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 ...
Some things change, others never change. The choice of procurement route is still governed by three main factors:· Time· Cost· Quality It is hard, if not impossible to achieve the best of all these three but when choosing a procurement route consideration must be given to the list of priorities so that people's expectations are properly managed ...
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 Office of Fair Trading has written to a number of undisclosed companies in the construction industry, in relation to its ongoing investigation into a suspected multi-billion pound bid rigging cartel. It is offering the "late comers" a last chance to mitigate the potential fines which might be ascending upon them in the biggest cartel investigation in UK history ...
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 ...
When the government and a contractor negotiate a construction contract, they usually stipulate in the contract that, in case of any dispute arising from the contract, such dispute shall be submitted to the engineer or the architect for decision before such dispute is submitted for arbitration. This is what is commonly referred to as a¡§pre-arbitration¡¨ procedure ...
1 When Do We Need a Building Permit?As a rule, the construction of or any structural alterations to any building situated on theRomanian territory requires a building permit. Few are the contexts where this rule is notapplicable. These situations usually refer to the repairing and maintenance works to the existingbuildings, which do not involve changes in the initial features of the buildings ...
Pursuant to the so-called Four Years Act, owners may unilaterally increase the rent for certain apartments during the period of 2007 to 2010 for once a year up to the target value. The calculation method is set forth by law and the target value will be announced by the Ministry for Local Development in the Collection of Laws. The written announcement of the increase must be duly justified. The lessee may file an action in respect of invalidating the increase ...
During the past decade, project financing structures have been actively used in Colombia in connection with the construction and improvement of infrastructure facilities and the expansion of access to basic public services. In particular, private investment has been active in concessions, the privatization and capitalization of public entities, BOT, BOO and BOLT schemes and other financing techniques ...
On 11 July 2006, six Chinese ministries (Ministry of Construction, Ministry of Commerce, National Development and Reform Commission, The People’s Bank of China, State Administration for Industry and Commerce and State Administration of Foreign Exchange) jointly issued a circular “Opinions on Regulating the Entry into and the Administration of Foreign Investment in the Real Estate Market” Jianzhufang [2006] Circular No ...
The removal of the Crown’s immunity from English planning law will make buying and developing such land much easier, says Shoosmiths’ planning law team. Crown Immunity dated back to the 1960s and included government departments such as the MOD, Her Majesty’s private estates, the Duchies of Lancaster and Cornwall and the Crown Estate Commissioners. In the past the Crown had only to consult with local planning authorities before carrying out development ...
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 ...
For many years, parties have created various legal tools to grant others the right to use a portion of their lands. Prior to the imposition of statutory controls on the subdivision and leasing of land, this could simply be accomplished by the property owner granting exclusive possession over a portion of their land to a tenant by way of a lease and everyone was happy. Everyone that is but the local and provincial governments ...
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 ...
Disputes are the bane of all construction professionals lives, but unfortunately no matter how hard one tries to avoid them (partnering, mediation and the like) there are always some matters which require formal dispute resolution to resolve them. PFI is one area where efforts have been made in the last few years to streamline disputes and where appropriate to consolidate disputes. While such aims are to be applauded they can in themselves lead to difficulties ...
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 ...
There are a number of legal mechanisms that can improve the economics and liability of industrial and commercial development projects for developers willing to take advantage of them. This article will explore some of the incentives available to developers that will assist in maximizing profits and freeing-up capital that would otherwise be devoted to conventional construction or permanent loan financing. 1. Tax Incremental Financing Districts (“TIF’s”) ...
ALERT Hospital May Be Excluded For Physician Recruiting On May 8, 2006 the OIG announced that it intends to exclude San Diego-based Alvarado Hospital from participation in Medicare, Medicaid and all other federal health care programs because of payments the Hospital made under relocation agreements involving placement of newly-recruited physicians in established physician practices ...
Certificate of Need Strategies for New Nursing Home Beds Special Population Beds are Re-Approved At its March 2006 meeting, the Michigan Certificate of Need (“CON”) Commission took action to re-approve several state-wide pools of nursing home beds that are set aside to serve special populations, including: Alzheimer’s Use 60 beds Hospice 30 beds Religious Use 20 beds The Commission reserved 22 special population beds on a non-specified basis for future use ...
IN OUR JUNE 2005 “FDA WATCH” column, we provided an overview of the regulatory, political, and scientific landscape for follow-on biological products in the U.S. As reported a year ago, the biogenerics debate centers around whether generic biologics are scientifically possible (i.e ...
Scope of this treatiseThe purpose of this discussion is to address those cases which are most likely to have a significant effect for those practicing in the chemical, pharmaceutical and biotech areas ...
The Planning and Development (Strategic Infrastructure) Bill 2006 was published on 16 February 2006 (a pdf version of this Bill is available at the end of this article). The idea of creating a “fast track” planning procedure for major infrastructural projects had been mooted for over three years ...
