トップ > 法律コーナー
【中国】CFDA: Regulatory Developments on Drug Registration in China
The China Food and Drug Administration (“CFDA”) has been busy publishing draft orders in the first half of 2017. Some of the draft orders and decisions are extremely important and will have far-reaching impact on the drug registration system in China. The draft orders and decisions, if passed, will speed up the entire drug registration procedure in China, benefiting foreign drug manufacturers.
【ジャカルタ】The Government Issues New Regulation on Payment and Delivery of Goods in Export Import Activities
On 21 July 2017, the Government of the Republic Indonesia issued Regulation No. 29 of 2017 on Procedure of Payment and Delivery of Goods in respect of Export and Import Activities ("Regulation 29") which came into effect on 24 July 2017.
【シンガポール】Ministry of Health Provides Additional Funding to Develop Traditional Chinese Medicine
On 2 August 2017, the Ministry of Health ("MOH") announced that it will provide additional funding of S$5 million for the Traditional Chinese Medicine Research Grant ("TCMRG") to develop and support the Traditional Chinese Medicine ("TCM") sector. This additional S$5 million funding bolsters the $3 million which had earlier been put aside for the TCM sector in December 2012 for the same purpose.
マレーシア内国歳入庁（IRB）は、段階的に2012年マレーシア移転価格ガイドライン（2012年TPガイドライン）の各章を変更し、2012年TPガイドラインを改訂することを発表しました。今回の改訂の主要目的は、マレーシアの移転価格規則を世界的な進展と足並みをそろえることですが、独立企業原則（Arm's length principle）の実施を強化し、IRBによる独立企業原則の解釈を明確にすることも目的としています。
【ベトナム】Civil Code Amendments in Practice: Representative Offices, Business Associations, etc., Lose Capacity to Operate Bank Accounts
Non-legal entities no longer have legal capacity for purposes of civil transactions
Law No. 91/2015/QH13 on the Civil Code was adopted by the National Assembly on November 24, 2015, and entered into force January 01, 2017 ("Civil Code 2015"). The Civil Code 2015 only provides for the legal capacity of legal entities (judicial persons) and individuals (natural persons) in civil transactions. Accordingly, Civil Code 2015 omits the legal capacity of non-legal entities to conduct any civil transaction.
Among other things, this means many thousands of non-legal entities, including representative offices, business associations, branches of offshore enterprises, offices of foreign contractors and NGO offices, may no longer be able to engage in any civil transaction as a party to such transactions.
【ジャカルタ・シンガポール】ESDM Regulation 42 and oil and gas companies: where have the contract rights gone, and other questions
On 14th July the Minister of Energy and Mineral Resources (Minister) published regulation no. 42 of 2017 (Reg. 42).
The share transfer / change in control and change of director provisions of Reg. 42 apply to upstream and downstream oil and gas companies, IUPTL holders (power producers) and IPB holders (geothermal companies). This alert discusses the implication of Reg. 42 on oil and gas companies.
【香港】Hong Kong Introduces Tax Exemption to Onshore Privately Offered Open-ended Fund Companies
The Hong Kong Government has proposed legislation (the Inland Revenue (Amendment) (No. 4) Bill 2017) (the "Bill") to offer profits tax exemption to onshore privately offered Open-ended Fund Companies ("Subject OFCs").1
【シンガポール】S$2.4 billion worth of government tenders to be called; recent data privacy enforcement decisions
The Government Technology Agency (“GovTech”) recently announced that S$2.4 billion worth of information and communications technology (“ICT”) tenders will be called in fiscal year 2017. Around S$528 million has been set aside for cybersecurity, a large part of which will be spent on a new Government Security Operations Centre (“SOC”). In all, spending on analytics projects and cyber security will account for more than S$1 billion. The proposed investment will also support the Smart Nation Sensor Platform ("SNSP"), which aims to facilitate the sharing of resources and data amongst agencies to contribute to more efficient urban and operational planning as well as improve the running of city services.
【ジャカルタ】Customs office now requires work permit for all foreign directors for NIK applications
Under a regulation issued by the Director General of Customs and Excise ("DGCE") which became effective on 1 March 2017 (New Regulation as defined below), all importers and exporters operating in Indonesia that intend to apply for, amend or renew their Customs Registration Number/ Nomor Identitas Kepabeanan ("NIK") now need to:
1. ensure that their foreign directors have work permits ("IMTA"); and
2. provide a copy of the IMTA to DGCE with the NIK application.
【香港】Hong Kong Significantly Expands Its AEOI Network and Proposes Joining the Multilateral Convention
On 7 June 2017, the Hong Kong Legislative Council passed the Inland Revenue (Amendment) (No. 3) Bill 2017 which expands the list of Hong Kong's reportable jurisdictions for Automatic Exchange of Information ("AEOI") purposes from two to 75. This massive expansion will come into effect on 1 July 2017. Starting on 1 July 2017, Hong Kong financial institutions ("HK FIs") will be required to identify, collect and report information of financial accounts held by tax residents of these 75 jurisdictions.
