Asia Regulatory Roundup: China’s NMPA Finds Fault With Quality Management Systems at Vaccine Facilities

RoundupsRoundups | 03 December 2019 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
TGA Blames Misunderstanding for Pushback Against 3D-Printed Device Proposals
Australia’s Therapeutic Goods Administration (TGA) has blamed some of the criticism of its ideas for regulating 3D-printed medical devices on a misunderstanding. TGA thinks respondents misconstrued the details of proposals including its plans to create a new product category called medical device production systems (MDPS).
The consultation, which closed at the end of March, sought feedback on TGA’s plans for regulating personalized medical devices. In light of the potential for healthcare providers to use 3D printers to make personalized, low-risk devices at the point of care, TGA proposed creating a new framework.
That proposal received a mixed response from respondents, leading TGA to conclude “there was less obvious support” for the idea. TGA thinks the negative feedback stems from a misunderstanding, not a rejection of the thinking behind the creation of the MDPS category.
“It was clear that much of the feedback stemmed from a misunderstanding of how the regulations would apply both to these devices and to other types of manufacturing systems, for instance, that Medical Device Production Systems are intended to be turnkey solutions for producing particular medical devices—not open manufacturing systems for hospital use, that their use would not be compulsory and that their respective manufacturers would be responsible for validating their use by end users; the consultation paper was, perhaps, not sufficiently clear on these points,” TGA wrote.
The plan to create the MDPS category received broad support from organizations including Johnson & Johnson and the Medical Technology Association of Australia. However, even some of the groups that support the concept had concerns with the specifics of its implementation.
J&J, for example, articulated concerns about how the conformity assessment, review and control process will work in practice, in part because of questions about the split of responsibilities between the device company and the facilities that use the MDPS. Specific questions raised by J&J include a query about how conformity assessment procedures would handle ongoing environmental controls.
After receiving the feedback, TGA held further discussions at events. The process has convinced TGA that “significant education and information materials and workshops will be required” to make its plans for 3D-printed devices work. TGA plans to create detailed guidance to support this effort.
Consultation Submissions
TGA Details Problems Breast Implant Makers Need to fix to Regain Market Access
TGA has shared details of the quality problems certain manufacturers of breast implants need to fix if their products are to be let back onto the market. All the manufacturers have failed to provide the carcinogenicity information required by the ISO standard on biological evaluation of medical devices.
In September, TGA decided to suspend eight products sold by four companies from the Australian Register of Therapeutic Goods (ARTG) to protect patients while the affected businesses fix safety and performance concerns. Now, TGA has shared more details of the issues it wants Eurosilicone, Groupe Sebbin, Nagor and Polytech Health & Aesthetics to address.
Many of the same problems affect all the devices. Notably, TGA cites either shortcomings in evidence related to carcinogenicity or the total absence of carcinogenicity testing in its assessment of each of the devices. The suspensions stemmed from reports of cancers in women with breast implants.
TGA also found fault with the work done on reproductive toxicology and immunotoxicology by all the companies. Other safety and performance problems affecting one or more of the companies relate to biodegradation, cytotoxicity and implantation. TGA spotted the problems by checking compliance with the Essential Principles and international standards.
The eight products are due to be off the market until late April. If the affected companies remedy the deficiencies by then, TGA may reinstate the products to the ARTG. Failure to fix the problems could result in the cancellation of the devices from the ARTG. 
TGA Statement
China’s NMPA Finds Fault With Quality Management Systems at Vaccine Facilities
China’s National Medical Products Administration (NMPA) has identified a need for manufacturers of vaccines to improve their quality management systems. NMPA spotted the shortcoming during an industry-wide inspection program that generated a broadly positive picture of vaccine producers.
Quality practices at Chinese vaccine manufacturers remain in the spotlight in the wake of a series of scandals. In recent years, there have been multiple reports of substandard, expired and improperly stored vaccines being administered to children. Investigations into the scandals have found evidence of data fabrication and raised concerns about the relationship between industry and regulators.
Chinese authorities responded by inspecting all 36 vaccine manufacturers in China between May and October of this year. NMPA reported the findings of the inspection program last week.
The 197 inspectors found the companies complied with good manufacturing practices and were not engaging in illegal activity. That said, NMPA also identified scope to improve quality management systems and strengthen quality control and document management. NMPA communicated its findings at a meeting with vaccine producers that called for the industry to continuously improve.
NMPA Statement (Chinese)
India Takes Action to Strengthen Reporting of Adverse Events Linked to Medical Devices
The Central Drugs Standard Control Organization (CDSCO) has asked its staff to encourage healthcare professionals to report adverse events linked to medical devices. CDSCO’s request is part of an effort to strengthen the materiovigilance program in India.
India formally introduced a materiovigilance program and put the Indian Pharmacopoeia Commission in charge of coordinating it in 2015. To encourage reporting, IPC created a form, which can be sent by post or email, and opened a phone line, giving people multiple ways to share details of adverse events. However, local media reports suggest the rate of reporting is low.
Against that backdrop, the Drug Controller General of India VG Somani has written to his colleagues and manufacturers and importers of medical devices. Somani asked the recipients to advise “all clinicians and other healthcare professionals under your jurisdiction to mandatorily adopt reporting of medical devices adverse event.” The word “mandatorily” is crossed out in Somani’s letter.
One criticism of the materiovigilance program is that it lacks mandatory reporting. Draft guidance released by IPC last year said it is the “responsibility” of stakeholders to report adverse events linked to medical devices.
CDSCO Notice, Pharmabiz
New Zealand Creates Guidance on Marketing Unapproved Medicines
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has published a guide to marketing unapproved medicines. Medsafe’s guide is aimed at companies that supply products under exemption provisions in the Medicines Act of 1981.
In New Zealand, some healthcare professionals are exempt from restrictions on the sale of unapproved medicines. Complementary medicines can also be sold without first getting Medsafe approval.
The guide released by Medsafe states products provided under the exemption available to some healthcare professionals cannot be advertised. Medsafe uses the guide to explain the implications of that position, noting that the Medicines Act features a broad definition of advertising that prohibits many actions.
Medsafe takes a different approach to complementary medicines, which can be advertised if they do not contain a scheduled substance and are not for therapeutic use. The marketing materials must not infer a therapeutic purpose for the products.
To help companies comply with the restrictions, Medsafe included its advertising guidance in the text and shared details of the pre-vetting service offered by the Association of New Zealand Advertisers. 
Medsafe Guide


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