lunes, 23 de enero de 2012

Regulatory history

Throughout history, governments have regulated food and drug products. In general, the focus of this regulation has been on ensuring the quality and safety of food and drugs. Food and drug regulation as we know it today in the United States had its roots in the late nineteenth century when state and local governments began to enact food and drug regulations in earnest. Federal regulation of the industry began on a large scale in the early twentieth century when Congress enacted the Pure Food and Drugs Act of 1906. The regulatory agency spawned by this law – the U.S. Food and Drug Administration (FDA) – now directly regulates between one-fifth and one-quarter of U.S. gross domestic product (GDP) and possesses significant power over product entry, the ways in which food and drugs are marketed to consumers, and the manufacturing practices of food and drug firms. This article will focus on the evolution of food and drug regulation in the United States from the middle of the nineteenth century until the present day.

Canada Food and Drugs Act Liaison Office

About Health Canada

Food and Drugs Act Liaison Office

Who we are

The role of the Food and Drugs Act Liaison Office is to improve relations between external stakeholders and representatives of Health Canada, as well as to increase the openness and transparency in the regulatory process.
We are an impartial and confidential resource for individuals, business and organizations when they experience problems with how Health Canada administers the Food and Drugs Act.

What we do

We receive complaints, concerns or enquiries about alleged acts, omissions, improprieties and broader systemic problems on matters pertaining to the Food and Drugs Act.
We listen, offer options, facilitate communication, and examine issues impartially.
We act as an intermediary and help the parties arrive at a mutually agreed upon resolution.
We help prevent similar issues by making recommendations to the Department.

How we can help you

Our conflict resolution specialists offer a range of flexible services to help you with concerns about how Health Canada administers the Food and Drugs Act.
You might be
  • A business owner unhappy with the way a licensing decision was made
  • An individual concerned about the process for approving a drug or other product
  • A stakeholder frustrated by the communications between you and the department
  • Someone having trouble with the regulatory process or enforcement of the Food and Drugs Act
We can
  • Work with you to address the issue in a confidential and impartial manner;
  • Liaise between you and Health Canada;
  • Facilitate meetings between you and Health Canada; and
  • Provide mediation services to help you and Health Canada staff resolve issues quickly and efficiently.
Our past work provides examples of how we can help in various situations.

Related Resources

For questions about Health Canada's programs and services you can call (866) 225-0709, or contact General Inquiries.
For concerns or complaints about a food product, please Next link will take you to another Web site contact the Canadian Food Inspection Agency.
For information on Health Canada's enforcement and compliance activities or to place a trade or consumer complaint related to the products and devices covered under the Food and Drugs Act, please visit the Compliance and Enforcement section.
To report an adverse reaction or side effect from a drug or health product, go to the MedEffect Canada Web site (

mental Acerca de las ENT Países Temas de salud Publicaciones Informe sobre la situación mundial de las enfermedades no transmisibles 2010

Enfermedades no transmisibles y salud mental

Informe sobre la situación mundial de las enfermedades no transmisibles 2010

Resumen de orientación



En este informe se presentan los datos estadísticos, la evidencia y las experiencias necesarias para poner en marcha una respuesta más contundente a la amenaza creciente que plantean las enfermedades no transmisibles. Los consejos y recomendaciones formuladas tienen interés universal, pero el informe presta especial atención a la situación de esas enfermedades en los países de ingresos bajos y medios, que soportan actualmente casi el 80% de la carga de morbilidad por dolencias como los trastornos cardiovasculares, la diabetes, el cáncer y las enfermedades respiratorias crónicas. Se abordan también las consecuencias sanitarias de la epidemia mundial de obesidad
El informe aplica un enfoque analítico, utilizando datos mundiales, regionales y específicos de los países para documentar la magnitud del problema, prever futuras tendencias y evaluar los factores que explican esas tendencias. Según se señala, la epidemia de estas enfermedades se ve avivada hoy por factores poderosos que afectan a todas las regiones del mundo: el envejecimiento demográfico, la urbanización rápida y no planificada, y la mundialización de modos de vida malsanos. Muchas enfermedades crónicas evolucionan lentamente, pero los modos de vida y los comportamientos están cambiando a una velocidad y con un alcance sorprendentes.

FAO-EC project to promote climate-smart farming

FAO-EC project to promote climate-smart farming

Malawi, Vietnam and Zambia will benefit from collaborative effort

Photo: ©FAO/Noah Seelam
Farmers participating in an FAO land and water management project in Guthi, India, check a new drip irrigation system.
16 January 2012, Rome - FAO and the European Commission announced today a new €5.3 million project aimed at helping Malawi, Vietnam and Zambia transition to a "climate-smart" approach to agriculture.

Agriculture — and the communities who depend on it for their livelihoods and food security — are highly vulnerable to climate change impacts. At the same time agriculture, as a significant producer of greenhouse gases, contributes to global warming.

"Climate-smart agriculture" is an approach that seeks to position the agricultural sector as a solution to these major challenges.

It involves making changes in farming systems that achieve multiple goals: improving their contribution to the fight against hunger and poverty; rendering them more resilient to climate change; reducing emissions; and increasing agriculture's potential to capture and sequester atmospheric carbon.

"We need to start putting climate-smart agriculture into practice, working closely with farmers and their communities," said FAO Assistant Director-General for the Economic and Social Development Department, Hafez Ghanem. "But there are no one-size-fits-all solutions — better climate-smart farming practices need to respond to different local conditions, to geography, weather and the natural resource base," he added.

