Asia Regulatory Roundup: CDE posts draft guidance on SARS-CoV-2 antibodies

RoundupsRoundups | 05 May 2020 |  By 

China’s Center for Drug Evaluation (CDE) has released technical requirements for developers of antibodies against the pandemic SARS-CoV-2 coronavirus. The guidance provides advice on how to develop and manufacture antibodies capable of stopping the virus from entering cells.
Antibodies have emerged as one of the most keenly anticipated pharmacological responses to the coronavirus, reflecting experience with the modality and summer start dates for a clutch of assets that could ultimately be used to both treat and prevent infections. To support the progress of the candidates in China, CDE has drafted guidance discussing the steps companies need to complete and the regulations that apply to them.
The section on the research and development of anti-SARS-CoV-2 antibodies covers topics such as the selection of cell lines, early process development and the establishment of cell banks. CDE is open to developers taking shortcuts to save time, provided they take precautions to mitigate issues associated with the accelerated approaches.
For example, CDE thinks the use of a transient expression system or production of non-monoclonal cell populations can shave a month off timelines. However, CDE warns companies that opt for such a truncated approach need to pay attention to the potential for quality to vary from batch to batch.
CDE shared the guidance shortly after releasing a draft about running clinical trials during the pandemic. The guidance makes some of the same points as comparable documents posted by agencies in other countries, for example by permitting remote monitoring to take place when it is unsafe or impossible to visit clinical trial sites in person.
Another section of the guidance states that digital technologies make it possible to conduct virtual clinical trials that enable drugs to be studied despite the ongoing viral outbreak. The initiation of fully virtual or hybrid clinical trials may be part of the solution to the question of how to keep programs on track against the backdrop of prolonged disruption due to the coronavirus.
The guidance on trials during the pandemic is open for comment until 7 May. CDE is accepting feedback on the antibody guidance until 15 May.
CDE Guidance, More (both Chinese)
TGA pushes for additional screening of fecal transplants during pandemic
Australia’s Therapeutic Goods Administration (TGA) has asked providers of fecal microbiota transplant (FMT) products to take extra precautions to protect patients during the coronavirus crisis.
In March, the US Food and Drug Administration (FDA) shared the findings of studies that detected the SARS-CoV-2 virus or its RNA in the stool of infected patients, suggesting the coronavirus could be transmitted by FMT products. This week, TGA asked providers to add questions to their donor screening process to determine whether a donor is or has been infected with SARS-CoV-2. When feasible, TGA also wants providers to test donors, via stool sample or nasal swab, for SARS-CoV-2.
The goal of the extra steps is to identify and exclude donors who could put recipients of FMT at risk of contracting SARS-CoV-2. Even with those precautions in place, TGA wants providers to add details of the risk of SARS-CoV-2 transmission to the informed consent papers they give patients. 
TGA Notice
Panemic prompts CDSCO to extend expiration of WHO GMP certificates
India’s Central Drugs Standard Control Organization (CDSCO) has extended the expiration of good manufacturing practice (GMP) certificates by six months in response to the disruption caused by the COVID-19 pandemic.
The extension applies to companies that have a Certificate of Pharmaceutical Product (CPP) issued under the World Health Organization (WHO) GMP Certification Scheme that is due to expire between March and August 2020. Manufacturers in that position will benefit from a six-month extension. CDSCO described the extension “as per WHO GMP Certification guidelines.”
In granting the extension, CDSCO hopes to “maintain the continuity of essential activities by the pharmaceutical industry” at a time when global restrictions on travel and face-to-face interactions are making it harder to carry out a range of routine activities. The extension comes two years after the validity of CPPs was increased from two years to three years.
CDSCO Notice
‘Significant’ rise in hydroxychloroquine adverse events triggers warning in New Zealand
Sanofi has warned physicians in New Zealand of a “significant increase” in reports of serious and life-threatening adverse events linked to hydroxychloroquine, a disease-modifying antirheumatic drug (DMARD) being studied as a treatment for COVID-19.
In a letter shared by the New Zealand Medicines and Medical Devices Safety Authority, Sanofi said “there has been a significant increase in the number of reports of serious and life-threatening cases of QT prolongation, torsade de pointes, syncope, cardiac arrest and sudden death temporally associated with the concomitant use of hydroxychloroquine with other drugs known to prolong the QT interval, such as azithromycin.”
Sanofi is asking prescribers to “carefully” evaluate the off-label use of hydroxychloroquine, which the French drugmaker sells under the Plaquenil brand. Sanofi is calling for physicians to supervise patients who receive hydroxychloroquine in addition to other QT-prolonging drugs in hospitals and use the lowest dose possible of its product.
Sanofi Letter
TGA starts postmarket review of face masks amid increased demand
TGA has begun a postmarket review of face masks in response to concerns about the effectiveness of such products. The review will seek to confirm masks included in the Australian Register of Therapeutic Goods (ARTG) work and meet regulatory requirements.
As COVID-19 has spread and escalated, TGA has seen a “rapid increase” in demand for face masks. Manufacturers, many of which are based outside of Australia, have responded to the rise in demand by getting new face masks included in the ARTG. While that could help supply meet demand, it may also have created problems.
Some of the devices may not meet the definition of “medical device,” despite potentially being able to play a role in curbing the spread of the coronavirus. Such devices do not need to be included in the ARTG.
TGA’s postmarket review will assess whether face masks added to the ARTG meet the medical device definition. The agency will also assess whether the products work as intended.
TGA Notice
Other News:
TGA has reported a year-on-year decline in the number of major deficiencies identified during its pharmacovigilance inspections. In 2019, inspectors identified 41 major failings, down from 50 in the prior year. The decline reflects significant reductions in major deficiences related to the collection and collation of adverse drug reactions and ongoing safety evaluation. TGA Notice
China’s National Medical Products Administration (NMPA) has shared more information about its efforts to raise standards in the medical device supply chain. NMPA Notice (Chinese)


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