Asia Regulatory Roundup: CFDA Revises Guidance on Device Trials (29 March 2016)

Regulatory NewsRegulatory News | 29 March 2016 |  By 

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

China Introduces Revised Guidance on Clinical Trials of Medical Devices

China Food and Drug Administration (CFDA) has introduced a good clinical practice (GCP) document covering medical devices. The text describes how CFDA expects sponsors and other organizations to handle aspects of medical device trials, from the initial preparations through to the maintenance of data once a study has been completed.

CFDA has released the text to clarify and strengthen aspects of the regulation overseeing companies that are running trials with a view to generating data to support regulatory submissions for devices, with the exception of in vitro diagnostic reagents which are excluded from the document. In the revised text, which is the first update to China’s medical device clinical trial guidance in 12 years, CFDA lays out a new definition of sponsor, strengthens the informed consent process and details the length of time sites should retain data after a study has finished.

Law firm Ropes & Gray outlined the most significant changes in a blog post. Under the new GCP text, the sponsor must be a device manufacturer. Previously, CFDA defined the sponsor as the applicant that filed the registration. The scope of responsibilities placed upon sponsors has shifted, too. CFDA has clarified that sponsors are responsible for revising investigator brochures in response to changes to the study, as well as seeking clearance from the ethics committee to make the alterations. The burden of appointing qualified monitors to oversee a study also falls on sponsors.

The requirements are part of a suite of stipulations designed to ensure trials are conducted ethically and in a way that generates legitimate, reliable data. Now, whenever a sponsor makes a change to an informed consent form that could affect the willingness of participants to stay in the trial, it must show the revised text to people who are already enrolled. As with revisions to investigator brochures, sponsors must gain approval from the ethics committee to make the changes. Other amendments to the guidance include the requirement that trial sites keep all data and materials for 10 years.

CFDA worked on the document with the National Health and Family Planning Commission of China (NHFPC), resulting in a lengthy text that covers 96 specific points across 11 chapters. While the text has been trimmed since CFDA first proposed the draft in 2012, at which time it featured 103 specific points, it still represents a significant expansion on the existing GCP document for medical devices. The current text, which was introduced in 2004, features just 29 specific points across 7 chapters. CFDA will replace that text with the 11-chapter revision on 1 June.

Collectively, the changes are intended to protect the rights of clinical trial participants and ensure medical devices are backed up by legitimate data demonstrating their safety and efficacy. CFDA has addressed related issues regarding medical devices in a series of regulatory updates in recent years, over which period it has published documents covering quality oversight, adverse event reporting and other topics. Earlier this month, CFDA indicated a willingness to back up its documents with actions when a sampling and testing initiative found fault with the quality of tens of medical devices.

CFDA Notice, GCP Document (Chinese), CFDA Explainer (Chinese), Ropes & Gray

CFDA Vows to Fix Regulatory Loopholes Following Vaccine Scandal

CFDA Deputy Director Wu Zhen has vowed to resolve the regulatory shortcomings that enabled an illegal vaccine ring to work undetected for years. Work to identify and fix the failings of the existing regulatory system is taking place in parallel to an investigation into the vaccine ring, which has now led to the detention of more than 130 people.

With some Chinese people and even parts of the state-backed media criticizing the government’s handling of the case, Wu Zhen and Premier of the State Council of China Li Keqiang have both spoken of the need to upgrade the regulatory system. Li Keqiang has called for the closing up of perceived loopholes in the regulations covering vaccine distribution, while Wu Zhen has committed to analyzing the vulnerabilities that allowed the ring to sell improperly-stored products. Once the weaknesses are known, Wu Zhen plans to take steps to ensure they cannot be exploited again.

The World Health Organization (WHO) has sought to reassure the Chinese population that vaccines kept outside the cold chain are unlikely to cause harm. Such reassurance is intended to counter the risk of a rise in anti-vaccine sentiment following the scandal, which could ultimately cause more harm than the incident itself. WHO is worried about supply chain regulation, though. “This incident has highlighted the need for much stricter enforcement of vaccine management regulations across the board,” WHO China representative Bernhard Schwartländer told Reuters.

WHO is content with the quality of vaccine producers in China, as evidenced by its prequalification of two local manufacturers in recent years, and the distribution of products through the government’s Expanded Program on Immunization. As WHO sees it, the remaining loopholes are a result of a disconnect between these practices and those followed in the private sector. “The problem that last week's events has brought to light is that distribution of vaccines for the private market does not follow the same high standards,” Schwartländer said.

Zhen Comments, CFDA Notice, Keqiang Statement, WHO Response (All Chinese), Reuters

CDSCO Shares Expert Committee Report that Triggered FDC Ban

The Central Drugs Standard Control Organization (CDSCO) has released the expert committee report that led to the controversial ban of 344 fixed-dose combination (FDC) drugs. In the 251-page report, the expert committee outlines its overall approach to the review and provides a brief overview of how it came to a decision about each particular FDC.

When reviewing the FDCs, the expert committee looked at a range of factors, including safety, abuse potential, dosage compatibilities and the international status of the products. This resulted in the creation of a list of FDCs that were considered to be irrational and others for which further data or deliberation were needed. Having completed the list in April 2015, the committee says it sent “show cause” notices to the manufacturers of the irrational FDCs. Replies were then considered before the committee made its final rulings, the details of which are contained in the report released this week. 

In the case of a syrup combining chlorpheniramine maleate and codeine phosphate, the dosage form and active ingredients of Pfizer’s Corex, the expert committee brought up three concerns. As with many of the FDCs, the committee ruled the dosage schedule is incompatible. In addition, the panel concluded that both ingredients would “aggravate the adverse effects of sedation and drowsiness,” while also interfering with reflexes. This mix of effects contributes to the syrup having “a high risk of abuse potential.”

Pfizer and its peers remain unconvinced and are continuing with their legal challenges to the ban. The High Court in Delhi is in the middle of hearing the cases. As well as hearing from those arguing against the ban, the court has given the government an opportunity to put its case across, legal news publication Bar & Bench reports. “The Government has made elaborate attempts to ensure that all facets of the matter get duly examined and no injustice is done to anyone. In the process sufficient notice and opportunity had been given to all concerned to present their case,” the government said as the case continues.

CDSCO Release, Bar & Bench



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