The AEMPS (Spanish Medicines and Medical Devices Agency) has published new guidelines on how conduct clinical investigations with medical devices, in order to adapt them to the EU Regulation 2017/745. The main changes include adjustments regarding the requirements for approval of clinical investigations, modifications to the procedures and deadlines and the documentation required.
The Australian Securities and Investments Commission has provided updated guidance on the updated breach reporting regime applicable to Australian Financial Services Licensees and Credit Licensees. ASIC’s updated guidance is set out in a new version of Regulatory Guide 78, ‘Breach Reporting by AFS Licensees and Credit Licensees’ (RG 78), published 27 April 2023.
On 3 May 2023, the Securities and Exchange Commission adopted new rules to modernize and enhance the disclosure requirements for repurchases of equity securities by publicly listed companies, often referred to as stock buybacks. Among other changes, the amendments will require issuers to disclose in their periodic reports their daily share repurchase activity for each quarter (replacing the proposed rule that issuers would have to make daily filings of share repurchase activity) and provide certain additional narrative disclosure about their share repurchase programs in periodic reports. The SEC also adopted new Item 408(d), which will require disclosure in issuers’ periodic reports regarding the adoption and/or termination of 10b5-1 trading arrangements during the reporting period.
The PMPS, in which commercial communications of medical devices were registered, ceased to be operational and was replaced by the new CCPS application of the AEMPS. However, communications made to the PMPS were still valid, although they cannot be managed until they are migrated to the CCPS. Consequently, the AEMPS has set the deadline of 18 July 2023 for the transfer of marketing communications to the new CCPS application, requesting companies to retrieve them by that date, updating their information and submitting them to the necessary review by the AEMPS, prior to their inclusion in CCPS.
The new Delegated Regulation (EU) 2023/647 has amended the former Delegated Regulation (EU) 2020/686, which in turn complemented Regulation (EU) 2016/429, on the prevention and control of transmissible animal diseases, animal health requirements and traceability of animal reproductive products. The new Regulation complements the rules laid down in the original regulation as regards animal health issues of traceability and certification of movements of captive breeding products of terrestrial animals. Furthermore, the main objective of the regulation is to unify the different regulations applicable on this matter in order to improve their application and to avoid duplication or cross-references.
The AEMPS has published new indications on the adaptation of veterinary medicinal products to the content of Regulation (EU) 2019/6, which establishes a period of five years for veterinary medicinal products authorized under the previous legislation to adapt to the provisions of the new Regulation. For this reason, the Quality Review of Documents has been adapted to version 9.0 on the summaries of product characteristics, package leaflet and labelling of veterinary medicinal products.
The United Arab Emirates’ federal-level financial services regulator relevant to securities, commodities and now Virtual Assets Service Providers, the UAE Securities and Commodities Authority (SCA), has just issued two new regulations relevant to Virtual Assets:
1. SCA Chairman of the Board of Directors’ Decision No. (26/RM) of 2023 in relation to Virtual Assets Platform Operators
2. SCA Chairman of the Board of Directors’ Decision No. (27/RM) of 2023 amending SCA Chairman of the Board of Directors’ Decision No. (13/RM) of 2021 in relation to the SCA Rulebook
On 2 May 2023, the Argentine Securities and Exchange Commission issued General Resolution No. 959/2023 in order to restrict the sale of marketable securities with settlement in foreign currency for parties that hold positions in surety bonds and/or repos, regardless of the settlement currency. Likewise, settlement and clearing agents are prohibited from granting financing to the transactions mentioned above. Finally, the term of permanence in portfolio for the sale of marketable securities with settlement in foreign currency in foreign jurisdiction is modified.
Most major companies have implemented a compliance program but often struggle with two issues: ensuring the compliance program remains effective in light of their existing and changing landscape and making it more efficient by leveraging technology. The Compliance Cockpit specifically addresses both issues.
In the second episode of our Digital Transformation in the Healthcare Industry series, the Healthcare and Life Sciences team at Baker McKenzie brings us up to date with the current laws and regulations relating to telemedicine and telepharmacy in Thailand and associated issues.