Indonesia

Generics Bulletin recaps the most recent regulatory news and updates from across the world.

Aurobindo’s acquisition of 15 brands from Pfizer and Viatris to gain entry to Indonesia marks a role reversal of sorts as Pfizer has been licensing generics from Aurobindo. Scrip takes a look at some of the opportunities and challenges in this growing Southeast Asian market.

CDER manufacturing quality director notes origin of Food, Drug and Cosmetic Act in 1938 is linked to DEG/EG poisoning. FDA says current outbreak in at least seven countries “one of the largest epidemics of DEG and EG poisoning in history.”

The first approval of a China-originated mRNA COVID-19 vaccine has come ahead of the key Communist Party Congress and Beijing's next pandemic policy decisions will be closely watched.

Takeda’s dengue vaccine Qdenga has received its global first approval in Indonesia, as Qdenga, also marking the first time for the firm to market a vaccine outside Japan and potentially paving the way to wider global use of vaccines for the mosquito-borne disease following setbacks for earlier contenders. 

Innovent and marketing partner Etana have celebrated an approval for their Bevagen bevacizumab biosimilar from the Indonesian regulator.

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.

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.

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

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.

Innovent Biologics has broadened its international reach by striking a licensing deal with PT Etana Biotechnologies in Indonesia for its Byvasda bevacizumab biosimilar.

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.

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.

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.

Part 1 of this month’s Asian Medtech Associations Regulatory Networking discussions features Asean medtech market developments and Asian Harmonization Working Party news. Part 2 was a guest presentation on the current Brexit and EU IVDR outlook. This feature is hosted by Medtech Insight, the Asia Regulatory and Quality Consultancy (ARQon) and the Asia Regulatory Professionals Association (ARPA).

This month's Asian Medtech Associations' Regulatory Networking discussions focused on amended Thai medical device regulations, more concerns over Vietnam's already-deferred, dedicated medtech legislation, and regulatory news updates from Indonesia. There was also a further take on compliance with the EU MDR, seen from an EU manufacturer's viewpoint. This Asia Networking series is hosted by Medtech Insight and sponsored by the Asia Regulatory and Quality Consultancy (ARQon), and the Asia Regulatory Professionals Association (ARPA).

The second Asian Medtech Associations Regulatory Networking discussion focused on a range of regional issues, including the latest on-the-ground news and views. Hosted by Medtech Insight, and sponsored by the Asia Regulatory and Quality Consultancy (ARQon), the Asia Regulatory Professionals Association (ARPA) and Medtronic, this session is reported in two parts, with this first part focusing on Malaysia.

The June 2 update to FDA's list of businesses and their products banned from import also increases the number of Canadian firms identified during 2017 as shipping supplement products that make drug claims or that were made in facilities out of compliance with the agency's good manufacturing practices regulations.