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 ...
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 ...
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 ...
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 ...
As concerns the contents of the Act, we can say primarily that certain proven principle and institutes reappeared known from original Act No. 199/1994, Coll., on Public Procurement which Act No. 40/2004, Coll ...
The Sappier Decision: Supreme Court of Canada Recognizes Aboriginal Right to Timber for Domestic Purposes and Clarifies Requirements for Establishing an Aboriginal RightOn December 7, 2006, the Supreme Court of Canada handed down its decision in the cases of Gray v. R and R. v. Sappier and Polchies ...
The legal systems of the nations that comprise the Gulf Cooperation Council -- Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and the United Arab Emirates -- have undergone dramatic, radical and progressive change and development in the past 25 years, which is continuing ...
On 4 December 2006 the Disability Equality Duty will come into force. It will join the broadly similar Race Equality Duty, which has existed under the race relations legislation since 2001. Meanwhile, an analogous Gender Equality Duty is due to come into force in April 2007.The intention behind the creation of these new duties is to ensure that bodies which exercise public functions “mainstream” equality issues when exercising those functions ...
Bolivia has just culminated the step that will have the greatest impact in the process of creating a new constitution for Bolivia. On Sunday July 2, Bolivia elected the constituents to the assembly that will be in charge with providing structure and substance to the new constitutional norm ...
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 ...
The revelations of the intercepted phone messages from Prince Harry and Prince William earlier this year are a reminder of how vulnerable personal data can be. Proposed changes to the law will mean that those who hold confidential personal information must be even more vigilant about what they do with that data. Most businesses will be familiar with the Data Protection legislation but it is important not to be complacent ...
There has been a great deal of interest generated by the Bankruptcy and Diligence etc (Scotland) Bill on its passage through the Scottish Parliament ...
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 ...
• Directors of NPOs are subject to substantially the same duties and liabilities as directors of for-rofit companies • Being a director of an NPO is not merely an honorary role • The corporate governance rules recommended for or imposed on reporting issuers are examples of best practices for NPOs; however, like for small businesses, they should be adapted, depending on the situation, to avoid unduly complicating the NPO’s processes • Special attention should be paid to certain differenc
State Aid is something of a European hot potato as the European Commission is currently in the process of reforming the rules surrounding State Aid. This reform process is the key priority for Robert Hankin, head of the Regional Aid Unit at the European Commission. State Aid involves support given by a member state to businesses, in the form of subsidies or tax breaks for example, and has a wide-ranging impact throughout Europe ...
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 ...
What will the impact be when the Scottish Parliament Finance Committee reports on Accountability and Governance asks Kelly Harris The Finance Committee of the Scottish Parliament has been conducting an inquiry into Accountability and Governance in Scotland, looking at the proliferation of Commissioners and Ombudsmen established since devolution. The impetus behind the inquiry was the growing concern that money might be being wasted as a result of overlapping functions and responsibilities ...
The implementing rules and regulations of Republic Act No. 6957 as amended, or the BOT Law, have been revised to increase incentives, minimize government regulations, allow reasonable returns on investments, share risks between the government and the project proponent, and assure transparency and competitiveness in the bidding and award of projects ...
