Thailand’s FDA has issued a new notification, effective July 16, 2026, that changes the documentation required to renew a drug registration certificate. Renewal is no longer a routine administrative step, as applicants must now demonstrate that their quality, efficacy, and safety documentation remains current. This means information such as specifications, manufacturing compliance, stability data, and pharmacovigilance needs to be submitted for renewal. The Thai FDA may rely on ASEAN, ICH, or pharmacopeial standards, as well as decisions from recognized regulators such as the FDA, EMA, MHRA, and Japan’s PMDA. Renewal applications that were already pending when the notification took effect will be assessed under these new requirements. Thus, applicants with cases in progress may be asked to submit additional information. Foreign manufacturers, particularly those with older registrations, should coordinate promptly with their Thai local agent to ensure documentation is updated and ready for renewals.
Singapore’s Health Sciences Authority (HSA) has updated its guidance on electronic labelling (e-labelling) for therapeutic products as of June 2026. Registrants with a secure online system are now allowed to distribute HSA-approved package inserts and patient information leaflets digitally, with or without printed copies. E-labels must be presented in a machine-readable format accessible without login or personal data. Registrants are responsible for keeping the information current, updating it within 30 days of any labelling change and ensuring hosting websites carry no promotional or misleading content. Registrants may direct users to e-labels via a URL, QR code, or other machine-readable code on the product packaging, with clear instructions on how to access them. Companies must submit an online notification to HSA before actually implementing e-labelling for their registered products.