Asia-Pacific Roundup: CDSCO releases draft guidelines on good clinical practices for consultation

The Central Drugs Standard Control Organization (CDSCO) has begun a 30-day consultation into proposed changes to the good clinical practice (GCP) guidelines in India.

CDSCO has proposed adding 30 pages to the existing 121-page document. The organization said the text establishes principles “to support efficient approaches to study/research design and conduct” with an increased focus on technology.

“Innovative digital health technologies, such as wearables and sensors, may expand the possible approaches to study/research conduct,” CDSCO said. “Such technologies can be incorporated into existing healthcare infrastructures and enable the use of a variety of relevant data sources in clinical study/research.”

The draft establishes a definition for “data acquisition tool,” a term CDSCO uses to refer to paper and electronic tools designed to collect data and associated metadata according to the protocol. The definition covers technologies such as wearables. CDSCO has also proposed definitions for e-consent and decentralized clinical trials, which often use technology to replace site-based processes.

CDSCO also proposes adding a subsection on computerized systems to its discussion of the validation of electronic data processing systems. The new subsection, complemented by a new definition of “computerized systems validation,” says the sponsor is responsible for ensuring that expectations for computerized systems “are addressed in a risk proportionate manner.”

The expectations include creating documented procedures for appropriately using systems for data collection, handling, and management and maintaining security controls. Controls should include “user management and ongoing measures to prevent, detect, and/or mitigate security breaches,” CDSCO said.

CDSCO has also proposed significant changes to sections on quality assurance and ethics. The current document features four short paragraphs on quality assurance. CDSCO wants to retain most of that text and add new definitions of terms such as audit, risk identification, and risk control.

“The sponsor should adopt a proportionate and risk-based approach to quality management, which involves incorporating quality into the design of the clinical study/research (i.e., quality by design) and identifying factors that are likely to have a meaningful impact on participant’s rights, safety and well-being and the reliability of the results,” CDSCO said.

The organization has proposed rewriting large sections of the ethics guidance, including adding points on conflicts of interest, compensation for research-related harm, and privacy and confidentiality. The draft also features a rewritten subsection on compensation.

Other proposed changes include adding specific advice on studies involving medical devices, stem cells, and nanoparticles, an expansion to cover academic clinical research and discussions of topics such as marginalized communities, and sponsor oversight and monitoring.

Draft Guidelines

TGA seeks feedback on clarifying and strengthening the regulation of AI

Australia’s Therapeutic Goods Administration (TGA) has proposed changes to ensure the drug and device legislative frameworks align with proposed “guardrails” on the use of artificial intelligence (AI).

The Department of Industry, Science and Resources is leading the Australian government’s work on the safe and responsible use of AI. The department has proposed establishing guardrails on using AI in high-risk settings while allowing the use of the technology in low-risk settings under existing laws. The guardrails include strategies for regulatory compliance, risk management and human control.

In parallel, TGA is collecting feedback on plans to revise therapeutic goods legislation to reflect AI safety measures. The administration believes the regulatory framework already broadly aligns with the guardrails, but some changes may be needed.

TGA is seeking feedback on plans to update definitions that clarify responsibility for developing, deploying and using AI models and systems and to reclassifying certain medical devices. AI models that meet the definition of a medical device and are solely intended to provide a prediction or prognosis for a disease or condition are currently regulated as Class I.

“This is not considered appropriate in cases where this information is used to determine treatment plans or interventions which could have a significant and detrimental impact on patients if the prediction or prognosis is not accurate,” TGA said. The administration has proposed changing the rules to up-classify AI models depending on the severity of the target disease and other factors.

TGA also asked for input on whether the current essential principle on programmed or programmable medical devices addresses the risks emerging from the complexity of different subtypes of AI. The administration wants to know if additional provisions are needed to address specific technologies such as adaptive AI, generative AI and machine learning.

Other sections of the consultation address whether the existing exclusion of some software-based products from TGA oversight is appropriate in the AI era, the risks and advantages of international harmonization, and the merits of labeling products as “TGA approved.”

The feedback will inform a report to the Australian government. The report will identify areas where legislative changes may be considered to address the risks and leverage the opportunities associated with the increasing use of AI. Once the government reaches a decision, the feedback may support a “potential forward program of work for the TGA, which may include further consultation.”

TGA is accepting feedback until 13 October.

TGA Consultation

PMDA tests submission of new drug applications in English

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has begun accepting English-language applications for approval of new drugs in a trial intended to get products to patients sooner.

PMDA already allowed companies to submit parts 3, 4 and 5 of the common technical document in English. The test of allowing companies to submit the entire document in English is intended to “eliminate drug-lag/drug-loss and to make it easier for foreign companies to apply for marketing approval in Japan,” PDMA said.

The flexibility covers the entire document, including the written application for approval and the draft package insert, and applies to certain new ethical drugs and foreign companies without a Japanese corporation or office in Japan. PMDA said it could expand the scope of companies eligible for the option after considering the test’s results “in terms of needs, costs and other factors.”

PMDA Notice

India’s DoP publishes 2024 code for medical device marketing practices

The Department of Pharmaceuticals (DoP) has introduced a code for the transparent and accountable marketing of medical devices in India.

Through the Uniform Code for Marketing Practices in Medical Devices (UCMPMD), the DoP requires medtech companies to provide information about the distribution of samples and spending on activities such as continuing medical education. Companies must upload the information to the UCMPMD portal within two months of the end of each financial year.

The code limits the promotion of medical devices through evaluation samples and continuing medical education, for example, by prohibiting companies from running events in foreign countries. Other sections restrict the gifts, travel, and hospitality companies can provide healthcare professionals.

The UCMPMD establishes processes for lodging and handling complaints about code breaches, penalties for companies found guilty of wrongdoing and a procedure for appealing rulings.

DoP Notice

Asia-Pacific Roundup: CDSCO releases draft guidelines on good clinical practices for consultation

Related topics

Recommended content

Welcome to the new RAPS Digital Experience