On Capitol Hill, U.S. lawmakers are considering legislation that would authorize the U.S. Food and Drug Administration (FDA) to approve generic versions of biological products. Representative Henry Waxman (D, CA), of “Hatch-Waxman” fame, has introduced the “Access to Life Saving Medicine Act” (H.R. 1038) to advance this change to U.S. law. In introducing the legislation, Rep ...
The President of the United States of America, George W. Bush, announced today the Implementation of the Dominican Republic-Central America-United States Free Trade Agreement, DR-CAFTA, with respect to the Dominican Republic. See press release from The White House http://www.whitehouse.gov/news/releases/2007/03/20070301.html#).The implementation of this free trade treaty opens a new era of commercial opportunities between the member countries to the DR-CAFTA ...
A reputation for counterfeiting, poor quality control, ever-changing and inconsistent application of regulations and the challenges of ensuring that development does not unduly prejudice the welfare of the general population - this description of China’s pharmaceutical industry is representative of much that is good, bad and challenging in China’s recent regulatory and economic development ...
In M&A transactions, the principal terms negotiated by the parties are usually the structure, price, representations, warranties and undertakings and indemnities. Whereas in most jurisdictions parties are at liberty to agree on these terms, in China the outcome of the negotiations between Chinese and foreign parties may not be as final as hoped for ...
The Ministry of Commerce (“MOFCOM”), the State-owned Assets Supervision and Administration Commission of the State Council, the State Administration of Taxation, the State Administration for Industry and Commerce, the China Securities Regulatory Commission (“CSRC”) and the State Administration of Foreign Exchange jointly issued the Regulations Regarding the Acquisition of Domestic Enterprises by Foreign Investors on 8 August 2006 ...
The Central Government of the People’s Republic of China (“Mainland”) and the Government of the Hong Kong Special Administrative Region (“Hong Kong”) jointly issued the Arrangement between the Mainland and Hong Kong for the Avoidance of Double Taxation on Income and the Prevention of Fiscal Evasion on 21 August 2006 ...
The Ministry of Commerce (“MOFCOM”) promulgated the Supplementary Regulations Regarding the Establishment of Holding Companies by Foreign Investors on 26 May 2006. The Supplementary Regulations amend and supplement the Regulations on the Investment in and Establishment of Holding Companies by Foreign Business Entities, which became effective on 17 December 2004 (the “Holding Company Regulations”) (as discussed in the 2004.4 issue of China Legal Update) ...
The Central Government of the People’s Republic of China (“Mainland”) and the Government of the Hong Kong Special Administrative Region (“Hong Kong”) reached a further understanding regarding the Closer Economic Partnership Arrangement between the Mainland and Hong Kong (“CEPA”) (as discussed in the July 2003 issue of China Legal Update) on 27 June 2006. This supplement, referred to as CEPA IV, further liberalises PRC market access for qualified Hong Kong service suppliers ...
The Government of Hong Kong and the Central Government of the People’s Republic of China (“Mainland”) signed An Arrangement on Reciprocal Enforcement of Judgments in Civil and Commercial Matters by the Courts of the Mainland and of the Hong Kong Special Administrative Region pursuant to Choice of Court Agreements between Parties Concerned on 14 July 2006 ...
The Ministry of Commerce issued the Notice on Further Improving the Work of Attracting Foreign Investment into the Logistics Sector on 20 April 2006. The Notice, which became effective on 31 March 2006, is the first major liberalisation in the PRC logistics sector since the 2002 Notice on Relevant Issues in the Work of Launching Pilot Projects for the Establishment of Logistics Enterprises with Foreign Investment (“Pilot Notice”) ...
The Ministry of Construction, Ministry of Commerce, National Development and Reform Commission, the People’s Bank of China, the State Administration for Industry and Commerce and the State Administration of Foreign Exchange jointly issued the Opinions on Regulating the Entry into and the Administration of Foreign Investment in the Real Estate Market on 11 July 2006 ...
