Posted 05 December 2017
By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
Australia Bans Transvaginal Mesh Products Following Risk-Benefit Review
Australia has banned transvaginal mesh products used in the treatment of pelvic organ prolapse. The Therapeutic Goods Administration (TGA) took the action after concluding the risks of the controversial treatment outweigh the benefits.
Patients and healthcare experts around the world have questioned the use of the medical implants for years, leading to a legal initiatives including a 700-person federal court class action case against Johnson & Johnson and reviews of the device’s risk-benefit profile in the United States and Europe. The United Kingdom’s regulatory agency is reportedly preparing to ban the use of vaginal mesh to treat pelvic organ prolapse, but its peer in Australia has moved first.
On 4 January, TGA will issue notices to remove devices from the Australian Register of Therapeutic Goods (ARTG) or otherwise impose constraints on their use. The notices target transvaginal mesh products used to treat pelvic organ prolapse and single incision mini-slings used to treat stress urinary incontinence. In both cases, TGA thinks the risks outweigh the benefits.
Sponsors affected by the notices have 90 days to ask TGA to review its decision.
The planned ARTG cancellations mark the culmination of a four-year period in which TGA has paid particular attention to the safety of devices designed for urogynecological use. Over that time, the agency has banned 43 devices and prohibited the use of another two products in urogynecological procedures. Many of the actions followed TGA’s 2013-14 review of the safety of the devices.
That review found “little evidence” to support the overall effectiveness of urogynecological mesh implants. However, as TGA saw the data as suggesting certain patients may benefit, it shied away from an outright ban on the use of the devices in the urogynecological context.
TGA’s decision to take a harder line against the implants follows a review of recent international studies and up-to-date clinical evidence. A meta-analysis published in Obstetrics & Gynecology last year found mesh erosion rates, a widely reported complication, ranged from 1.4% to 19%. Those numbers shot up to 3% to 36% when the mesh was implanted in multiple compartments.
The authors behind the meta-analysis, like TGA during its 2013-14 review, noted shortcomings in the quality of the literature. However, with the quality improving over time, TGA now thinks there is sufficient evidence to remove devices from the ARTG.
China Proposes Draft Rules on Regulatory Handling of Confidential Information
The China Food and Drug Administration (CFDA) has outlined how it will maintain the secrecy of confidential information submitted by developers of drugs and medical devices. CFDA set out its approach to confidentiality in draft guidance designed to prevent unauthorized disclosures.
In the draft, CFDA details how it plans to safeguard the interests of applicants while standardizing and strengthening its information security management processes. The centerpieces of the draft are two sections that define the information CFDA sees as confidential and the situations it thinks amount to disclosure.
CFDA’s definition of confidential information covers both the commercially sensitive materials filed by applicants, such as test data and technical parameters, and the unpublished discussions and analyses related to submissions.
The agency sees a range of ways in which its staff could unlawfully disclose such information. These range from the blatant release of confidential information to third parties to less obvious breaches, such as the sharing of passwords and unauthorized moving of materials away from the workplace. CFDA covers multiple other scenarios in the draft, including the unauthorized copying of materials and the use of equipment and facilities that fall short of confidentiality requirements.
Other sections of the guidance delve into confidentiality considerations for regulatory processes and technologies. CFDA is instructing its staff to talk to applicants on dedicated telephone lines. The use of personal email addresses is banned. CFDA is prohibiting staff involved in the review and approval of products from investing in pharmaceutical companies.
CFDA staff found to have breached the guidance could face anything from an internal warning to criminal prosecution, depending on the seriousness of the violation.
The agency is accepting comments on the draft until the end of the year.
CFDA Notice (Chinese)
TGA Posts Guidance on Variation Process for Approved Biologicals
TGA has released guidance on when and how companies with approved biologicals should make changes to the ARTG entry. The guidance walks companies through the process of determining if a variation is required before detailing the steps they need to take before implementing the change.
The final text applies to products regulated as biologicals, not the broader category of prescription biologic medicines. This makes it relevant to companies that make medical products using human cells or tissues or live animal cells, tissues or organs. If the manufacturer of such a product wants to make a change that would have been relevant to the original approval, it must contact TGA.
A manufacturer’s first step, therefore, is to determine if the change would have been relevant to the initial inclusion decision. TGA’s guidance poses a series of questions to help companies make this determination. The questions probe whether the change will alter critical in-process controls, nullify previous validation studies or affect the risk-benefit profile.
If the revision results in these changes or other major events, a variation application is needed. The company cannot implement the revision until TGA signs off on its variation application. Changes classed as notifications can proceed without TGA approval, but this category is limited to very low risk amendments. For bigger changes, the applicant must file supporting documents and wait for TGA’s decision.
TGA aims to screen most applications in 15 working days, although the legislated timeframe for telling a company whether it will evaluate an application is 30 days. The length of the evaluation is dictated by significance of the change. TGA gives itself 45 days to handle minor variations and 255 days to process major variations.
No timeframe applies to corrections of entries in the ARTG.
CFDA Establishes Transition Period for Chinese Medicine Naming Rules
CFDA has set up a process for transitioning to its new system for the naming of Chinese medicines. The agency is creating a two-year transition period from the approval of the new name onward to give doctors and patients a chance to adapt to the change.
Manufacturers have less time to adapt. CFDA expects companies to submit a new label and leaflet within 30 days of the approval of the new name.
The changes to the naming process are designed to standardize Chinese medicines and prohibit the use of certain types of words. Companies cannot use names that exaggerate the effect of their product or those that mimic prescription drug brands.
Working from these guidelines, the Chinese Pharmacopoeia is creating a list of names that need changing. Once this list is published, manufacturers of products on the list will have two months to submit a proposed common name. The Pharmacopoeia will review the applications.
CFDA Guidance (Chinese)
Other News:TGA has released an online tool for searching recently published or amended product information documents. The tool is intended to help generic sponsors comply with their legal obligation to respond to safety updates made by the manufacturers of their reference products. TGA said this was “a tedious and time-consuming” task before it created the tool. TGA Notice