Asia-Pacific Roundup: PMDA smooths overseas biotechs’ path to Japan with one-stop service platform
The Pharmaceuticals and Medical Devices Agency (PMDA) is coordinating with other Japanese bodies to offer a one-stop service platform for biotechs that want to run clinical trials in the country.PMDA has begun courting overseas emerging biotechs in recent years to tackle drug lag and loss, terms for products that either launch in Japan long after other countries or never reach the market. Initiatives like setting up overseas PMDA offices are part of the agency’s response to the problem.
Japan’s Ministry of Health, Labour and Welfare (MHLW) has taken the lead on the latest initiative. MHLW has set up ENSEMBLExJ, a one-stop service office that will consult and coordinate to enable companies to run clinical trials in Japan. The country’s National Centers will implement the project in collaboration with Clinical Research Core Hospitals.
PMDA will consider providing priority consultations to companies developing candidates that are eligible for ENSEMBLExJ. Eligibility for priority consultation is limited to drug or regenerative medicinal products that address a high medical need and are being considered for clinical development in Japan. PMDA and ENSEMBLExJ will assess medical needs based on existing guidance for handling priority reviews.
The organizations will also jointly decide on a case-by-case basis whether companies can submit their consultation documents in English. The English-language submission option is aimed at companies that lack a Japanese subsidiary and meet other criteria, such as having annual global sales of less than $500 million or annual R&D costs of less than $200 million.
PMDA is advising companies that want a priority consultation or intend to file English-language paperwork to consult with ENSEMBLExJ in advance.
PMDA Notice
Singapore’s HSA finalizes sandbox for AI-based medical devices after consultation
Singapore’s Health Sciences Authority (HSA) has finalized the scope and requirements of its sandbox for artificial intelligence technologies after reviewing responses to a public consultation.
The potential for sandboxes to give companies a secure, controlled environment in which to generate evidence about their AI technologies has attracted regulators including the UK Medicines and Healthcare products Regulatory Agency. HSA signaled interest in the model when it ran a public consultation last year. The agency provided an update in the initiative last week.
“The proposed sandbox seeks to strike a balance between ensuring appropriate regulatory oversight and fostering healthcare innovation. In particular, the controls for the sandbox have been developed, taking into consideration the existing cyber and data security safeguards that all public healthcare entities are already required to comply with,” the agency said.
HSA has limited its sandbox to Class A and B software as a medical device (SaMD) products developed by selected public healthcare entities for use in public healthcare. The class restriction reflects HSA’s focus on devices with lower potential risks to patients.
A senior clinician at a public healthcare institution must oversee the design, validation, and output of the SaMD. The CEO or chairman of the medical board at the institution must endorse the program. HSA put the requirement in place to ensure senior leadership is accountable and aware of AI-SaMDs deployed at their institutions.
HSA said the sandbox initiative is “starting with the public healthcare sector to gather valuable insights.” The agency will consider extending the scope. HSA will also use outcomes from the sandbox to inform next steps such as how the controls are calibrated. The agency’s goal is to create a comprehensive framework that supports innovation while ensuring the safe and effective use of AI in healthcare.
HSA Notices
Malaysia’s NPRA sets testing requirements for ethylene and diethylene glycol
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has shared excipient testing requirements to manage the threat posed by certain high-risk ingredients.
In recent years, health authorities have linked the toxic contaminants ethylene glycol (EG) and diethylene glycol (DEG) to the deaths of hundreds of children globally. NPRA is among the agencies to receive alerts about the detection of EG or DEG in their jurisdictions. With the World Health Organization encouraging agencies to mitigate the risk, NPRA has taken steps to ensure EG and DEG levels are below 0.1%.
The agency has imposed requirements on manufacturers of oral liquid dosage forms that use high-risk excipients such as propylene glycol and glycerin. To ensure medicines contain acceptable levels of EG and DEG, companies must test every batch of either the high-risk excipients or the finished products.
Importers are responsible for ensuring the manufacturer tests either the excipients or the finished product. Again, every batch must be tested. Private laboratories that are not recognized by NPRA can perform the tests. NPRA is advising companies that outsource the work to check that the laboratory has validated testing methods for EG and DEG.
If tests uncover the contaminants in a finished product, the authorization holder must report the details to NPRA. The agency will require companies to submit a complete and satisfactory risk assessment and a corrective and preventive action plan before it allows new batches of the affected product to come to market. NPRA will recall products that are on the market and, if needed, review the drug’s license.
The agency will implement the testing directive on 1 April. Compliance with the rules will be voluntary during a one-year transition period. The requirements apply to pharmaceuticals, health supplements, and natural products.
NPRA FAQ, More (Malay)
Indian Pharmacopoeia Commission inks deals to strengthen quality assurance
The Indian Pharmacopoeia Commission (IPC) has moved to strengthen drug safety and quality assurance by forming memoranda of understanding with three organizations.
Building on agreements such as its three recent pacts with organizations in Nagaland, IPC has created frameworks for collaborating with the Goa State Pharmacy Council (GSPC), Quality Council of India (QCI), and HLL Infra Tech Services Limited (HITES). The agreements form part of a bid to bolster drug safety and quality while building capacity.
Working with GSPC, IPC plans to strengthen adverse drug reaction reporting (ADR) mechanisms under the Pharmacovigilance Programme of India and raise awareness of pharmacopeial standards. The next steps include forming and strengthening ADR monitoring centers and enhancing systematic reporting and documentation practices.
The QCI agreement supports cooperation in areas including pharmacovigilance awareness and initiatives aligned with national quality and safety objectives. IPC said the flexible, non-binding framework will facilitate project-based cooperation. The collaborators will undertake specific activities through mutually agreed work orders. IPC did not share further information about its agreement with HITES.
Press Release
Australia’s TGA raises concerns about increased risk of revision for ankle device
The Therapeutic Goods Administration (TGA) has raised concerns about an increased risk of revision for an ankle replacement system.
Citing data in the Australian Orthopaedic Association National Joint Replacement Registry, TGA said the Hintermann Ankle Replacement System is associated with a higher revision risk than other fixed and mobile bearing systems. Patients who receive the implant may be at a higher risk of requiring additional surgery, TGA said.
DT MedTech makes the H3 system for Actis Medical. Actis has asked healthcare providers to quarantine all unused H3 implants made by DT and monitor patients who have already received the device. Patients who develop symptoms such as new or worsening swelling should contact their healthcare provider. TGA is not recommending the removal of implants that are functioning well.
TGA Notice
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