Indonesia

Generics Bulletin reviews the latest regulatory developments across the world.

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.