Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
Australia Seeks Input on How to Regulate Fecal Microbiota Transplantation
Australia’s Therapeutic Goods Administration (TGA) is seeking industry feedback on the regulation of materials used for fecal microbiota transplants. TGA initiated the consultation to answer fundamental questions about fecal transplant materials, such as whether they are biologicals, to help it develop a new regulatory scheme.
TGA classes fecal materials as therapeutic goods, since they are used in the treatment or prevention of human diseases. The fecal matter is taken from a donor, processed and introduced into the bowel of another person to alter the microbiome of their gastrointestinal tract.
Currently, fecal microbiota transplant materials are not regulated at a national level in Australia but, with the substances posing some risks and use of the procedure rising, TGA thinks that may need to change. However, TGA is yet to decide whether to class all of the materials as biologicals, as they contain human cells, or treat them differently and adopt a lighter regulatory regime.
The consultation paper seeks to move TGA closer to an answer by putting four options to the sector. These options range from treating all fecal transplant materials as biologicals and regulating them accordingly through to self-regulation by the sector.
If TGA regulates the materials under its biologicals framework, it will treat them as either Class 2 or 3 substances depending on the extent to which they are processed. The categorization will have some effect on how a product is regulated, but all materials will be subject to many of the same rigorous requirements.
Under the biologicals framework, all fecal material production and testing facilities would need to be good manufacturing practice (GMP) licensed. Manufacturers would also need to submit dossiers to get their products in the Australian Register of Therapeutic Goods (ARTG).
Recognizing that regulating the materials as biologicals would force significant changes on the sector, including major financial implications, TGA also proposed three other options that may offer a better balance between safety and practicality. Two of these options leverage the biologicals framework but also feature mechanisms to free some materials from more burdensome regulations.
One option is to class minimally manipulated materials that are manufactured and used in the same hospital as Class 1 biologicals. Operations handling Class 1 materials would not need to be licensed by TGA, but many other products would still be subject to rigorous regulations.
The other two options proposed by TGA offer lighter regulations. One option would exempt materials from some or all TGA regulations, while applying the biological framework to products that do not meet the criteria for exclusion. The final option is for TGA to leave the industry to self-regulate through the development of standards and establishment of a facility accreditation scheme.
TGA’s consultation paper identifies shortcomings with all of the options, from the cost of the full biological proposal through to the risk that the industry will fail to sufficiently assess materials that undergo substantial manipulation.
The agency is accepting feedback until 15 March.
China’s Communist Party Expels Former Senior Vaccine Regulator for Corruption
The Communist Party of China (CPC) has expelled a former deputy director of the China Food and Drug Administration (CFDA). Wu Zhen was ousted from the party following an anti-corruption investigation that began in the wake of the vaccine scandal that roiled China last year.
According to the Chinese government, Wu took bribes, engaged in nepotism, accepted offers of trips and invitations to banquets and otherwise abused his position at the Chinese drug regulator. China’s Central Commission for Discipline Inspection and the National Supervisory Commission made the allegations following an investigation that began in August.
In addition to expelling Wu from the CPC, China has canceled his benefits and confiscated illicit gains. The investigators have shared evidence of criminality with prosecutors for further examination and potentially criminal charges.
Wu is one of four CFDA officials whose cases were transferred to prosecutors this week. A further 80 provincial and local officials from multiple government bodies also face punishment for their alleged roles in the vaccine scandal, which centered on the fabrication of records by Changchun Changsheng Biotechnology.
China has hit people inside and outside government with significant penalties for their part in the events. Changchun Changsheng received a $1.3 billion fine last year, and authorities banned some of its executives from working in the pharmaceutical industry.
(Chinese), Xinhua, The New Paper
TGA Adds Permitted Indications to Complementary Medicine Guidelines
TGA has updated its guidelines on the evidence requirements for listed complementary medicines. The revision brings the text into line with changes to the Therapeutic Goods Act passed last year, notably by adding details of the permitted indications introduced in the legislation.
Since March 2018, companies can only sell new listed medicines for use in certain permitted indications. A transition period gives manufacturers that brought products to market before the new rules came into force three years to adapt. Listed medicines sold for use in non-permitted indications will lose their ARTG listings in March 2021.
In light of the changes, TGA has updated its guidelines on the evidence developers of complementary medicines need to provide. The text now features examples and information on biomarkers that are consistent with the indications permitted by the latest legislation.
The new text, version 3.0, is the first major update since 2014 but is likely to be superceded in the near term. TGA left the evidence requirements unchanged in the latest version, choosing instead to focus on adapting it to the 2018 legislation, but it plans to tackle those topics soon. A broader review of the text is planned for this year to improve its clarity and usability.
CDSCO Pressures State Regulators to Enforce Licensee Data Upload Requirements
The Central Drugs Standard Control Organization (CDSCO) is pressuring state regulators to enforce its data upload requirements. CDSCO’s notice comes weeks after India told holders of licenses to make and sell drugs to upload their information to the Sugam online portal.
India wants to gather the data online to strengthen its drug regulatory system, improve transparency and accountability and increase access to medicines. To achieve that goal, CDSCO needs companies to comply with its request to upload data and, having seen the industry ignore similar requests in the past, wants its regional offices to contribute to the effort.
“State drugs controllers are requested to take necessary action and direct ... manufacturers to upload the data,” CDSCO wrote in a notice sent to its officials and pharma trade groups.
CDSCO also wants the state officials to verify data uploaded by manufacturers. The legislation that mandates the uploading of the data makes no mention of a deadline for doing so, stating only that the information should “be updated from time to time.”
has passed legislation exempting some sterile solutions from certain licensing requirements. The exemption covers single-use, 100ml parenteral products that are intended for export. As a result of the legislation, manufacturers of these products are exempt from the need to obtain a Form 28D or 28DA license from the central approving authority. Legislation
The New Zealand Medicines and Medical Devices Safety Authority
(Medsafe) has shared a recall notice about Medtronic
’s Adapta dual chamber pacemakers. Medtronic initiated the recall after learning of a circuit error that affects certain devices. Medsafe Notice