In the past few years China has introduced significant regulatory changes in an effort to modernize its pharmaceutical industry and bring it in line with international standards. These include reorganizing the former State Drug Administration into the State Food and Drug Administration (SFDA), thoroughly amending drug regulation and good manufacturing practice (GMP), enhancing intellectual property protection and changing drug import licensing ...
The promotion of research, development and innovation (R&D&I) has been identified as a key obligation by both the European Union as well as it member states in recent years ...
In our November 2006 Asia IP Bulletin, we reported on a ground-breaking agreement (the "Agreement") signed by the Hong Kong and Mainland Chinese Governments, under which they agreed to recognise and enforce judgments made in each others courts. The Agreement followed four years of discussion and legislative changes are now underway in Hong Kong to implement the Agreement ...
The purposes of this Health Care Alert are to: 1) summarize recently proposed federal regulations which will require physician disclosure of ownership interests in hospitals to patients; 2) remind health care providers of existing Texas laws requiring disclosure of ownership interests and 3) suggest best practices for disclosure of ownership interests ...
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 ...
Each time we give up a bit of information about ourselves to the Government, we give up some of our freedom. For the more the Government or any institution knows about us, the more power it has over us. When the Government knows all of our secrets we stand naked before official power.” [Introductory remarks of Senator Sam Ervin on S3418, Legislative History of the Privacy Act of 1974 ...
In December last year, the House of Lords handed down its judgment in the case of R (on the application of Laporte) v Chief Constable of Gloucestershire. The case considered the proper balance to be struck between an individual's Article 10 and 11 rights to freedom of expression and freedom of assembly and association under the European Convention on Human Rights ('ECHR'), and the Police's powers to prevent breaches of the peace ...
This month the Legislative and Regulatory Reform Act 2006 ('the Act') comes into force. It is one of the Government's key legislative proposals for 2006, designed to promote productivity and ease the burden of regulation. The Act replaces the Regulatory Reform Act 2001 and is part of the UK Government's Better Regulation Action Plan 2005 ...
On October 31, 2006, the Court of Appeal rendered two key decisions on the issue of neighbourhood annoyances in Quebec. It is greatly to their credit that these two judgments represent a return to more reasonable legal bases on this issue. The decisions are Ciment du Saint-Laurent inc. / St. Lawrence Cement Inc. v. Barrette and Cochrane(2) (hereinafter “St. Lawrence Cement”) and Comité d’environnement de Ville-Émard (C.E.V.E.) and Michaud v ...
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 ...
Amendment (6) to the Criminal Law of the People's Republic of China was adopted at the 22nd Session of the Standing Committee of the 10th National People's Congress of the People's Republic of China on 19 June 2006 and promulgated by President Hu Jintao on 29 June 2006. The Amendment, which entered into effect on the date it was promulgated, introduces penalties for a range of economic crimes ...
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 ...
