Asia Regulatory Roundup: China Posts Guiding Principles on Device Trials (9 January 2018)

Regulatory NewsRegulatory News | 09 January 2018 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

China Seeks Feedback on Drug Data Management Practices

China is seeking feedback on its draft drug data management practices. The China Food and Drug Administration (CFDA) text details how individuals and organizations involved in the development, production, distribution and monitoring of drugs should ensure the accuracy and traceability of the data they generate.

CFDA has used the draft to plot out the process of assigning creators to data, tracing it through the system and archiving or destroying records. The process is intended to stop companies from taking the deliberate and inadvertent actions that have made the unreliability of data a recurring theme in regulatory warning letters in recent years.

The agency mostly takes a descriptive, not prescriptive, approach to the systems it wants companies to put in place to avoid these problems. CFDA specifies only authorized personnel should be able to process and store data or access archives. The agency also expects accounts to be protected by strong passwords that are changed regularly.

In keeping with many of its guidelines, CFDA is placing ultimate responsibility for the implementation of the data management practices on senior management. CFDA expects people in senior positions to create a culture of quality and make resources available to enable their employees to comply with the practices. This entails stopping business pressures from affecting work related to data reliability and providing relevant training to staff involved in good practices.

The guidance places responsibilities on all other members of organizations. CFDA expects everyone to report any data reliability issues they discover.

CFDA is accepting feedback on the draft until 5 February.

Draft Guidance (Chinese)

Philippines Creates Task Force to Review Sanofi Dengue Vaccine Approval Process

The Philippines FDA has created a task force to review records related to the approval of Sanofi’s dengue vaccine. Officials followed up the action by suspending sales of the vaccine and fining Sanofi $2,000.

Sanofi’s pioneering dengue vaccine is in the regulator’s crosshairs on the back of data suggesting it may make the disease worse in some cases. That has led to the Philippines mounting an investigation into how the vaccine came to be given to 730,000 children in the country. The task force will conduct “a comprehensive review of all the records relating to the approval” of Sanofi’s Dengvaxia.

To facilitate the investigation, the task force has been empowered to access and retain all files related to the vaccine. The group will review these documents and other resources before recommending actions for the Philippines to take in response to its findings. 

The regulator alerted the public to the creation of the task force, which was set up at the start of last month, to ensure all submissions and requests related to Dengvaxia are directed to the right person. Any submissions sent to places other than FDA’s action center will not be considered as official.

Work by the task force is taking place in parallel to other reviews and actions relating to the vaccine. This week, FDA found Sanofi had violated post-marketing surveillance requirements, Reuters reports. The Philippines has fined Sanofi $2,000 and suspended its certificate of product registration in response.

FDA Notice, Reuters

CFDA Posts Guiding Principles for Medical Device Clinical Trials

CFDA has released guiding principles for the design of medical device clinical trials. The document covers the basics of all clinical trials, such as blinding and randomization, before delving into some of the specific factors developers of medical devices must consider.

Much of the ground covered in the document will be familiar to people well versed in designing clinical trials of medical devices and other interventions. A sizable portion of the text is given over to explanations of the various types of study design, the selection of primary and secondary endpoints and statistical aspects of creating rigorous trials.

CFDA also goes into considerations of particular importance to medical device companies, such as the need to take human factors into account when designing and developing products.

The document is notable as much for its existence as its content. In recent years, CFDA has revised the regulations covering the full lifecycle of medical devices, in part to raise the standard of products developed and sold in China. The medical device clinical trial 101 released this week provides companies with a basis for how to design studies.

This could be particularly valuable to companies unused to running studies with the rigor CFDA now expects to see and, by extension, to China’s attempts to encourage medical device innovation while raising standards.

CFDA Guidance (Chinese)

TGA Clarifies Special Access Scheme Adverse Event Reporting Requirements

The Therapeutic Goods Administration (TGA) of Australia has updated its guidance on the use of unapproved therapeutic goods. TGA’s changes clarify the adverse event reporting requirements for drugs made available to patients under its special access scheme.

Australia created the scheme to provide treatments for patients for whom all approved products are clinically unsuitable. Several pathways exist to enable doctors to access such drugs for their patients. All the pathways are covered by adverse event reporting requirements, but these were inadequately elucidated in the original guidance. TGA has now addressed this shortcoming.

The revised guidance is more strongly worded. The original text “encouraged” sponsors to report “all serious unexpected adverse events.” In the latest text, TGA has replaced “encouraged” with “expect” and dropped “serious” from the description of the adverse events it wants sponsors to report.

TGA has made similar changes to its description of the timelines for reporting these events. The older text said sponsors should “ideally” file reports about fatal or life-threatening outcomes within seven calendar days. In the revised guidance, TGA states sponsors “should” meet this deadline and others described in the text.

TGA Guidance

CFDA Creates Regulatory Strategy for Inspection of Medical Devices

CFDA has detailed how it will deploy its resources to ensure medical device companies adhere to its standards. The strategy tasks central and regional units of the regulatory agency with cooperating on the inspection and oversight of companies in the medical sector.

Officials at CFDA are expected to supervise the work of medical device inspectors. This will entail making sure inspections are completed within a reasonable amount of time and reports based on the visits are issued. If problems arise, CFDA expects its staff to address them promptly by improving their coordination with and supervision of the inspection teams.

The document also includes a section aimed at inspectors themselves.

CFDA’s publication of the inspection strategy follows a period in which it has made multiple changes to the regulation of medical devices to raise standards and encourage innovation.

CFDA Notice (Chinese)

Other News:

The Central Drugs Standard Control Organization (CDSCO) has delegated the issuing of certain drug import licenses to its zonal, sub-zonal and port offices. CDSCO is devolving import license powers in cases in which the applicant is a government hospital or autonomous medical institute using Form 11a. CDSCO Notice

CFDA has hired and trained 148 good supply practice inspectors. The hiring drive follows work since 2015 to improve supply practices in China. CFDA described the 148 inspectors as the first batch of people it is taking on to ensure good supply practices are followed in the country. CFDA Notice (Chinese)



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