【シンガポール】 MAS Proposes Regulations for Provision of Digital Advisory Services
Recognising the growth of digital advisory services (also known as robo-advisory services) and its differences from conventional financial advisory services, on 7 June 2017, the Monetary Authority of Singapore ("MAS") issued a Consultation Paper on the Provision of Digital Advisory Services. In the Consultation Paper, the MAS sets out the licensing and regulatory framework applicable to digital advisers, proposes further legislative amendments to facilitate the provision of digital advisory services in Singapore, and sets out its expectations on how the unique characteristics and risks of digital advisory services should be addressed.
【シンガポール】Singapore Adopts ISO Standard on Anti-Bribery Management Systems
Singapore launched the Singapore Standard (SS) ISO 37001 on Anti-bribery management systems on 12 April 2017, following a public consultation from February to March 2016 on the adoption of the International Organisation for Standardization (ISO)'s new set of voluntary standards (designated as ISO 37001) for anti-bribery compliance.
【中国】China Releases Draft Rules to Implement Local Data Residency Requirement and Security Assessment Requirement on Outbound Data Transmission
China's new Cybersecurity Law, to be effective on 1 June 2017 (the "CSL"),introduced a controversial local data residency requirement, which has raised questions and concerns among multinational companies operating in China.
【中国】Market Misconduct Tribunal Continues Tough Sanctions Against Listed Companies and Their Officers for Breaches of Disclosure Requirements
On 5 April 2017, the Market Misconduct Tribunal ("MMT") fined Mayer Holdings Limited ("Mayer") and nine of Mayer's current and former senior executives a total of HKD 10.2 million for their breaches of the disclosure obligations under the Securities and Futures Ordinance ("SFO") and disqualified them from being directors or being involved in the management of a listed corporation for up to 20 months. The relevant breaches included failure to disclose certain audit issues affecting Mayer and a delay of over three weeks in disclosing the auditors' resignation.
【香港】Hong Kong Regulators Provide Further Guidance on Compliance with Suitability Obligations
The Securities and Futures Commission ("SFC") and the Hong Kong Monetary Authority ("HKMA") have issued further guidance on their expectations of the conduct requirements of financial intermediaries when selling investment products.
【香港】Hong Kong Government Signs New Automatic Exchange of Information Agreements with South Africa and Portugal and Proposes Significant Further Expansion
The Hong Kong Government has recently signed agreements for the implementation of automatic exchange of financial account information (“AEOI”) with two more countries, bringing its number of AEOI partners to nine. In addition, the Hong Kong Government has recently introduced draft legislation that adds 72 jurisdictions (including Mainland China) to Hong Kong’s list of “reportable jurisdictions”. The draft legislation proposes that Hong Kong financial institutions (“HK FIs”) will be required to report to the Inland Revenue Department (“IRD”) by May 2018 the information collected from 1 July 2017 to 31 December 2017 in respect of accounts held by tax residents of these 72 jurisdictions. Reporting in subsequent years will cover the full calendar year. This information will be kept by the IRD and exchanged with the relevant jurisdiction after an AEOI agreement has been concluded with that jurisdiction. Therefore, when an AEOI agreement is entered into with one of the prospective AEOI partners, the relevant AEOI partner will receive information from the IRD dating back to 1 July 2017.
【香港】Proposed Concessionary Tax Regime for Aircraft Leasing in Hong Kong
The Government introduced in March this year tax concessions for the aircraft leasing industry to foster the proposed development of Hong Kong as an aircraft leasing centre.
At present, the current tax rules in Hong Kong are a major impediment to attracting aircraft lessors to set up in Hong Kong. Aircraft owners in Hong Kong are taxed on rental income for offshore leasing activities whilst deductions for aircraft depreciation are denied. The tax treaty network of Hong Kong is also relatively limited.
【中国】China Completes the Revamping of Its Transfer Pricing Regime
On 17 March 2017, the State Administration of Taxation (SAT) issued the Bulletin on the Administrative Measures for Special Tax Investigation and Adjustments and Mutual Agreement Procedures1 ("Bulletin 6"). Bulletin 6 is the third and final bulletin in a series through which the SAT has comprehensively revised the transfer pricing regime under the former Circular 2².
【香港】Proposed Profits Tax Exemption for Privately Offered Hong Kong Open-ended Fund Companies
The Financial Services and Treasury Bureau ("FSTB") has introduced proposals ("Proposals") to extend the profits tax exemption currently enjoyed by publicly offered funds and certain offshore funds, to onshore privately offered open-ended fund companies ("Subject OFCs").
【中国】New China Cybersecurity Guidelines for Registration of Networked Medical Devices
The China Food and Drug Administration ("CFDA") has issued guidelines aimed to implement China's new Cybersecurity Law ("CSL") in the administration of medical devices in China. This development is a clear signal that Chinese regulators intend to enhance cybersecurity protection in the healthcare sector.