Asia-Pacific Roundup: China’s NMPA updates regulations to encourage drug research, innovation

China has updated its drug regulations, leading the National Medical Products Administration (NMPA) to set out its areas of focus under the new framework.

NMPA said goals of the revised regulations include encouraging drug research and innovation. Reflecting that objective, the Chinese regulator plans to increase support for drug research and innovation while improving the quality and efficiency of drug reviews and approvals. The steps are intended to accelerate access to new medicines to benefit patients and support the competitiveness of the pharma industry.

The agency plans to enhance regulatory capacity to improve the efficiency of regulation. Under that part of the plan, NMPA will develop its workforce, innovate regulatory methods, and optimize the regulatory system. The to-do list includes improving regulatory coordination across the drug life cycle.

Other parts of the revised regulations seek to provide a “solid legal guarantee for high-level drug safety and the high-quality development of the pharmaceutical industry,” NMPA said. That focus led NMPA to commit to accelerating improvement of supporting systems and the legal framework for drug regulation.

“Based on the key systems defined in the regulation, the NMPA will coordinate the formulation and revision of supporting regulatory documents and technical guidelines, refine specific management requirements, and further implement the stipulations of the regulations to create a more integrated, optimal, scientific, and holistic legal system for drug regulation,” NMPA said.

Effective implementation of laws and regulations is on the agenda, too, with NMPA seeking to achieve that objective through policy publicity and interpretation, training, and instruction. The agency wants to ensure there is a thorough understanding of the new regulations.

Companies that fail to adapt to the updated regulations could face sanctions. NMPA wants to strengthen enforcement of the drug regulations, strictly implement drug safety responsibilities, and reinforce quality control across the product life cycle. Enhanced surveillance and inspection in key areas and a crackdown on drug-related illegal activities are part of the strategy for ensuring drug safety.

Press Release

Australia’s TGA seeks feedback on communicating medical device supply disruptions

The Therapeutic Goods Administration (TGA) is running a consultation into ways to improve the sharing of information about disruptions to the supply of medical devices in Australia.

Australian legislation limits when TGA can share information with external stakeholders other than the manufacturer or the sponsor of a medical device. While the law allows the agency to share information in certain situations, officials see value in extending the flexibility to include details of supply disruptions and device performance concerns.

TGA has proposed two options for releasing information about supply disruptions. One option is for TGA to share information on its website, much like it already does for drugs via its shortage report database.

The other option is for TGA to release information to specific stakeholders that can advise on the supply disruption, either by identifying devices that could be suitable substitutes or by taking steps to mitigate the impact on patients. Under that option, TGA would continue to withhold information about supply disruptions from the public but share details with groups including professional bodies as needed.

TGA wants to know if stakeholders support its plan to release information to manage supply disruptions and, if so, whether it should limit the releases to specific groups. The releases could include information that is not publicly available, such as the product code, reason for shortage, and details of alternative devices. TGA has asked whether it should give affected sponsors a chance to comment on its releases.

The agency is seeking feedback on the proposals until 20 February.

TGA Notice

Japan’s PMDA orders manufacturers of blood glucose meters to update package inserts

The Pharmaceuticals and Medical Devices Agency (PMDA) has asked manufacturers of blood glucose meters to add information about the potential for false high values to their Japanese package inserts.

PMDA issued the request after assessing the implications of a warning about drugs containing the chemotherapy drug hydroxycarbamide as the active ingredient. The warning stated that blood glucose measurement results may show results higher than actual values when people are taking the medicines. Falsely elevated blood glucose results could lead to hypoglycemia if relied on to dose insulin.

The risk prompted PMDA to ask manufacturers of various types of blood glucose meters to self-inspect their package inserts and make any necessary changes. PMDA asked manufacturers to confirm the drug may affect the results of their tests and, if it does, check if their package inserts reflect the risk. The agency has suggested text for manufacturers of medical devices and in vitro diagnostics to add to inserts.

Companies that need to add information to their package inserts should make the changes promptly, PMDA said. Manufacturers that have not completed the changes by 6 February should send a status report to PMDA. Companies with package inserts that already include information equivalent to PMDA’s suggested text do not need to update their documents.

PMDA Notice

Hong Kong secures ISO certification to lay foundation for creation of medtech regulator

Hong Kong’s Medical Device Administrative Control System (MDACS) has received an international quality standard.

MDACS, part of the Department of Health involved in medical device regulation, was awarded the 9001:2015 quality management systems certificate. The International Organization for Standardization (ISO) certificate is a widely adopted quality improvement framework designed to help organizations establish consistent procedures.

Hong Kong has secured ISO certification for MDACS, which lists more than 8,900 medical devices, as it prepares to establish the Centre for Medical Products Regulation (CMPR). Ronald Lam, Hong Kong’s Director of Health, said the certification will encourage more companies to voluntarily list their medical devices with MDACS and help facilitate a smooth transition to the CMPR era.

“Legislative proposals are expected to be submitted to the Legislative Council this year,” Lam said. “Under the new framework, all medical devices supplied in Hong Kong will require registration unless exempted, ensuring compliance with relevant safety, quality, and performance standards.”

Press Release

PMDA shares advice on developing IgA nephropathy medicines for the Japanese market

Japan’s PMDA has published guidance on evaluating the efficacy of treatments of the kidney disease immunoglobulin A (IgA) nephropathy.

As part of its series of early consideration documents, PMDA has advised developers of treatments for IgA nephropathy with mild-to-moderate renal dysfunction. The agency said Japanese guidelines advise sponsors to track changes in estimated glomerular filtration rate (eGFR) for at least two years for the primary endpoints of their trials. Both eGFR slope and change in eGFR from baseline are acceptable.

However, PMDA noted a shift to using the urine protein-to-creatinine ratio (UPCR) after nine months to predict eGFR after two years. Planned and active late-phase trials and published literature reflect the shift. It may be possible to demonstrate a certain level of efficacy using UPCR, the agency said.

Sponsors that demonstrate a certain level of efficacy and safety may be eligible for conditional approval in Japan. PMDA is open to using the pathway because of the unmet need in the type of kidney disease.

PMDA Guidance

Other News:

TGA has approved lenacapavir for pre-exposure prophylaxis (PrEP) for HIV. The drug, which Gilead will sell as Yeytuo in Australia, is an HIV-1 capsid inhibitor that is injected every six months to reduce the risk of sexually acquired disease. Traditional PrEP drugs are taken orally daily. TGA Notice

Asia-Pacific Roundup: China’s NMPA updates regulations to encourage drug research, innovation

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