Asia-Pacific Roundup: India proposes notification system for starting clinical trials for certain drugs

India is proposing to allow sponsors of some clinical trials to start studies after notifying authorities, rather than requiring them to seek approval before initiating enrollment.

The change to a “notification/intimation system” means only sponsors developing “a small category of high-risk category drugs” will need to file for approval from the central licensing authority. The category of excluded products includes “the new drug and Investigational new drug of category of sex hormones, cytotoxic, beta lactum, biologics with live microorganism and narcotics and psychotropic drug[s].”

Developers of all other drugs will be able to submit an online notification and start making their product for use in clinical trials. Manufacturers of excluded drugs will still benefit from the changes, with Indian authorities planning to reduce the time for processing applications from 90 days to 45 days.

The changes are part of a broader set of planned revisions to the New Drugs and Clinical Trials Rules, 2019. Indian authorities are also planning to change the rules on running bioavailability and bioequivalence (BA/BE) studies, including eliminating the current license requirement for certain categories of BA/BE studies.

Authorities plan to end the license requirement for sponsors of “single-dose, two-period, two-sequence, two-treatment, bioavailability or bioequivalence studies in normal healthy adult human volunteers (for export purpose only), of oral dosage form of a drug.” The rule applies to drugs that are already approved in the US, European Union, Japan, Australia, Canada, or the UK and to studies of up to 48 samples.

Drugs in “cytotoxic, hormone, narcotic and psychotropic substances categories and not a drug of narrow therapeutic index or a drug having highly variable pharmacokinetics” are excluded. The license requirement will continue to apply to sponsors of BA/BE studies of excluded products. All other sponsors will be able to file a notification online, including ethics committee approval in their submissions.

The Indian Health Ministry said the reforms are expected to significantly reduce the timelines for processing applications and reduce the number of license applications by approximately 50%. Officials said the changes will “facilitate quicker initiation of BA/BE studies, testing and examination of drugs for research, and reduce delays in the drug development and approval processes.”

Other anticipated benefits include the optimization of human resource use at CDSCO. Officials predict the optimization will enhance “the efficiency and effectiveness of regulatory oversight.” Ultimately, the goal is to increase the “attractiveness of India for clinical research thereby strengthening India’s position as a global hub for pharmaceutical research and development.”

The proposed changes are open for comment for 30 days.

Press Release

TGA seeks feedback on medical device reprocessing and remanufacturing in Australia

Australia’s Therapeutic Goods Administration (TGA) is running a consultation into guidance on regulatory requirements for reprocessing and remanufacturing medical devices.

TGA is seeking feedback from manufacturers and sponsors of reusable and remanufactured medical devices, and procurement teams, healthcare facilities, and healthcare professionals involved in acquiring and using reprocessed and remanufactured medical devices. Reprocessing covers maintenance such as cleaning. Remanufacturing significantly changes a device’s performance or safety specifications.

The consultation aimed at manufacturers and sponsors lists the regulatory pathways for different types of reprocessed and remanufactured devices. For example, when a facility remanufactures a device for internal reuse, the product is covered by the off-label clinical practice pathway. However, if the facility supplies a device to other users, a new Australian Register of Therapeutic Goods (ARTG) entry is needed.

“Healthcare facilities remanufacturing and reusing single use medical devices in-house are not ‘supplying’ the device (as the facility already owns it), and so no ARTG entry is required,” TGA said. “Such reuse is part of clinical practice, and associated risks are the responsibility of the facility and relevant health care professionals.”

The draft guidance features similar explanations for various types of reprocessing and remanufacturing of reusable and single-use medical devices. TGA has also addressed special cases, such as system and procedure packs and surgical loan kits.

The regulatory requirements for remanufactured products are “by and large” the same as for any other medical device, TGA said. Yet, TGA said third parties that perform remanufacturing may find it difficult to comply with the regulatory requirements.

TGA cited the need to provide evidence that the material used in the original manufacture of the device can withstand repeated remanufacturing as an example of a requirement that remanufacturers may find it hard to meet. Complying with the requirement may necessitate access to information, possibly including intellectual property, that is held by the original manufacturer, which has no obligation to share the data.

TGA is seeking feedback until 13 October.

TGA Consultation

India changes drug marketing code to address industry complaints about admin burdens

India’s Department of Pharmaceuticals (DoP) has changed the drug and medical device marketing codes to address calls to reduce the burden of compliance.

Both updates affect the submission of data on the value of free samples provided to healthcare practitioners. DoP said it made changes to the drug marketing code after industry groups told it the old requirements imposed “significant administrative burden in terms of duplication of efforts and compliance.”

The industry sought “simplification of the reporting form and requirements through submission to respective industry associations and the recording of the price for free samples as the average price charged to the stockist or immediate customer or the average price paid for the purchase of medicines for the same dosage form and strength on annual basis,” DoP said.

Similarly, the medical device industry has requested the simplification of the disclosure requirements. The feedback led government officials to change the section on free samples in the device marketing code. The device changes are in line with the revisions to the drug marketing code.

DoP Circular, More

CDSCO clarifies rules on seeking permission to manufacture new or investigational drugs

CDSCO has clarified what evidence companies need to submit when filing to study drugs that undergo certain types of genetic engineering.

The agency said approval from the Review Committee on Genetic Manipulation (RCGM) is not needed for certain categories of experiments. Yet, biopharma companies are still submitting a form for RCGM consideration to carry out R&D and including the corresponding approval letter when seeking CDSCO’s permission to make new or investigational drugs for use in clinical trials.

In response, CDSCO said Institutional Biosafety Committee approval should be accepted when a company is seeking approval to make a drug for use in a clinical trial. The rule applies to Category I and Category II genetic engineering experiments. Different rules apply to Category III experiments.

CDSCO Notice

Other News:

TGA has published a list of medical devices in the ARTG that feature artificial intelligence (AI) or machine learning technologies. This agency developed the list in response to stakeholder feedback requesting greater transparency about the use of AI in medical devices. TGA said the list may not include all devices in the ARTG that use the technologies. TGA Notice

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published its good manufacturing practice (GMP) annual report. PMDA said it conducted 131 on-site GMP inspections in its 2024 financial year. The agency performed more than 2,000 desktop GMP inspections over the same period. PMDA Report

Asia-Pacific Roundup: India proposes notification system for starting clinical trials for certain drugs

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