Asia-Pacific Roundup: PMDA expands beyond Japan, opens office in Thailand

The Pharmaceuticals and Medical Devices Agency (PMDA) has set up its first office outside of Japan, opening a site in Bangkok on 1 July. The agency aims to cooperate with other Asian regulatory agencies and promote its interests inside and outside Japan.

PMDA outlined plans to open an office in Southeast Asia a year ago, according to a post on RAPS Regulatory Exchange. The new office is headed by Kitahara Jun, a long-term PMDA employee who spent time overseas as an international liaison officer at the Swiss regulatory agency.

PMDA framed the expansion as part of a push to promote the harmonization of regulations in Asia and improve clinical development in the region. The agency sees those changes as ways to improve public health, pharmaceutical safety, and the region's access to drugs and medical devices.

PMDA said the decision to make Bangkok its first overseas office reflects “existing relationships with Asian countries, especially [Association of Southeast Asian Nations (ASEAN)] member states, and geographical advantages comprehensively.” The agency will leverage those relationships and advantages as it offers various services.

“The Asia office will provide the services including development of regulatory cooperation platforms with Asian regulatory authorities, direct information exchange on pharmaceutical regulation and various consultations, other related services with companies or organizations expanding in the Asian regions, and local companies or organizations,” PMDA said.

The move furthers the “grand design for Asian pharmaceutical and medical device regulatory harmonization” that Japan established in 2019 and the commitment related to international contributions and proposals that PMDA made in its fifth mid-term plan.

The Regulatory Exchange post also mentioned a potential US office for PDMA, with Washington listed as the likely location. Additionally, an article in The Japan Times said PMDA plans to open the US office by March 2025 and offer free consultations to help US startups develop drugs in Japan.

The attempt to get companies to enter the market sooner comes amid government concerns about the lag between the first global approvals and authorizations in Japan. To close the gap, the government has changed its approaches to local clinical trials and drug pricing.

Press Release

China’s NMPA agrees to deepen cooperation with the Netherlands and Indonesia

The deputy commissioner of China’s National Medical Products Administration (NMPA) has met with leaders from the Netherlands and Indonesia to discuss how the agency can work with the countries.

Both countries recently sent delegations to China. Xu Jinghe, the deputy commissioner of NMPA, met with Barbara Goezinne, director general for curative care at the Netherlands’ Ministry of Health, Welfare and Sport.

“Goezinne said the two countries face common challenges in the regulation of drugs and medical devices, noting that the Netherlands is willing to enhance communication with China at all levels to jointly improve the quality of drugs and medical devices,” NMPA said in a statement. “The two sides agreed to further deepen regulatory exchanges and collaboration to better serve public health.”

The exchange built on an earlier meeting between the Chinese president and Dutch prime minister. At the meeting, President Xi Jinping discussed China’s development of a regulatory system for drugs and medical devices, reforms of the review and approval system and steps to strengthen quality regulation throughout the lifecycle, according to the statement.

Days after meeting with Goezinne, Xu sat down with a delegation led by Rizka Andalucia, acting director of the Indonesian Food and Drug Authority (BPOM). Xu outlined changes in China, Andalucia presented details of reforms in Indonesia and both sides agreed to deepen exchanges and cooperation in drug regulation.

“The two sides had in-depth exchanges on the law-based regulation of drugs and medical devices, quality management throughout whole-life cycle of products, building of regulatory systems and capacity, promotion of global regulatory convergence, harmonization and reliance, and participation in the implementation of the development strategy of the Global Harmonization Working Party,” NMPA said in a statement.

Press Release, More

Australian diagnostic importer agrees court-enforceable restrictions on activities

2San Pty Ltd. has entered into a court-enforceable undertaking related to the unlawful import and supply of unregistered therapeutic goods in Australia.

The Therapeutic Goods Administration (TGA) said 2San imported bacterial vaginosis tests and pregnancy test kits that were not included in the Australian Register of Therapeutic Goods (ARTG). 2San supplied the medical devices to a national retailer that then sold them to the public, TGA said. Companies must enter therapeutic goods in the ARTG before they can legally be imported and supplied in Australia.

The products were registered in the ARTG, according to the agreement with the government. However, the registered products were supplied in different packaging and with different numbers of devices in a package. That led TGA to ask 2San for information and to later give the firm an opportunity to explain why it should not take regulatory action for the alleged unlawful importation and supply of devices.

2San admitted a contravention of the Therapeutic Goods Act after being contacted by TGA. The company stopped importing the products when it became aware of a possible regulatory breach and took actions, such as employing an Australia-based quality and regulatory professional, to address its non-compliance. 2San also entered into the enforceable undertaking.

The agreement requires 2San to conduct an annual audit and provide the written report to TGA, pay the costs of its compliance with the undertaking, conduct a recall, seek to obtain an ISO quality management systems certificate and notify the authorities of any suspected noncompliance within 48 hours.

Press Release, Enforceable Undertaking

NMPA invites WHO experts to China for good regulatory practice training sessions

China’s NMPA has held training sessions on good regulatory practices (GRP) and regulatory performance indicators (RPI) to promote the construction of its national vaccine regulatory system.

NMPA invited experts from the World Health Organization (WHO) to the sessions in the city of Kunming. The experts introduced the specific practices of relevant countries and regions, participated in talks with trainees on specific cases and shared information on GRP and RPI.

“Experts from the Department of Regulation and Pre-qualification of the WHO headquarters provided detailed explanations on the nine principles of the GRP and their implementation requirements, as well as the development, implementation and monitoring of the RPI,” NMPA said.

Related officials from medical products administrations at the provincial level across China participated in the training online.

NMPA Notice

Other news:

Singapore’s Health Sciences Authority (HSA) has shared notices about the risk of oxidation of Exactech Optatrek Patella implants with defective packaging and the potential for amplified noise with Medtronic LINQ II Insertable Cardiac Monitoring Systems. HSA Notice, More

Japan’s PMDA has updated the precautions on freeze-dried smallpox vaccines prepared in cell culture. The precautions discuss the use of the vaccine in people with HIV infection and the storage of the products. PMDA Update

Asia-Pacific Roundup: PMDA expands beyond Japan, opens office in Thailand

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