Asia Regulatory Roundup: CFDA Releases New Guidance on Device Trial Inspections (24 May 2016)

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

CFDA Releases Clutch of Draft Medical Device Clinical Trial Texts

China Food and Drug Administration (CFDA) has released a handful of draft documents about clinical trials of medical devices. The documents, which detail the process for on-site inspections and the products that are exempt from studies, continue the ongoing overhaul of the regulation of medical devices in China.

CFDA released the documents in separate posts that went out within days of each other. The first post covered three draft documents about inspections of medical device clinical trials. In one of the documents, CFDA provides a long list of points regulatory officials should check when inspecting the conduct of medical device clinical trials. Most of the points, such as whether the informed consent process meets the relevant requirements, are applicable to all clinical research programs. Others are more specific to the conduct of clinical trials of medical devices.

The regulator released the checklist alongside two other draft documents. One of the texts, referred to as annex 3, details the process CFDA inspection teams should follow from the preparatory meeting through to the filing of final reports. By setting out the seven-step process, CFDA has created a guide that, if followed, should increase the chances of regulatory teams arriving for site visits knowing the tasks they will be carrying out and what sort of evidence they intend to gather. In a large country, which is looking to local teams to oversee trial sites, such consistency could prove valuable.

Two days after releasing the on-site inspection documents, CFDA shared draft texts listing the Class II and III medical devices it is proposing to exempt from clinical trials. The Class III document starts with needles, a well-established class of products that typically follow the same basic principles. CFDA is only offering the exemption to products that follow the principles set out by earlier products. If, for example, a needle uses a new material, features a novel coating or has a design that diverges from established products, CFDA will request a clinical trial.

This model, in which the defining characteristics of exempt products are listed alongside examples of modifications that would necessitate a clinical trial, is applied throughout the Class III document. The text covers 93 types of Class III medical devices that will, under certain circumstances, be exempt from clinical trials. CFDA has taken a slightly different approach to the more than 250 types of device covered by the Class II document. For these lower-risk devices, such as bone cement filling kits, CFDA has typically not listed conditions under which trials are needed, although it has for some products.

CFDA is accepting feedback on the three on-site inspection documents until 27 May. The comment period on the lists of devices that are exempt from clinical trials is open until 20 June.

On-Site Inspections, Trial Exemptions (both Chinese)

TGA Posts Guide to Harmonization of Medicine Ingredient Names

The Australian Therapeutic Goods Administration (TGA) has posted a guide to help companies with the ongoing harmonization of medicine ingredient names. TGA initiated the transition period on 6 April and, in doing so, began a countdown to the date by which companies must have adopted the new naming practice.

Companies with products on the market that contain active ingredients or excipients affected by the revised naming policy have four years to bring their labels and product information in line with the new terminology. Sponsors are under no obligation to make the changes at the next variation to their products. In some cases, TGA is requesting that sponsors use both the old and the new names on the label and product information until 2023. The old names are to be included in parentheses, so, for example, the drug formerly known as “lignocaine” will be called “lidocaine (lignocaine).”

If a sponsor makes a major variation to an existing medicine and, in doing so, creates a new product in the eyes of TGA, it must use new ingredient names on the label and product information from day one. The same policy applies to completely new products. TGA is asking that all newly listed products on the Australian Register of Therapeutic Goods (ARTG) use the latest active ingredient and excipient names, regardless of whether they are wholly original or were created through a major variation of an existing medicine.    

TGA is adapting the process depending on whether the product is a registered or listed medicine, though. Manufacturers of listed medicines, products TGA considers “relatively benign,” can update their labels and product information without first providing the revised materials to TGA. In contrast, manufacturers of registered medicines must file a copy of the updated label and product information with TGA for approval before making a change. The paperwork process is slightly different depending on whether the product is sold on a prescription or over-the-counter basis.

The release of the guide is the latest step in the long-running harmonization agenda. TGA signaled its intent to change some ingredient names when it began a consultation on the plan in 2013. TGA initiated the process to harmonize the names of ingredients that were added to ARTG before 2002 with the World Health Organization’s (WHO) International Non-proprietary Name (INN) terminology. Australia has used the terminology since 2002, but several hundred older ingredients have names that are inconsistent with WHO’s INN.

In some cases, manufacturers of generic medicines have adopted these old active ingredient names as their trade brand. These sponsors are under no obligation to bring their trade names in line with the new naming convention but, if they choose to do so during the transition period, TGA will waive the fee that it typically demands for such amendments.  

TGA Guide

Inner Mongolia Sets Proposal to Create Independent FDA

Inner Mongolia has outlined a plan to establish an independent Food and Drug Administration (FDA). The region, a sparsely populated autonomous area of northern China, put forward the proposal as part of a clutch of measures designed to ensure that it is equipped to monitor the safety and efficacy of products sold in the territory.

Officials in the government of Inner Mongolia think the actions are needed to ensure the region can meet regulatory responsibilities it is entrusted with under the devolved oversight model practiced in China. The centerpiece of the proposal is the creation of an independent FDA, an organization that will work with other departments in the region to ensure inspections, testing and other regulatory activities are carried out effectively.

As part of this process, the government is proposing to establish a regulatory team commensurate with the size of the population in the region. This agenda will be supported by the establishment of a system for qualifying professional inspectors and training up new recruits.  

CFDA Notice (Chinese)

Other News:

Reuters has reported on the staffing difficulties faced by CFDA. The regulator is reportedly struggling to retain staff because the companies it oversees can offer higher salaries and more freedom. One source said people can earn five times more by moving from the regulator to the industry. “The brain drain of skillful people definitely impacts the CFDA's ability to operate, especially for example its ability to evaluate new drugs,” Cheng Gang said. Cheng left CFDA in 2014 to set up his own company. Reuters