The enactment of Thailand’s Narcotics Code, effective December 10, 2021, marked a key milestone in promoting the commercial applications of cannabis (both marijuana and hemp) and kratom as economic plants—with subsequent regulatory developments continuing this push. For many decades, cannabis and kratom were classified as category 5 narcotics under the Narcotics Act. However, a movement for the legalization of cannabis and kratom developed over time. First, the legalization of marijuana (Cannabis indica) for medical purposes became effective on February 19, 2019, as prescribed in Amendment No. 7 of the Narcotics Act. Kratom has also been effectively decriminalized (covering consumption, production, disposal, and possession for any purpose) since August 24, 2021, as prescribed in Amendment No. 8 of the Narcotics Act. The laws governing narcotic and psychotropic substances in Thailand have now taken a significant step forward with the passage of the Narcotics Code, which is intended to be a comprehensive law covering all narcotics and psychotropic substances in Thailand. Most recently, the Ministry of Public Health announced in the Government Gazette on February 2, 2022, that only cannabis extract (both marijuana and hemp) with THC of more than 0.2% by weight will be classified as a category 5 narcotic. This means that seeds, cannabis plants, and inflorescences, if harvested in Thailand, have been removed from the list of category 5 narcotics. Although the changes to Thailand’s narcotics regulations for cannabis and kratom are intricate, both cannabis and kratom have become a topical issue for farmers and related industries. The plants are new cash crops and have attracted widespread public interest. Currently, we can see fresh kratom leaves and fresh cannabis leaves sold in the market. Unlike products with cannabis derivatives, kratom-based products are not yet available in the Thai market. Although there is an opportunity for developing kratom-based products

Indonesia’s National Agency of Drug and Food Control (BPOM) has issued a regulation to amend the country’s food labeling regulations by instituting various additional restrictions and providing additional clarity on food labeling requirements—not only for final food products but also for food additives and food products for further processing. The additions are contained in Regulation No. 20 of 2021 (an amendment to Regulation No. 31 of 2018), which took effect on August 2, 2021. The deadline to comply with the new labeling requirements for final food products is December 31, 2021, and the deadline for requirements related to food additives and food products for further processing is August 2, 2022. The new requirements introduced by the latest regulation are outlined below. Final Food Products Non-halal foods. The new regulation clarifies that food products containing non-halal ingredients are exempt from halal certification requirements. This provision is important as it explicitly confirms that non-halal food products can still be sold and distributed in Indonesia. Ingredient percentages. Percentages of ingredient content must be included in the list of ingredients on a food label, and on any ingredients that are emphasized on the label in words or pictures, or stated as part of the food name. Polyol warning. Labels for food products containing polyol must now include a warning to this effect. Allergen information. The new regulation provides an alternative for indicating allergen information on the food label. Under the 2018 regulation, allergens had to be indicated in the ingredients list in bold type, and the label had to have the disclaimer “contains allergens, see list of ingredients printed in bold.” The new regulation, however, allows allergen information to be declared on the label with the phrase “contains allergens:” followed by the allergen name(s) printed in bold. With this new alternative, it is

On November 25, 2021, the Myanmar Investment Commission (MIC) issued a list of investment sectors that will receive priority attention in order to encourage national development and state building. The investment activities that MIC will prioritize are the following: Fertilizer manufacturing Cement manufacturing Iron and steel manufacturing Agriculture and livestock farming and related industries Value-added manufacturing of foodstuffs Electric vehicle manufacturing Pharmaceutical and medical device manufacturing Public transportation services Both foreign investors and local investors may invest in these sectors, and the MIC, ministries, and relevant state and regional governments will provide necessary assistance to the investors under the Myanmar Investment Law 2016. For more details on the new requirements, please contact Tilleke & Gibbins at [email protected] or +95 9 772 440 001.

On November 8, 2021, the Vietnamese government issued Decree No. 98/2021/ND-CP on the Management of Medical Devices (“Decree 98”). The new decree will take effect from January 1, 2022, replacing Decree No. 36/2016/ND-CP and its amendments on the same subject (“Decree 36”). Below are the main highlights of Decree 98: 1. Classification of Medical Devices Under Decree 98, responsibility for the classification of medical devices is given to the organization registering or declaring the medical device. Under Decree 36, this responsibility was reserved for Vietnamese organizations qualified for medical device classification. 2. Clinical Trials of Medical Devices Decree 98 provides stricter and more detailed requirements on clinical trials. Particularly, medical device trials will include three phases, in which phases 1 and 2 need to be finished before the product registration, while phase 3 will be conducted after the medical devices are approved for circulation, following the specific requirement from the authorities. This requirement aims to continue evaluating the safety and efficacy of medical devices after they are widely used in the community in line with their usage conditions. 3. Medical Device Registration Similar to the current regulations, Decree 98 requires that medical devices must be registered with the Vietnamese authority (i.e., must obtain registration numbers) before being imported/manufactured for circulation in the Vietnam market. However, Decree 98 further stipulates new requirements as below. Validity of registration numbers Under Decree 98, the registration numbers for all classes of medical devices, not only Class A medical devices as in the current regulations, are valid indefinitely, except for registration numbers granted under the emergency registration procedure. Registration procedure for Class A/B medical devices Instead of having to register with the central level authority with a complex registration dossier as currently required, Decree 98 allows Class B medical devices to be subject to