Asia Regulatory Roundup: TGA Adopts Risk-Based Model for Fecal Microbiota Transplants

RoundupsRoundups | 24 September 2019 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
TGA Adopts Risk-Based Model for Fecal Microbiota Transplants
Australia’s Therapeutic Goods Administration (TGA) has adopted a risk-based approach to the regulation of fecal microbiota transplants (FMT). TGA decided to treat FMT products as anything from Class 1 biologicals to Class 4 medicines after running a public consultation earlier in the year.
The model TGA settled on will result in most FMT products being categorized as Class 1 biologicals, the term the agency uses to describe tissue and cell-based products. TGA will treat FMT products as Class 1 biologicals if they are minimally manipulated, use feces from “appropriately screened donors” as the starting point and are manufactured and used in the same hospital under the supervision of the registered medical practitioner who is caring for the patient who will receive the transplant.
TGA will place some regulatory responsibilities on sites that handle Class 1 biologicals. The agency expects the sites to comply with certain standards and have “an appropriate” quality management system. The site will need to file for the FMT product to be added to the Australian Register of Therapeutic Goods (ARTG) but will be spared the need to hold a good manufacturing practice (GMP) license or undergo premarket assessment by TGA.
Sites that handle products that fall into higher risk categories will face tougher requirements. TGA will treat a FMT product as a Class 2 biological if it is made outside the hospital where it is used. In that scenario, the sites that manufacture and test the FMT product will need a GMP license.
TGA will treat products that undergo more than minimal manipulation as Class 3 or 4 biologicals or medicines. That position reflects a belief that FMT products “processed using methods that may have altered any of the biological characteristics or physiological functions of the stool” may pose greater risks.
The risk-based model is intended to ensure safety while maintaining patient access, and reflect “the current high level of clinical oversight and hospital governance for some FMT products.” However, the consultation revealed concerns about different aspects of the model. BiomeBank, a public stool bank, challenged the idea that hospitals are equipped to manufacture FMT products.
“We believe hospitals are not the ideal sites to prepare biological materials because the risk of contamination would be higher than in dedicated laboratory facilities. Hospital environments also have high levels of multi-resistant organisms, and this in combination with the lesser degree of manufacturing standard required within this environment, is not ideal,” the stool bank wrote.
Hospitals attacked the proposal from other angles. Gastroenterologists at St Vincent’s Hospital in Melbourne, for example, said the need to include FMT products in the ARTG “raises a number of issues” related to a perceived disconnect between the nature of the treatments and the regulatory requirements.
TGA acknowledges its approach will force the sector to adapt and wants to support this process. The next step is to develop detailed guidance on the topic and set minimum standards for the screening or donors and FMT products. TGA intends to make the documents available in time for sites to adapt to the rules, which will be implemented on 1 January with a 12-month transition period that pushes the effective go-live date back to the start of 2021.
TGA Statement, Consultation Feedback
China Joins IMDRF’s Post-Market Device Safety Data Exchange Scheme
China has joined the International Medical Device Regulators Forum’s (IMDRF) national competent authority report (NCAR) exchange program. NCAR supports the global distribution of post-market safety information in an attempt to stop medical devices from causing serious harm to patients.
Regulators in Australia, Brazil, Canada, the European Union, Japan and the United States use NCAR to exchange information about medical devices. When IMDRF last updated NCAR in 2012, the program supported the exchange of around 250 reports a year. However, the absence of large countries from the program has left it unable to fully capture global device safety data.
The involvement of China’s National Medical Products Administration (NMPA) goes some way to address that shortcoming. NMPA joined the program to obtain access to timely information about medical device safety and to contribute to the global supervision network.
NMPA shared details of its involvement with NCAR on the same day as it provided an update on its other work with IMDRF. At an IMDRF meeting last week, attendees approved guidance prepared by NMPA. The approval marked the first time IMDRF had approved guidance prepared by the Chinese regulatory agency.
NMPA Notice, More (both Chinese)
TGA Warns Carcinogen Contamination May Lead to Drug Shortages
Australia’s Therapeutic Goods Administration (TGA) has warned that investigations into the potential contamination of ranitidine medicines could lead to shortages. TGA is testing ranitidine medicines for contamination with N‑nitrosodimethylamine (NDMA).
The discovery of NDMA, the contaminant that sparked the sartan recalls, in heartburn medicines that contain ranitidine has led to regulatory actions around the world. Last week, Singapore’s Health Sciences Authority stopped the sale of eight ranitidine medicines, including Zantac, and other regulators began investigations.
TGA expects products to be recalled from the Australian market but is yet to report such an action. For now, the Australian response is limited to TGA’s commitment to test ranitidine medicines sold in the country to assess if those batches are contaminated.
While TGA is working to gather more information, it is advising healthcare professionals to consider whether the benefits of treating a patient with a ranitidine medicine outweigh the risks. TGA, like other regulators, thinks the risks posed by NDMA in ranitidine medicines are very low. Even so, for some patients those risks may outweigh the benefits. TGA wants physicians to consider alternatives.   
TGA Notice
China Shares Details of Timelines, Process for Unique Device Identifier Plan
NMPA has shared more details of the planned adoption of a unique device identification (UDI) system. NMPA plans to start the staggered rollout of the UDI requirements in August.
The first batch of medical devices expected to carry UDIs in China include active and passive medical implants, as well as some other higher-risk products. Devices included in the first batch released by NMPA this week will start shipping with UDIs on 1 August, 2020.
NMPA has set the same start date for activities related to the UDI registration system and database that will support the initiative. The Chinese agency is accepting feedback on the draft plan until 25 September.
NMPA Notice (Chinese)
Other News:
China’s Center for Drug Evaluation (CDE) is seeking feedback on its approach to the electronic common technical document (eCTD). The draft text provides advice on how to produce and submit eCTD applications that meet Chinese requirements. Authorities will reject noncompliant filings. CDE is accepting feedback until 17 October. CDE Notice (Chinese)
India’s Central Drugs Standard Control Organization (CDSCO) has asked manufacturers of a fixed-dose combination (FDC) featuring the nonsteroidal anti-inflammatory aceclofenac to perform active post-market safety monitoring on at least 200 patients with colicky pain due to smooth muscle spasm. CDSCO wants manufacturers to file the resulting report within one year. CDSCO Notice
China’s NMPA has released technical guidelines on the selection of endpoints in advanced non-small cell lung cancer clinical trials. The publication comes three months after CDE sought feedback on a draft NSCLC endpoint document. NMPA Notice (Chinese)


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