Asia Regulatory Roundup: TGA Seeks Feedback on Requirements for Fecal Transplant Manufacturing Sites

RoundupsRoundups | 19 November 2019 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
TGA Seeks Feedback on Requirements for Fecal Transplant Manufacturing Sites
Australia’s Therapeutic Goods Administration (TGA) is seeking feedback on the quality standards it plans to impose on manufacturers of fecal microbiota transplant (FMT) products. TGA wants to know how the changes will affect the sector and whether the proposed 12-month transition period is long enough.
TGA has spent more than a year gathering feedback on how to regulate FMT. After reviewing the 22 responses to its original consultation, TGA created a risk-based model that will categorize minimally manipulated FMT products as Class 1 or 2 biologicals. FMT products made at the hospital in which they are used will be Class 1, while those manufactured at one site for use elsewhere will be Class 2.
Australian officials sketched out the risk-based approach in September. Now, TGA has shared more details of what it will mean in practice for organizations that manufacture FMT products.
TGA plans to apply its general requirements on the labeling of biologicals to FMT products but thinks its existing standards on safe use of donated blood cells and tissues fail to cover all the controls it wants to apply to stool donors. As such, TGA has copied aspects of the existing screening standards but also introduced new requirements specific to FMT products.
The broad requirements on the collection and manufacture of FMT products and the facilities that perform these processes are largely lifted from the existing text. Through the requirements, TGA aims to ensure hospitals meet basic standards without subjecting them to good manufacturing practices.
Specific requirements proposed by TGA include the need for manufacturers of FMT products to hold face-to-face interviews with potential stool donors to learn their medical and social history. TGA wants the interviews to take place no more than one month before the stool donation and be held every three months for repeat donors.
The consultation also sets out criteria for judging whether someone is permanently or temporarily ineligible to provide a stool sample, for example because they are infected with the hepatitis C virus. TGA’s ineligibility criteria are in line with the consensus statements of regulators in other parts of the world, although there is necessarily some divergence given the lack of international harmonization in some areas.
Through the consultation, TGA wants to learn whether groups involved with FMT products agree with its proposed exclusion criteria. Other specific questions cover whether the proposed standards will create problems for manufacturers. 
TGA expects to finalize the FMT product standards in January and begin enforcing the requirements at the start of 2021. However, feedback on the draft released this week could change that plan. in the consultation document, TGA repeatedly asks whether the proposed 12-month transition period is long enough.
TGA Consultation
Pakistan’s DRAP Creates Guidelines on Conducting Clinical Trials
The Drug Regulatory Authority of Pakistan (DRAP) has published guidelines on the conduct of clinical trials. DRAP’s guideline covers many topics specific to the conduct of studies in Pakistan, such as explanations of the roles of different organizations and how to apply to run clinical trials.
In the guidelines, DRAP provides definitions of clinical trial terms, which follow harmonized global standards, and they cover topics specific to Pakistan. DRAP wants sponsors or principal investigators to send requests to run clinical trials to its Division of Pharmacy Services and will take 60 to 90 days to review applications.
To ensure adherence to good clinical practices, DRAP may perform inspections before and after a trial gets underway. If DRAP receives complaints or reports of unexpected adverse reactions, it may conduct unannounced inspections at short notice.
Principal investigators have seven calendar days to report serious adverse events to DRAP and must inform the sponsor immediately. DRAP wants sponsors to keep detailed records of all adverse events and share them with the Pakistan National Pharmacovigilance Centre along with the clinical trials report.
Once a trial is complete, the investigator and sponsor need to archive all documents related to the study and retain them for at least five years. DRAP wants written notice of document destruction.
DRAP Guidelines
Malaysia’s MDA Posts Draft Guidance on Importing Devices for Re-Export
Malaysia’s Medical Device Authority (MDA) has published draft guidance on importing products for re-export. The draft guidance follows the publication of the Medical Device Exemption Order 2019, which freed some importers from the need to register their products.
Typically, a company that imports a medical device into Malaysia needs to register the product under the Medical Device Act 2012. However, under the 2019 exemption order, that requirement does not apply to companies that bring medical devices into Malaysia with the sole purpose of exporting them to another country.
The draft guidance sets out the process companies need to go through to be exempted from the registration requirements. MDA wants applicants to complete a notification form, gather associated documents and submit the package 30 days before they plan to import their first shipment. Applicants will have 30 days to provide any additional information or materials requested by MDA.
Organizations covered by the exemption also have ongoing reporting requirements. At the end of the first quarter of every year, re-exporters must file details of the numbers of products they shipped in and out of Malaysia.
If an organization has imported more devices than it has exported, it will need to make an additional request covering the products that are still in Malaysia. MDA will give organizations that fail to put in a request three months to either export the devices or dispose of them locally.
Draft Guidance
Former Chinese Regulatory Chief Jailed for 16 Years Over $3M in Illegal Payments
A court has sentenced the former deputy head of the Chinese food and drug administration to 16 years in prison, according to state media outlet Xinhua. Wu Zhen received the sentence for allegedly illegally accepting $3.1 million in money and goods in return for help with approval and employment.
Chinese authorities targeted Wu in the wake of the scandal that engulfed Changchun Changsheng Biotechnology, a vaccine manufacturer accused of fabricating records. The investigation led to the identification of illegal payments that Wu allegedly accepted between 1996 and 2018.
The court fined Wu around $140,000 and confiscated his illegal properties.
India’s NPPA Orders Big Pharma Companies to Continue Selling Discontinued Drugs
India’s National Pharmaceutical Pricing Authority (NPPA) has ordered several large pharmaceutical companies to continue supplying medicines they want to discontinue. The requests affect Indian units associated with Abbott Healthcare, Bayer and Sanofi.
In each case, the company put in a request to discontinue a scheduled formulation only for NPPA to push back against the proposals. After discussing the requests at a recent meeting, NPPA told each company to continue supplying the affected medicines for 12 months after the intended date of discontinuation.
NPPA’s desire to keep the products on the market reflects concerns that the discontinuations will stop patients from accessing the medicines. Abbott, for example, has a 98% share of the market for leprosy drug clofazimine, according to NPPA. As such, NPPA thinks “sudden discontinuation could lead to shortages.”
Sanofi and Bayer, through its joint venture with Zydus Cadila, hold smaller shares of the markets they want to exit but are still important enough players for NPPA to move to defer their discontinuations.
Meeting Minutes


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