Asia Regulatory Roundup: Industry respondents urge TGA to align with international software regulations

Respondents to a consultation by Australia’s Therapeutic Goods Administration (TGA) on the scope of regulations governing software as a medical device (SaMD) offered broad support for the regulatory scheme and the concept of carving out certain products to avoid undue regulatory burden, the administration reported on 15 June.
 
TGA held a consultation on the topic earlier this year, specifically to gather feedback on the types of software-based products that should and should not be covered by the regulatory framework. The call for feedback followed a 2019 consultation that TGA felt “indicated that there was confusion over what was considered a medical device.”
 
In preparing the latest consultation, TGA reviewed how other regulators around the world define what software should be covered by medical device regulations. TGA identified “considerable alignment” between the different regulatory frameworks and said it wanted to “align internationally where appropriate.”
 
The aspiration to align internationally received broad support from industry respondents, including AbbVie Party Ltd. However, AbbVie also identified certain areas in which TGA risks deviating from the approaches of its international peers, leading the company to caution against veering away from harmonized definitions and policies.
 
TGA did not refer directly to AbbVie’s concerns in its summary of the responses. Rather, the administration noted that details still need refining. TGA noted calls for further clarifications of definitions and the “shared understanding of risk and how it may inform a carve-out.”
 
Unanswered questions include those regarding the oversight of products deemed to be exempt from the regulations. TGA received feedback that it should continue to have some regulatory oversight of the exempt products “unless risks are well understood by the users.”
 
AbbVie Feedback, TGA Response
 
CDSCO shares guidance BA-BE studies during pandemic
 
New regulations from India’s Central Drugs Standard Control Organization (CDSCO) require sponsors of bioavailability and bioequivalence (BA-BE) studies to follow good clinical practices and otherwise comply with certain standards during the COVID-19 pandemic. CDSCO accepts that the pandemic and government efforts to control it may make it harder for sponsors to comply with those standards for a variety of reasons.
 
CDSCO cited difficulties maintaining “complete adherence to the approved protocol, regulatory provisions/procedures and applicable guidelines” in relation to various study activities as part of the problem. Stakeholders have also told CDSCO that the procedures subjects and staff need to follow in screening participants, testing medicines and otherwise conducting the study may be affected by the outbreak.
 
Protocol amendments and changes to procedures may be needed to address “unavoidable circumstances” and to ensure the safety of study subjects, according to CDSCO. Before taking an action, the agency wants the sponsor and study site to assess the effect of the options available to them on the rights, safety and wellbeing of subjects, and on the integrity of the study data.
 
Sponsors should keep complete records of changes they make and the reasons for the actions. The new procedures adopted in response to the unavoidable circumstances must be in accordance with the requirements that apply to BA-BE studies run in India.
 
CDSCO Notice
 
Malaysia’s MDA delays medical device advertising regs
 
The Malaysian Medical Device Authority (MDA) has delayed the implementation of advertising rules by 18 months. MDA pushed back the deadline after identifying “implementation issues that require more time to be resolved.”
 
In September, the Malaysian Minister of Health signed off on regulations prohibiting the promotion of medical devices without MDA approval. Under the terms of the regulations, companies will have to send a copy of the proposed advertisement to MDA with a processing fee. The regulations support prison sentences of up to two years for people who advertise medical devices without approval.
 
Malaysian authorities originally planned for the regulations to take effect on 1 July 2020. However, with weeks to go before the deadline, MDA has identified implementation issues that will take time to resolve. MDA is yet to share details of the nature of the implementation issues. Implementation is now slated for the end of 2021.
 
MDA Notice, Advertising Regulation
 
TGA creates streamlined process to ease transition to new labelling rules
 
A streamlined process from TGA aims to help prescription drug manufacturers that are struggling “due to the pressures of COVID-19” to transition to new labelling requirements by the start of September.
 
In 2016, TGA established a four-year transition period for its new standard for prescription medicine labels to enable manufacturers to adapt to changes such as the addition of a dispensing label space, modifications to the size and placement of the name of the active ingredient and restrictions on the use of graphics.
 
Despite the long lead time, TGA has received reports that companies “are experiencing difficulty introducing TGO 91 assessed labels into their manufacturing process.” TGA attributed the difficulties to COVID-19.
 
To help those companies hit the deadline, TGA will start offering a streamlined section 14 process in July. TGA will make decisions on applications submitted under the new process within five days of receiving the required fee.
 
The streamlined process is available only to certain companies. Companies must be using labels that comply with the outgoing TGO 69 regulations, have received approval for labels assessed against the new TGO 91 rules, pay via credit card and use a new streamlined consent form. TGA will make the new form available soon.
 
Appropriate applicants need to provide details of batch numbers or production dates for the affected goods. TGA wants companies that submit production dates to provide a rationale for the selected period.
 
TGA Notice
 
Philippine FDA urges ‘extreme caution’ when using the antiviral favipiravir
 
The Philippine Food and Drug Administration (FDA) has urged healthcare providers to take “extreme caution” when using favipiravir, based on evidence from animal studies of the teratogenic effects of the antiviral.
 
Favipiravir is approved to treat COVID-19 in China, Italy and Russia. The FDA notice does not refer to the use of the drug in COVID-19, but the agency did include the alert in its roundup of actions it has taken in relation to COVID-19.
 
In the notice, FDA advises physicians to perform a pregnancy test “in women with child-bearing potential” before administering favipiravir. Women taking favipiravir should use contraception while on the drug and over the seven days following their final dose. Because favipiravir is distributed via sperm, the advice applies to men as well.
 
After prescribing favipiravir, FDA wants physicians to monitor for increased blood uric acid, diarrhea, decreased neutrophils and elevated liver enzymes.
 
FDA Notice
 
Other News:
 
China’s Center for Drug Evaluation (CDE) is seeking feedback on guiding principles for the development of pediatric medicines. CDE is accepting feedback on the draft guidance for one month. CDE Notice (Chinese)