The Ministry of Finance and the State Administration of Taxation jointly issued the Notice on Adjustment of the Scope of the Tax Refund Policies for the Purchase of Domestically Manufactured Equipment by Foreign Investment Projects on 10 May 2006. The Notice revises the value-added tax (“VAT”) refund policy for the purchase of domestically manufactured equipment (“domestic equipment”), which is available to certain foreign investment projects ...
The State Administration of Foreign Exchange ("SAFE") issued the Notice on Adjusting the Policies on Foreign Exchange Control for Current Account Items on 14 April 2006. The Notice, which became effective on 1 May 2006, further relaxes foreign exchange control over current account items ...
The Ministry of Finance and State Intellectual Property Office jointly issued the Notice of on Several Issues Concerning Strengthening the Administration on Asset Valuation in Connection with Intellectual Property Rights on 19 April 2006. Mandatory valuation The Notice clarifies the circumstances in which an assets valuation of intellectual property rights (“IP rights”) is to be conducted ...
On May 19, 2006, Act No. 214/2006, Coll. was announced in the Collection of Laws, which amends Act No. 455/1991, Coll., the Trade Licensing Act, as amended, and certain other acts; this act became effective on August 1, 2006 ...
So-called black collective investmentThe legal regulation of collective investment was based on the fact the Collective Investment Act, similar to its predecessor, the Act on Investment Funds and Investment Companies, exclusively regulated the activities of investment funds and investment companies. The new amendment brings fundamental changes in this respect ...
Within the European Union the issue of taking evidence in another member state has been regulated uniformly by the Council regulation (EC) No 1206/2001 of 28 May 2001 on cooperation between the courts of the Member States in the taking of evidence in civil or commercial matters. However some general rules relating to the procedure of taking evidence abroad were developed and established long before the adoption of the regulation ...
Section 15(a)(1) of the Securities Exchange Act of 1934 (the “Exchange Act”) provides that “it shall be unlawful for any broker or dealer which is . . . a person other than a natural person . . . to make use of the mails or any means or instrumentality of interstate commerce to effect any transactions in, or to induce or attempt to induce the purchase or sale of, any security… unless such broker or dealer is registered [with the SEC] ...
Pursuant to the Act on Drugs, the Ministry of Health of the Slovak Republic has specified in annexes to this Decree details on forms to be used for prescriptions of drugs and medical aids. By this Decree, the Ministry also has set the sample forms of medical prescription, special medical prescription, medical reference, and extract from medical prescription, order and special order ...
Before 1978, China's economic policies were mainly aimed at self-reliance. As a result, the country was virtually shut off from world economic developments. In 1978, China opened its doors to foreign investment with the goal of modernising its economy and raising the living standard of its people. The country has since established the necessary legislative basis for foreign investment and has actively sought to acquire modern foreign management and technical skills ...
The federal Pipeline and Hazardous Material Safety Administration (PHMSA) has proposed new regulations for rural onshore low stress pipelines and rural onshore gathering lines. Although PHMSA has been anticipating further regulation of these types of lines for the past few years, the Agency acknowledges that the proposed rule is a direct response to legislative and media scrutiny of recent incidents that occurred in the Alaska Prudhoe Bay field ...
As the poultry farming crisis looms and countries are on the lookout for outbreaks of infection, scientists are closely following the evolution of the virus, which is moving to new sources of infection.Before a crisis is on our doorstep, businesses should prepare themselves for the consequences of a high rate of absenteeism. Without exaggerating the risks, they should adopt preventive strategies and become aware of the legal ins and outs of their actions ...
Interdisciplinary collaborations and partnering across the medical research and life sciences sectors are becoming increasingly common. Large corporations with good industry reputations and large research budgets are seeking to collaborate with smaller companies developing next-generation products. Equally, smaller companies are coming together to share complementary know-how and technologies and to work together in the global marketplace ...
