Asia-Pacific Roundup: Japan’s PMDA opens US first office, continuing global expansion

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has opened an office in Washington, DC, establishing a physical presence in the US for the first time. The opening comes months after PMDA set up its first overseas office in Thailand.

PMDA began publicly discussing plans to open a US office last year and at one point was reportedly aiming to open the site in March 2025. In July, the agency opened an office in Bangkok, Thailand, its first overseas site, to cooperate with regulatory agencies in Asia and promote its interests inside and outside Japan (RELATED: PDMA expands beyond Japan, opens office in Thailand, Regulatory Focus, 08 July 2024).

The expansion comes amid concerns about the lag between first global approvals and authorizations in Japan and changes to the country’s position on local clinical trials. PMDA framed the launch of the Washington office as a response to the fact “more and more innovative drugs are being developed by overseas start-ups,” especially in the US.

“In the office, we will promote enhancement of pharmaceutical regulatory cooperation and information exchange on regulations with administrative organizations in the US, including the US Food and Drug Administration on site,” PMDA said.

The agency said it will use the office to provide US startups with “information regarding Japanese regulations on reviews and post-marketing safety measures, as well as offer the services including early general development consultation and related services.” PMDA believes the services will support the development of innovative drugs and medical devices for use in Japan.

Akihiro Ishiguro, who began working at PMDA in 2004, will lead the US office. Ishiguro has been involved in postmarketing drug safety, new drug review, review management and regulatory science research promotion and contributed to the development of international harmonized pharmacokinetics and clinical pharmacology guidelines. Ishiguro said his experience will help strengthen cooperation with FDA.

Press Release, More

India cuts taxes on three AstraZeneca cancer drugs, orders price reduction

India’s National Pharmaceutical Pricing Authority (NPPA) has called for cuts to the prices of the cancer drugs trastuzumab, osimertinib and durvalumab. AstraZeneca sells the three drugs.

Earlier this year, the Indian Department of Revenue eliminated custom duty on the three cancer drugs. Later, the department cut the sales tax on the medicines from 12% to 5%. The actions reduced the tax burden on the three medicines.

NPPA outlined the changes to how the products are taxed in a notice directed to manufacturers of the three cancer medicines. The agency wants savings enabled by the cuts to be passed on to consumers.

“All the manufacturers and marketing companies selling the above-mentioned drugs/formulations are required to revise the [maximum retail price] of drugs/formulations on which custom duty has been made nil and [goods and services tax] has been reduced,” NPPA said. The maximum retail price includes taxes and duties. As such, when taxes go down the price should also go down.

NPPA has asked affected companies to submit information about changes to the prices of the products. The agency has also asked manufacturers to “issue a price list or supplementary price list to the dealers, state drugs controllers and the government indicating changes.”

NPPA Notice, More

Pakistan set to make e-reporting system mandatory for all safety reports

The Drug Regulatory Authority of Pakistan (DRAP) is set to require the submission of all individual case safety reports (ICSRs) via its e-reporting system from 8 November.

DRAP worked with the Uppsala Monitoring Centre to create the system. The one-way submission tool is designed to make it easier for registration holders to submit safety reports by the regulatory deadlines. DRAP, which will give each registration holder two accounts, said the e-reporting system supports E2B XML submissions and manual data entry for non-E2B pharma companies.

To date, DRAP has worked with “a selected number of registration holders” in a pilot project to evaluate the system. DRAP said the pilot project was successful. Building on that experience, the regulator is now set to make the submission of ICSRs via the e-reporting system mandatory.

Registration holders need to act to ensure they have access to the system. DRAP is asking companies to send details of the two people who will have e-reporting accounts. The agency said the account holders should “preferably” be a company’s qualified person for pharmacovigilance or local safety officer and their backup.

DRAP has provided a form for submitting the information. The agency, which published the notice on 30 October, has given companies 30 calendar days to complete and return the forms. DRAP has provided guidance on the application process in an e-reporting manual that will take effect on 8 November. The guidance also covers the process of submitting an ICSR.

DRAP Notice, E-Reporting Manual

TGA investigating reports of Guillain-Barré syndrome after Shingrix vaccination

Australia’s Therapeutic Goods Administration (TGA) is investigating a possible association between GSK’s Shingrix and Guillain-Barré syndrome (GBS).

TGA began the investigation after receiving two reports about the adverse event. The Australian reports add to the findings of an earlier observational study, which found an increased risk of GBS in people aged 65 years and over in the 42 days following vaccination. The estimated increase was three excess cases per million doses administered and the study was unable to show a causal relationship.

The Australian product information for Shingrix already referenced the observational study and possible association with GBS. TGA has updated the information in response to cases of the adverse event seen in Australia. As of 18 September, TGA’s database featured 13 reports of GBS after Shingrix vaccination. All the reports involved patients in their mid-60s to mid-80s. No deaths were reported.

“Our investigation recommended that GBS be included in the adverse event section of the Australian Shingrix PI,” TGA said. “This update harmonizes the Australian PI with corresponding information from the United States and Canada.” The product information lists GBS as a very rare adverse effect and says the available information is insufficient to determine a causal relationship with Shingrix.

TGA Notice

Other news:

TGA has reported continuing imports of counterfeit ivermectin. The agency published warnings about counterfeit versions of the drug in December 2021 and March 2022. TGA sent another alert last week after testing of a further six imported, unregistered ivermectin products found the goods to be counterfeit. The products contained less than the stated amount of ivermectin. TGA Notice

DRAP has clarified that companies need to submit the prescribing information and information leaflet of imported finished pharmaceutical products using Form 5F. Pakistan’s Registration Board stated that the requirement is mandatory at a recent meeting, leading DRAP to publish a statement. DRAP Notice

Asia-Pacific Roundup: Japan’s PMDA opens US first office, continuing global expansion

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