On September 5, 2022, the Ministry of Health of Vietnam issued Circular No. 07/2022/TT-BYT on drugs requiring bioequivalence (BE) studies and requirements for dossiers reporting BE data when registering drugs in Vietnam (Circular 07). Circular 07 will take effect on November 1, 2022, replacing Circular No. 08/2010/TT-BYT guiding the reporting of bioavailability/bioequivalence data when registering drugs. Circular 07 includes provisions on (i) generic drugs containing active pharmaceutical ingredients (APIs) or having dosage forms that require BE reporting when registering the drugs in Vietnam and (ii) dossiers for BE reporting of generic drugs. The most outstanding point under Circular 07 is that the list of APIs requiring the submission of BE reports in their drug registration dossier includes 26 APIs instead of 12 APIs as specified in the previous circular. In addition, generic drugs having the following dosage forms must have a BE report in the drug registration dossier: Drugs in immediate-release dosage form, with systemic effects, containing APIs included in the list of 26 APIs and not falling in the cases of BE reporting exemption, Drugs in modified-release dosage form, with systemic effects, that do not fall in the cases of BE reporting exemption. Roadmap for Application From November 1, 2022, the registrants of the following drugs must submit a report on BE study data along with the drug registration dossier: Generic enteric-coated drugs, in immediate-release or modified-release form, containing single APIs or fixed-dose API combinations in which the APIs are included in the list of 26 APIs mentioned above. Other generic drugs in modified-release form, except for enteric-coated drugs with APIs excluded from the list of 26 APIs. From November 1, 2025 (36 months after the effective date of Circular 07), the registrant must submit a BE data dossier along with the drug registration dossier for all generic

Thailand’s recent removal of cannabis from the list of narcotics represents a significant development for the country, and it has some human resources teams wondering whether they should prepare certain measures in order to prevent detrimental incidents from happening in their organizations. For example, some employees could still be under the influence of cannabis because they used it before coming to work. In the past, this was rarely a consideration as cannabis was clearly banned. Using cannabis or possessing cannabis inside the employer’s premises subjected employees to criminal liability including imprisonment and fines. However, now that the government has removed cannabis from the narcotics list under the Narcotics Act, such incidents are more likely to occur. This likelihood has led to concern among many employers about how they can prevent or handle these incidents. An employer does have the right to prohibit any employee from bringing cannabis inside its premises, as it is the property of the employer. The employer has the management right to do this, particularly as an employee’s use of cannabis may very well disturb other employees. But if the employer would like to set penalties for breaching the prohibition, the picture is more complicated. Employers’ Work Rules Under the Labour Protection Act (LPA), an employer who has at least 10 employees must have Thai-language work rules. These work rules must include the following items: Specification of working days, regular working hours, and rest periods; Holidays and rules for taking holidays; Rules concerning overtime work and work on holidays; Arrangements for payment of wages (i.e., schedule and location); Overtime pay, holiday pay, and holiday overtime pay; Leave and rules for taking leave; Discipline and disciplinary actions; Submission of grievances; and Termination of employment, severance pay and special severance pay. To issue or amend work rules (e.g.,

On September 5, 2022, Vietnam’s Ministry of Health (MOH) issued Circular No. 08/2022/TT-BYT on the registration of drugs and drug materials (Circular 08). Circular 08 will come into effect on October 20, 2022, and replace Circular No. 32/2018/TT-BYT and its amendments, which are the current regulations on drug registration. Below are some noteworthy contents of Circular 08: The requirements on providing a Certificate of Pharmaceutical Product (CPP) are less stringent under the new regulations. For example, a CPP is now only required to include content as stipulated in the WHO’s CPP template. No additional contents—such as specification of finished products, APIs, herbal ingredients, and names and addresses of the API/herbal ingredient’s manufactures as under the current regulations—are required. Another new point is that, for the registration dossiers of new chemical drugs, vaccines, and imported biologicals (except probiotics), applicants are required to submit only one CPP issued by the manufacturing country if the CPP issuing authority is the EMA or any SRA (Stringent Regulatory Authority); no additional CPP/legal document is required as currently. There will be a new option for providing legal documents of the manufacturer of APIs, excipients, capsule shells, semi-finished herbal medicine products, and herbal ingredients to prove compliance with GMP requirements. In particular, in addition to a GMP certificate, manufacturing license stating the manufacturer meets GMP, CPP for API with content satisfying GMP, Certification of Suitability (CEP), or self-evaluation form, it is acceptable if the company submits a Good Agricultural and Collection Practices/GACP certificate (for herbal ingredients) or other legal documents granted by the authorities containing at least the following contents: name and address of the manufacturer, certification that the manufacturer meets GMP requirements, and name of the drug substance/excipient/capsule/semi-finished medicinal material/medicinal ingredient. For vaccines, serums containing antibodies, and derivatives of human blood and plasma, Circular 08

In keeping with the government’s strong focus on consumer protection in recent years, Cambodia’s consumer protection authority issued a notice on consumer product labeling on September 23, 2022. The notice from the General Department of Consumer Protection, Competition, and Fraud Repression (CCF) provides clarifications on labeling rules for general consumer products, goods, and services. The most significant clarification is that both locally produced and imported products, goods, and services must have a Khmer-language label or attach a product description in Khmer language. Imports may use a sticker with Khmer language as long as the minimum labeling requirements are met. The notice announces a transition period for companies to amend their labeling, allowing them to make changes to the labeling until December 31, 2022. According to the notice, the CCF will investigate and take enforcement measures starting January 1, 2023. This likely signals a major increase in enforcement efforts throughout 2023. Labeling Rules The CCF notice gives instructions on product labeling rules. In Cambodia, “product” refers to general products, goods, and services on the Cambodian market. Product-specific labeling regulations (e.g., for food products) overrule the requirements for these general products. The CCF notice provides the following instructions: All products on the market must have a label, or attach a product description, using Khmer language. Imported products that do not have a Khmer-language label printed on the packaging should provide a product description in Khmer. Companies can attach the necessary information or apply a sticker to the product. Trademarks on the products may use a foreign language but must be in line with the relevant local trademark registration. Foreign-language or different labeling is only permitted if authorized by the regulator, or by regulations that apply to a specific type of product. The label or product description must use an appropriate font