will have the ability to vote on items including draft ICH guideline endorsement and final ICH guideline adoption.
“In 2017, CFDA will continue with reform in different areas,” Su added, specifically addressing the application backlog and the quality and efficiency of drug evaluation. “We will push forward for further developments, guidances, and reference materials,” he said, and data forging will be “severely punished.”
Clinical trial data integrity
On July 22, 2015, the CFDA announced a program for self-audit and verification of clinical trial data.
The goal of the announcement was to ensure the authenticity and reliability of clinical trial data submitted to the CFDA, in addition to ensuring subject protection.
The program allowed applicants of drug registration to complete self-audits according to GCP to ensure the clinical trial data submitted to CFDA was “authentic and reliable” with “relevant records and documents complete,” according to the administration.
1,622 applications were involved, of which 81% were eventually found to contain fraudulent data, as per the report.
Moving forward, Zhimin Yang, MD, division director, Center for Drug Evaluation, CFDA, said strengthening site inspection will help ensure the reliability of clinical trial data.
“Over the past decade the clinical trial has changed rapidly in China,” added Rong Zhang, MS, deputy chief technician, CFDA. “CFDA is trying its best to strengthen clinical trial operations by stressing site inspection to ensure reliability of clinical trial data,” he added.
The administration is also working to improve legislation that will “encourage the stakeholders in clinical trials to work together to improve data quality and the reliability of the clinical trial,” he said.