The deadline for renewing the drug product registration license is approaching. All renewals must be submitted by 12 October 2024
On 21 August 2024, the Italian Medicine Agency issued the Guidelines on the matter of Regulatory Simplification and Decentralization for the Purpose of Conducting Clinical Trials of Medicinal Products in Accordance with Regulation (EU) No. 536/2014.
With determination No. 425 of 8 August 2024, the Italian Medicine Agency approved the new Guidelines for the Classification and Conduct of Observational Studies, implementing the provisions of Article 6(3) of the Ministerial Decree dated 30 November 2021.
The Medical Devices Cluster of the Health Sciences Authority has released a draft guidance on the Change Management Program for Software as a Medical Device. Change Management Program is the new optional regulatory pathway that aims to streamline the SaMD regulatory framework and facilitate timely implementation of software changes for registered SaMDs in Singapore.
The Ministry of Health commenced an investigation into a clinic offering telemedicine services for its allegedly clinically and ethically inappropriate practices. The Ministry of Health has stated that this is a likely breach of the Healthcare Services Act 2020. The medical practitioners engaged by the clinic are also being investigated for breach of the Singapore Medical Council’s Ethical Code and Ethical Guidelines.
The Guidelines on the Provision of Consumer Protection Safeguards by Digital Payment Token Service Providers was first issued by the Monetary Authority of Singapore on 2 April 2024 and was recently revised on 19 September 2024 to include further consumer protection measures that were discussed in the MAS’ Response to Public Consultation on Proposed Regulatory Measures for Digital Payment Token Services (Part 2).
On 18 September 2024, the Ministry of Economy, together with the Ministry of Energy published in the Federal Official Gazette the Directive that amends and establishes the products subject to regulation by SENER regarding their import and export.
The new Tobacco Products Law and the revised Tobacco Products Ordinance entered into force on 1 October 2024. The new legislation introduces important amendments to the current law. In particular, these relate to the regulation of electronic cigarettes, tobacco products for heating and tobacco products for oral use. Moreover, further measures for the protection of children and young adults have been introduced.
Baker McKenzie’s Global Financial Services Regulatory Guide has been fully revised for 2024 and covers 35+ jurisdictions worldwide, making it our most expansive edition to date. The Guide acts as a quick reference tool when distributing financial products and offering services into new markets, providing a comprehensive summary of regulations applicable to banks and other financial services companies around the world. This expanded edition includes the rapidly growing area of cryptoassets, AML and CFT supervisors, and the extension of regulation to critical third-party outsourcers. Given the pace of regulatory change in this domain, staying informed is critical for market participants. Baker McKenzie is exceptionally well-positioned to simplify the complexity and provide expert guidance.
The Primer on Fintech in the Philippines covers legal and regulatory issues and considerations related to the financial technology sector in the Philippines, including data privacy and cybersecurity considerations, anti-money laundering compliance, and the business challenges that the sector may face.