Asia-Pacific Roundup: Japan’s PMDA seeks to curb medical accidents

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) released recommendations aimed at preventing medical accidents that include improving pharmaceutical warning labels and changing the thickness and color of certain syringes.

Recommendations related to pharmaceutical products center around improving warning labels for medicines in dosage forms that are prone to misuse. For example, some oral and topical preparations that are packaged in vials or ampoules may give the appearance that they are injections, and since a syringe is used to extract the medication from the container, there is a risk for mistaken injection, according to PMDA. To prevent this type of accident, PMDA recommends that the container be labeled “forbidden for injection” and a sticker with the label “no injection” be affixed to the syringe.

PMDA has also received reports of topical liquid preparations, such as athlete’s foot medicines, packaged in containers similar to eye drops being mistakenly administered into the eyes. As a result, athlete’s foot medicines should be packaged in containers of 10 mL or more, have a nozzle that is red, black or brown in color, and include a “do not put in eyes” label in a prominent location, according to the PMDA recommendations.

To prevent accidents related to medical devices, PMDA is planning to set standards for syringes used for collecting and administering liquids other than injections. The standards will call for making the syringe tip thicker and coloring it, as well as ensuring that these syringes cannot be physically connected to infusion lines.

PMDA notice

China collaborates with Vietnam, Thailand on drug regulation

China’s National Medical Product Administration (NMPA) recently sent a delegation to Vietnam and Thailand to sign memorandums of understanding around cooperation on the regulation of drugs, medical devices, and cosmetics.

“The drug regulatory authorities of China and those of Vietnam and Thailand have agreed to further strengthen communication and exchanges under the new regulatory cooperation framework, promote the high-quality development of the pharmaceutical industry and jointly safeguard public health and well-being,” China’s NMPA wrote in a statement.

While visiting Vietnam, the delegation discussed sharing regulatory experience around good manufacturing practices, drug inspections and quality control. In Thailand, the delegation discussed information exchanges, inspection cooperation and international coordination. The delegation also toured drug testing facilities and clinical trial sites in both countries.

NMPA press release

Hong Kong approves new drugs under accelerated pathway

The government of the Hong Kong Special Administrative Region (HKSAR) has approved two new drugs for registration under the “1+” regulatory pathway. The latest approvals are for new drugs in two different dosages for the treatment of extensive-stage small cell lung cancer.

The 1+ pathway was implemented in November 2023 to ease the registration process for new drugs used in the treatment of life-threatening or severely debilitating diseases. It allows for drugs to be approved for registration based on local clinical data and approval from one reference drug regulatory authority rather than two. Since 1 November 2024, the 1+ pathway has been expanded to include all new drugs, biologics, vaccines and advanced therapy products.

Since the 1+ pathway went into effect, nine new drugs have been approved using the mechanism. Interest in the pathway has been even higher. The Department of Health has received more than 350 enquiries from more than 90 pharmaceutical companies about the program.

“The ‘1+’ mechanism serves to attract more new drugs from different parts of the world seeking approval for registration in Hong Kong, giving patients more choices and further strengthening the local capacity for drug evaluation while enhancing the development of relevant software, hardware and expertise with a view to progressing towards ‘primary evaluation,’” the HKSAR said in a statement.

HKSAR press release

Australia moves toward gender parity in medical research funding

Men and women lead chief investigators submitted a similar number of grant applications and had similar funded rates for Australia’s Medical Research Future Fund (MRFF), according to a report on competitive grant opportunities between 2017 and mid-2024. The MRFF provides government funding for research translation.

However, men who were lead chief investigators received a larger proportion of the funding (51%) than women (43%). “This was likely due to the higher amounts of funding applied for and received by men, and the large gender disparity in the earliest years of the MRFF,” the report stated.

There were more applications from women lead chief investigators than men in 2022-23, continuing a trend that began in the previous fiscal year. In 2022-23, women lead chief investigators also had a higher funded rate than men. While men lead chief investigators still received a higher proportion of funding than women, the gap was the smallest it has been since MRFF competitive grant opportunities became available in 2017.

For the first time, there is sufficient data to report on funded rates for non-binary researchers. In 2022-23, there were 31 non-binary chief investigator applicants, and they had a funded rate of 51.6%, higher than either men or women, though the report notes that this was based on a small number of applicants.

“Although some of the increase in the number of non-binary applicants can be attributed to the opening of grant opportunities especially relevant to non-binary people as a health priority population in 2022–23 (such as the 2023 Models of Care for Sexuality and Gender Diverse People and People with Innate Variations of Sex Characteristics grant opportunity), this is not the only driver and there has been an overall increase in the proportion of non-binary researchers applying for and receiving MRFF funding,” the report stated.

MRFF report

Asia-Pacific Roundup: Japan’s PMDA seeks to curb medical accidents

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