Thailand

Lotus will look forward to adding ophthalmic and respiratory products to its growing portfolio after striking a deal to swallow up Teva’s operations in Thailand.

The 25th IMDRF meeting in March 2024 agreed that regulatory reliance models save resources, encourage innovation, bring devices to the market faster and boost patient access. Singapore and Thailand have operated a model of mutual regulatory reliance for three years. Thailand also recently broached deeper collaboration with Brazil’s Anvisa.

Adult immunization programs can save “billions” for society, but their value is underestimated because of challenges around measuring broader value evidence and a lack of incentives for companies to collect this data, says the Office of Health Economics.

Eisai’s initiatives in Thailand mark the company's first attempts to collaborate directly with government organizations to address dementia-related issues. The major Japanese firm teamed up with the country’s largest private insurance firm in 2022 to extend coverage to Alzheimer's and is planning to file locally for Leqembi’s approval by March 2024.

One of firms targeted in eight most recent warnings published since early September to OTC drug manufacturers, Zhao Qing Longda Biotechnology Co. in China, was dinged for both failing to respond to a request for records and for concerns about its production with DEG and EG.

Mannatech launches in Thailand; China facility becoming Clariant’s global health care support hub; Signs in Dollar General stores link to CHPA online pain relief product quiz; and Nutrawise counsel elected CRN board chair.

As it looks to roll out its new dengue vaccine globally, Takeda will work with Kao’s Thai subsidiary on education and prevention activities in Bangkok, later expanding these to wider areas of Thailand, in the first such local collaboration by the private sector. 

Response to sale of Unilever’s direct selling business in Thailand, Unilever Life, like its recent failed bid for GSK consumer and its elimination of 1,500 management staff, exposes disconnect between its priorities and its shareholders preferences.

The US FDA says it’s “investigating certain imported medical gloves that appear to have been reprocessed, cleaned, or recycled and sold as new.” The 270 firms in question are listed on an import alert that says their gloves are subject to Detention without Physical Examination.

Here’s the complete list of foreign firms that were included on an import alert because gloves they made or sold may have been “reprocessed, cleaned, or recycled and sold as new,” the US FDA says.

The latest Asian Regulatory Discussions heard about Malaysia’s five-year device certificate renewal concerns, Vietnam industry’s suggestion for device fast-task approval routes, and the Philippines industry’s transition needs as the country’s new AMDD-based regulatory system gets up and running. Also: device news from Singapore and Thailand.

Singapore drives much of the medtech regulatory and policy thought leadership in the ASEAN region, as shown in its regulatory collaboration with Thailand and actions on cybersecurity and packaging waste.

Lotus Pharmaceuticals aims to build a stronghold in Thailand and beyond, after the Alvogen subsidiary announced a partnership with a subsidiary of Thai state-owned conglomerate PTT, which includes a $50m capital injection.

More parts of the Thai FDA’s new medtech regulations will come into force in mid-March, following the first tranche last month. Other changes will become effective later in 2021 and certain elements of the system remain a work in progress.

Medtech industry representatives from ASEANMed member economies, notably Singapore, Malaysia and Indonesia, provided regulatory updates at the February Asia Regulatory Roundtable. These roundtables are organized by the ARQon consultancy and the Asia Regulatory Professional Association (ARPA). They are sponsored by Medtech Insight.

Medtech industry representatives from Thailand, Myanmar, Indonesia, Singapore and the Philippines gave updates on regulatory actions being taken to control COVID-19 and other regulatory initiatives at local and ASEANMed level during a roundtable session.

A lack of regulatory harmonization for dietary supplements in Asia is a big challenge facing companies operating in the region, according to experts from the Asia Regulatory Professionals Association. The ARPA is looking to start a conversation on the issue which the association hopes will lead to regulatory change.

The Asian Medtech Associations Regulatory Networking discussions this month centered on strategies to control COVID-19 locally and the activities of the ASEANMed industry association. This editorial feature is hosted by Medtech Insight, along with the ARQon Asia Regulatory and Quality Consultancy and the Asia Regulatory Professional Association. This is the second of two articles on the discussions.

The Asian Medtech Associations Regulatory Networking discussions this month centered on strategies to control COVID-19 in Thailand, Singapore, South Korea, Indonesia and Vietnam. This editorial feature is hosted by Medtech Insight, along with the Asia Regulatory and Quality Consultancy and the Asia Regulatory Professional Association. This is the first of two articles from the discussions.

Keen to make strides for its growing Small Molecules business, Biocon has signed an agreement with DKSH to bring seven generic formulations to markets in South East Asia.