Earlier today, FDA announced that it has determined that the regulatory authorities of Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom are “capable of conducting inspections of [pharmaceutical] manufacturing facilities that meet FDA requirements,” and that the Agency will begin relying “on the inspectional data obtained by these eight regulatory agencies” immediately.
The simple fact is that the Chinese antitrust regulators are determined to up their enforcement activities in the life sciences industry. Almost immediately after drug pricing was liberalised in 2015, an antitrust enforcement decision was announced against a government entity, a local health commission, for breaching a number of provisions in the Anti-Monopoly Law (AML).
On 12 July 2017, the German Federal Government significantly reinforced the barriers for the acquisition of German companies by non-EU companies. The new Regulation for the Amendment of the Foreign Trade and Payments Regulation (“AWV”) will impose new reporting obligations for M&A transactions. There are now concerns about the openness of Germany to foreign investment and the additional burden that the new rules will impose on companies.
Following serious incidents of civilian drones entering the airspace of Chinese airports and causing flight delays last April, China’s civil aviation authority has issued the Real-name Registration of Civil Unmanned Aircraft Administrative Provisions, with effect from May 16, 2017, in an effort to increase accountability for drone use by requiring owners and manufacturers of civilian-use unmanned aircraft systems to complete “real-name” registration procedures.
In an effort to avoid the duplication of drug inspections, lower inspection costs, and enable regulators to devote more resources to other parts of the world where there may be greater risk, the U.S. Food and Drug Administration (FDA) and the European Union (EU) today announced that they have enhanced their agreement on mutual recognition
In 2014, the Committee on Foreign Investment in the United States, a U.S. Government interagency committee that conducts national security reviews of foreign investments, reviewed nearly 50% more transactions than it did in 2013, according to CFIUS’s recently published annual report to Congress. The dramatic increase likely reflects a combination of factors, including an increase in cross-border M&A activity, transactions involving sensitive industries or acquirers, and parties continuing to make filings with CFIUS across a broad range of industries.
On December 28, 2015, the Government of India released the text for its revised model Bilateral Investment Treaty (BIT). In this release, the Government of India also announced that the Department of Economic Affairs will be leading all negotiations on BITs and investment chapters of trade agreements to ensure continuity between trade and investment issues.
On 8 December 2015, the State Administration for Industry and Commerce (SAIC) – one of China’s three antitrust authorities – published a decision of its local office in Guangdong holding a trade association in breach of the Anti-Monopoly Law (AML). The trade association was found to have organized a “collective boycott” for its members, and
President Barack Obama recently signed legislation that imposes multiple new requirements relating to the regulation of exports of civil nuclear technology. Under the new law, the U.S. Secretary of Energy must make a number of changes to the Department of Energy’s nuclear export control regulations and approval process contained in 10 C.F.R. Part 810. The new law has had an immediate impact on the transfer of U.S. civil nuclear technology to China and Russia. Until the DOE has resolved how it will comply with these new requirements, it is unlikely the DOE will issue any specific authorizations for transfers of U.S. civil nuclear technology to China and Russia.
On 9 October 2015, the China Insurance Regulatory Commission (“CIRC“) issued draft Supervisory Rules for Adoption of Information Technology by Insurance Institutions (“Draft Insurance IT Rules“) for public comment. The public comment period will close on 31 October 2015. The Draft Insurance IT Rules have been issued to replace the 2009 (Pilot) Guidance on Administration
China’s regulatory framework for foreign investment in the e-commerce industry has undergone significant liberalization. Previous pilot programs on a local level have been extended nationwide, with directives from the highest political level to remove restrictions. On 19 June 2015, the Ministry of Industry and Information Technology issued a notice to lift foreign ownership restrictions in
On 13 April 2015, the State Administration for Industry and Commerce (SAIC) – one of the three antitrust authorities in China – published the long-awaited regulation on how China’s Anti-Monopoly Law (AML) applies to the exercise of intellectual property rights (IPRs). In this one-hour lunch seminar, our Beijing office partner Adrian Emch will address these
The recently published annual report to Congress by the Committee on Foreign Investment in the United States (CFIUS), a U.S. government interagency committee that conducts national security reviews of transactions that could result in control of a U.S. business by a foreign person, suggests that the committee’s reviews are becoming increasingly stringent. Read More: CFIUS
China’s new regulation on value-added tax (VAT), which went into effect on 1 August 2013, may increase charges on exports originating from China by up to 6 per cent. Circular No. 37 of 2013, jointly issued by China’s Ministry of Finance (MOF) and State Administration of Taxation (SAT), provides for the replacement of business tax
The National Development and Reform Commission (“NDRC“) has started 2013 with a bang. On 4 January 2013, it announced that it had imposed sanctions of close to USD 56 million on six liquid crystal display (“LCD“) makers from Korea and Taiwan, accusing the companies of illegal price-fixing. These sanctions set an absolute record for antitrust
The State Department and the US Trade Representative (USTR) unveiled last week the new US Model Bilateral Investment Treaty (BIT). The release of the 2012 Model BIT signifies the completion of an Obama Administration campaign promise to conduct a thorough review of U.S. investment policy. The 2012 Model BIT retains the core protections set forth