Asia-Pacific Roundup: India's CDSCO seeks feedback on medical device software regulation
India’s Central Drugs Standard Control Organization (CDSCO) has released draft guidance on medical device software for consultation.Software is regulated under India’s Medical Devices Rules. CDSCO has identified a need to clarify aspects of how the regulations apply to software. The draft guidance is intended to provide specific requirements and align India’s regulation of software with globally harmonized practices.
CDSCO has defined and differentiated between Software in a Medical Device (SiMD) and Software as a Medical Device (SaMD). SiMD is embedded software or firmware that drives a hardware device. SaMD is standalone software with a medical purpose that runs on general-purpose hardware. The agency has proposed excluding some software from device regulations.
Under the draft guidance, CDSCO will automatically assign SiMD to the same risk class as the associated hardware device. The classification of SaMD will depend on the intended use of the device.
Software used to treat or diagnose a critical condition will be in Class D, the highest-risk category. Devices used to inform the management of non-serious conditions will be in Class A, the lowest-risk category. CDSCO has provided a table showing the characteristics that will lead to devices being categorized between Class A and Class D.
The risk categories will inform how CDSCO regulates the devices. State-level authorities will grant manufacturing licenses for Class A and Class B devices, while the central authority will handle higher-risk Class C and D software.
CDSCO has proposed a framework for managing updates to software, which are subject to different development cycles than physical devices. The agency’s definitions of minor and major changes will enable companies to notify it of fixes and patches that do not affect the intended use, safety, or performance of a device. Prior approval will be required for major changes.
The draft also outlines a framework for pre-defining certain changes, like the US Food and Drug Administration does with Predetermined Change Control Plans. India’s Algorithm Change Protocol (ACP) will enable companies to pre-define processes for retraining algorithms and updating software. Companies can make changes per the approved ACP without applying for a license, provided the updates do not significantly change the use or risks.
CDSCO is accepting feedback on the draft for 30 days.
Draft Guidance
India creates portal for monitoring high-risk solvent quality and supply
India has created a digital monitoring system for high-risk solvents in response to contaminated cough syrups linked to the deaths of children.
At least 24 children died recently after taking a cough syrup made in India, adding to hundreds of deaths globally in similar incidents in recent years. CDSCO initially responded to the recent deaths by ordering all drug batches to be tested before being released to the market.
The agency began the next phase of its response last week by adding digital solvent monitoring capabilities to the One Nation One Drug Licencing System (ONDLS). The monitoring system applies to 10 high-risk solvents such as glycerin, propylene glycol, maltitol, and sorbitol.
Producers of pharma-grade solvents must obtain a manufacturing license through the ONDLS portal. Companies that already hold manufacturing licenses must register and submit data through the portal.
CDSCO has asked solvent manufacturers to upload details of each batch they make, including the quantity and certificate of analysis. The agency wants its regional offices to ensure that only batches that comply with requirements imposed by the monitoring system come to market.
Regulators published details of the system the day after Reuters reported how a World Health Organization (WHO) official views India’s response to the contaminated cough syrups. The official said India has “made some strides” by requiring medicines to be tested before export but warned that the country needs to do more to ensure the quality of drugs used domestically.
CDSCO Notice
Chinese and Brazilian regulators vow to enhance drug review collaboration
The commissioner of China’s National Medical Products Administration (NMPA) has met with Brazilian officials to discuss cooperation between the countries.
Chinese and Brazilian leaders agreed to deepen their health cooperation. Shared objectives include enhancing collaboration on drug review and regulatory coordination and promoting exchanges between the two countries’ pharma industries. The two sides framed the planned cooperation as a way to ensure medical innovations reach patients in both countries.
Commissioner Li Li used the meeting to outline NMPA’s approach to drug regulation. NMPA said Li discussed China’s prioritization of drug quality and safety in recent years and its promotion of scientific, rule-based, international, and modern regulations.
Brazil’s engagement with China follows the South American country’s work to reform drug approvals. The reforms are intended to promote the growth of the Brazilian pharma industry.
Press Release
Philippine FDA confirms deadline for compliance with ICH E2B format
The Philippine Food and Drug Administration (FDA) has reminded marketing authorization holders (MAH) of an upcoming deadline.
From the end of 2025, FDA expects all MAHs to fully comply with new electronic submission requirements. MAHs will need to submit Individual Case Safety Reports (ICSRs) in the ICH E2B format. FDA set the deadline in guidelines it released in February 2020.
With the deadline approaching, FDA has reminded MAHs of the change to the ICSR submission requirements and directed them to resources to support compliance. FDA is offering enrollment and access to the VigiFlow Industry eReporting tool, a web-based application that is designed to simplify and standardize the submission of files that comply with ICH E2B.
FDA said the tool is particularly relevant to MAHs that are facing challenges in establishing their own E2B-compliant systems. The agency is offering help starting VigiFlow to companies that need further assistance.
FDA Notice
Head of Australia’s TGA elected chair of international regulatory coalition
The International Coalition of Medicines Regulatory Authorities (ICMRA) has named a leading Australian regulator as its next chair.
ICMRA members elected Tony Lawler, the head of Australia’s Therapeutic Goods Administration (TGA), to serve a three-year term as chair. The coalition brings together more than 40 international medicines regulators to support objectives including encouraging collaboration and harmonization.
Lawler will replace Emer Cooke, the executive director of the European Medicines Agency (EMA), as chair of ICMRA. Cooke took up the post in November 2020.
Lawler’s election ends years of European leadership of the organization. Guido Rasi, then the executive director of EMA, was chair of ICMRA in 2019 and 2020. Before that, the UK Medicines and Healthcare Products Regulatory Authority’s Ian Hudson served a three-year term at the coalition.
TGA was one of eight founding members that created ICMRA in 2013.
Press Release
Other News:
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is investigating potential quality and efficacy concerns with Sandoz’s Estradot patches. The product is a hormone replacement therapy used to relieve menopausal symptoms. Consumers have reported the return of menopausal symptoms and issues with patch adhesion. Medsafe’s initial investigation found no product quality issues that explain the reported issues with adhesion and efficacy. Medsafe Notice
TGA has shared details of planned changes to its website. Seeking to improve the experience of industry users, the agency is adding a section to make it easier to access its business services. TGA is also combining two sections on its regulations and organizing the content by product type. TGA Notice
Saudi Arabia’s Saudi Food & Drug Administration (SFDA) has become a full member of the International Coalition of Medicines Regulatory Authorities (ICMRA) after participating as an associate member since 2020.
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