Search for:

Product Regulation & Liability


As of 1 August 2023, the National Institute of Pharmacy and Nutrition will be merged into the National Public Health Center. The resulting new authority will be called the National Public Health and Pharmaceutical Center (NNGYK).
The new authority will be headed by the Chief Medical Officer, and in terms of administrative hierarchy, the NNGYK will be under the supervision of the Minister of the Interior, acting in the capacity of Minister responsible for Health.

Development and commercialization of innovative products/services — including smart technologies — have recently been accelerating rapidly in the healthcare industry. One example is the growing use of AI/machine learning technologies in medical devices that perform diagnosis and/or testing. Further, many software applications and wearable devices are being launched that enable ordinary consumers to collect health-related data, etc.

On 17 July 2023, the Health Sciences Authority (HSA) proposed the new regulation for active ingredients under the Health Products Act.
Against the increasing complexity in the manufacturing and supply chain of active ingredients, streamlined and risk-based regulatory controls will ensure that active ingredients consistently meet appropriate quality standards. The HSA has therefore seen the need to consolidate and enhance regulatory controls for active ingredients under the Health Products Act.

On 27 July 2023, the Ministry of Health announced the rebranding of Singapore’s health tech agency, formerly known as the Integrated Health Information Systems to Synapxe.
The Ministry of Health also outlined five key priorities of Synapxe, namely: (i) national repository for patients’ medical records; (ii) system for remote healthcare; (iii) national billing system; (iv) strong cyber and data security; and (v) looking into the future and exploring possibilities, such as generative artificial intelligence.

On 20 June 2023, the National Assembly (NA) passed the Law on Protection of Consumers’’ Rights (amended), with an effective date of 1 July 2024, superseding the current Law on the Protection of Consumers’’ Rights No. 59/2010/QH12.

The New LPCR includes seven Chapters and 80 articles under which many proposed critical changes have been officially adopted. This law also addresses various issues that will have direct impacts on onshore and offshore organizations that transact or do business with consumers in Vietnam.

In the Official Journal of 13 June 2023, the Decree of the Ministry of Health dated 12 April 2023 governing the national administrative procedures for the submission of clinical investigation applications for devices that are not CE-marked and CE-marked but used outside their intended use and the Decree of the Ministry of Health dated 12 April 2023 governing the national administrative procedures for the submission of clinical investigation applications for CE-marked devices used within their intended use were published. These decrees are provided for in article 16, paragraphs 2 and 3 of Legislative Decree No. 137/2022 issued to bring national legislation in compliance with the provisions of Regulation (EU) 2017/745.

On 27 June 2023, the Italian Medicines Agency (AIFA) announced the release of new features for the e-Dossier Price and Reimbursement web portal. The portal, available at the AIFA Services Portal, enables the preparation of dossiers in digital format to support reimbursement and price claims.

On 22 June 2023, the Court of Justice of the European Union ruled in the Joined Cases C-6/21 P and C-16/21 P on the impartiality requirement of the scientific committees’ members and experts involved in the European Medicines Agency’s activities.

On 23 June 2023, EMA’s GCP Inspectors Working Group updated the Q&A on Good Clinical Practices. In particular, the update has allowed for the possibility, if in compliance with applicable European regulations and the requirements of ICH E6 guideline, that the sponsor may support the investigator by identifying or contracting service providers or personnel to be directly involved in the conduct of the clinical trial (e.g., by providing additional resources to the clinical trial site or qualified personnel).