UPDATE: Major new regulations for complementary medicines are now in effect across the Asia-Pacific region, with significant changes rolling out in Australia, China, Indonesia, Japan, South Korea, and Vietnam. These updates are crucial for consumers and manufacturers alike, impacting the labeling and registration of health supplements and medications.
In Australia, starting May 1, 2023, all complementary medicines containing vitamin B12 in the form of mecobalamin must exclusively bear the name ‘mecobalamin’ on their labels. This change is part of the Therapeutic Goods Administration’s (TGA) efforts to standardize ingredient names through the International Harmonisation of Ingredient Names (IHIN) project. By April 30, 2026, all products must comply with this new labeling requirement. Current data shows that over 411 products have already transitioned to the new labeling.
Additionally, the TGA has initiated a public consultation on proposed changes to the labeling of complementary medicines, which will replace Therapeutic Goods Order No. 92 (TGO 92) by October 1, 2023. This includes updates to warning labels for ingredients like marine molluscs and sulfites, aimed at enhancing consumer safety.
In China, as of June 1, 2023, overseas health supplement manufacturers will be able to register their facilities directly with the General Administration of Customs of China (GACC). This is a significant shift from the previous regulations, which required a more cumbersome government recommendation process. The new Decree No. 280 simplifies entry for foreign products, which could greatly benefit consumers by increasing market variety.
Indonesia is also making waves, mandating that all health supplement products must be halal-certified by October 17, 2023. This requirement will apply to both local and foreign manufacturers, as part of a broader initiative to ensure that all products sold in the country meet halal standards. The certification process has been accelerated through online submission capabilities, although concerns remain about sourcing halal raw materials.
In Japan, from September 1, 2023, all Foods with Function Claims (FFC) must comply with new Good Manufacturing Practices (GMP) and labeling requirements. This includes clear labeling of product notifications and potential ingredient interactions, ensuring consumers are well-informed about what they are consuming.
Over in South Korea, stricter labeling regulations for products containing high caffeine and sugar alcohols will take effect on January 1, 2024. Labels must now include warnings for high caffeine content and potential digestive issues from sugar alcohols, addressing health concerns among consumers.
Finally, Vietnam is proposing new regulations requiring health supplement manufacturers to adhere to GMP or Hazard Analysis and Critical Control Points (HACCP) standards from September 1, 2023. This comes in response to previous scandals involving counterfeit health products, aiming to ensure consumer safety and product integrity.
These sweeping changes across the Asia-Pacific region illustrate a significant shift towards enhanced consumer protection and safety in the nutraceutical industry. Manufacturers must act swiftly to comply with these new regulations, while consumers can expect clearer, more reliable information about the health products they choose.
Stay tuned for ongoing updates as these regulations unfold and reshape the health supplement landscape in APAC.
