Vietnam

Warning letters to SuXiang Medical Instrument in China and Yahon Enterprise in Vietnam among recent warnings FDAS sent to OTC drug and supplement manufacturers, including a Florida firm, White Label Leaf, warned about selling gummies containing delta-8 THC, and other OTC skin care product firms.

Rising Leader Jing Lim is part of the team getting 3D implant and bone regenerating innovator Osteopore better known outside its founding base in Singapore. The company stands on the cusp of accelerated growth on the back of an expanding portfolio and its best practice approach to business building.

Vietnam’s medtech industry breathed more easily when the new decree, 98/2021, became the regulatory instrument for the sector on 1 January. While its practical approach to industry’s needs was welcomed, new price and profit declaration demands will be harder for companies to swallow.

Novartis has expanded its efforts to help low- and lower-middle-income countries “mitigate the impact of the pandemic and support healthcare systems,” after signing a memorandum of understanding with Vietnam’s Ministry of Health providing various treatments for COVID-19 at-cost.

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.

Vietnam’s pharma market has seen constant growth over the last decade, driven by rising incomes and an aging population. Spending on drugs is expected to rise by more than 10% in 2021.

Survey of more than 5,000 Asia-Pacific consumers finds 56% use technology tools such as nutrition apps to support healthy living, suggesting opportunity to connect with consumers.

RAAS Nutritionals tells FDA “it proceeded without an IND because it believed that if it was legally able to sell its nutritional supplements ... it should be able to test and observe the effects of those supplements without an IND.”

Stada Arzneimittel is expanding its presence in Vietnam's $2.4bn OTC market and launching Austria's first non-prescription triptan.

Vietnam has adopted the ASEAN Common Submission Dossier Template and updated its medtech regulation to allow more compliance time for medtech manufacturers. But the IVD industry fears too much pharma influence in file auditing.

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.

Bayer Consumer Health is stepping up investments in India, China and South East Asia to unleash untapped potential in these high growth OTC markets. 

Vitamin Shoppe’s license with Kim Lien opens two stores in Hanoi and plans to launch wholesale distribution of its proprietary brands. The Asian market in recent years has been plagued by fake supplements and unknown ingredient sources, Kim Lien says.

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.

Vietnamese firm Imexpharm has received $8m in financing from the Asian Development Bank to help sustain local production considering the novel coronavirus pandemic.

Innovation has come of age in Asia, throwing up investment opportunities in China, Singapore and other Southeast Asian countries that Novo Holdings plans to tap, says CEO Kasim Kutay. The firm's Asia head, Amit Kakar, also outlines therapeutic areas of interest for the company, which is managing $65bn worth of assets.

After a 12-month period that has seen Stada make significant investments in generics, biosimilars and consumer healthcare, CEO Peter Goldschmidt tells Generics Bulletin that the firm does not intend to stop there, as it pursues both organic and inorganic growth opportunities.

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.