"This project will look closely at three countries and identify challenges and opportunities for climate-smart agriculture and produce strategic plans tailored to each country's own reality," Ghanem said. "While not all solutions identified will be universally applicable, we can learn a lot about how countries could take similar steps and begin shifting to this approach to agriculture."

martes, 17 de enero de 2012

Germany - GM Food regulations

Germany - GM Food regulations

The German Minister for Agriculture Ilse Aigner has presented a standardised logo for food products ‘without gene technology’.Improvement of the poor acceptance of the ‘without gene technology’ label is expected, reports GMO Compass. To date, only a few manufacturers have made use of this tag.
Since May 2008, it has been possible in Germany to apply the label ‘without gene technology’ to food products. Its primary application is in the identification of foods, such as meat, derived from animals for which no GM plants such as maize or soy were used in the feed. However, in contrast to other foodstuffs, a declaration of being ‘without gene technology’ is also permitted for animal-based products even in the case that vitamins, enzymes or other additives manufactured with gene technology were present in feed.
The criteria are stricter for other foodstuffs: neither the application of additives obtained through genetic modification nor the accidental admixture of GM plants is allowed, reports continue. To date, however, products ‘without gene technology’ have not been broadly available. With the exception of a dairy commodity from the Campina, the products to which this declaration has been applied generally are made by small, regional manufacturers.
With the presentation of a standardised logo, Minister Aigner stated the goal of  "making it easier for consumers to choose food products without gene technology in an informed manner". The minister also indicated its provision of "more freedom of choice" and its "enhancement of transparency when shopping for groceries". The new logo is expected to be made available to interested manufacturers free of charge.

FDA Panelists Had Ties to Bayer

Food and Drug Administration advisers, in a recent vote, said the benefits of four popular Bayer AG birth-control pills outweigh the blood-clot risk. What the FDA didn't disclose is that three of the advisers have had ties to Bayer, serving as consultants, speakers or researchers.
The three doctors were members of a special safety committee convened last month to assess the safety of the products, called Yaz, Yasmin, Beyaz and Safyral. Bayer's own studies show no excess danger, but other research including an FDA-commissioned study suggests there is one.

National Policy on Traditional Medicine and Regulation of Herbal Medicines - Report of a WHO Global Survey

National Policy on Traditional Medicine and Regulation of Herbal Medicines - Report of a WHO Global Survey

Executive summary
Traditional medicine (TM) has always maintained its popularity worldwide. In addition, over the last decade, we have seen an increasing use of complementary and alternative medicines (CAM) in many developed and developing countries. The safety and efficacy of traditional medicine and complementary and alternative medicines, as well as quality control, have become important concerns for both health authorities and the public.
Various traditional medicine practices have been developed in different cultures in different regions, but without a parallel development of international standards and appropriate methods for evaluating traditional medicine Therefore, sharing national experience and information is crucial.
Countries face major challenges in the development and implementation of the regulation of traditional, complementary/alternative and herbal medicines. These challenges are related to regulatory status, assessment of safety and efficacy, quality control, safety monitoring and lack of knowledge about TM/CAM within national drug regulatory authorities.
Challenges related to the regulatory status of herbal medicines: Before manufactured drugs came into widespread use, herbal medicines played an important role in human health. There are great differences between Member States in the definition and categorization of herbal medicines A single medicinal plant may be defined as a food, a functional food, a dietary supplement or a herbal medicine in different countries, depending on the regulations applying to foods and medicines in each country. This makes it difficult to define the concept of herbal medicines for the purposes of national drug regulation, and also confuses patients and consumers.
Challenges related to the assessment of safety and efficacy: Requirements and methods for research and evaluation of the safety and efficacy of herbal medicines are more complex than those for conventional pharmaceuticals. A single medicinal plant may contain hundreds of natural constituents, and a mixed herbal medicinal product may contain several times that number. If every active ingredient were to be isolated from every herb, the time and resources required would be tremendous. Such an analysis may actually be impossible in practice, particularly in the case of mixed herbal medicines.
Challenges related to quality control of herbal medicines: The safety and efficacy of herbal medicines is closely correlated with the quality of the source materials used in their production. The quality of source materials is, in its turn, determined by intrinsic factors (genetic) and extrinsic factors (environmental conditions, cultivation and harvesting, field collection and post harvest/collection transport and storage). Therefore, it is very difficult to perform quality controls on the raw materials of herbal medicines.
Good Manufacturing Practice (GMP) specifies many requirements for quality control of starting materials, including correct identification of species of medicinal plants, special storage and special sanitation and cleaning methods for various materials. In the quality control of finished herbal medicinal products, particularly mixed herbal products, it is more difficult to determine whether all the plants or starting materials have been included.
Challenges related to safety monitoring of herbal medicines: Adverse events arising from consumption of herbal medicines may be due to any one of a number of factors. These include the use of the wrong species of plant by mistake, adulteration of herbal products with other, undeclared medicines, contamination with toxic or hazardous substances, overdosage, misuse of herbal medicines by either health care providers or consumers and use of herbal medicines concomitantly with other medicines. Therefore, analysis of adverse events related to the use of herbal medicines is more complicated than in the case of conventional pharmaceuticals. Furthermore, herbal medicines are often used for self care; thus, there is a great need to educate consumers and public in their proper use.
Lack of knowledge about herbal medicines within national drug authorities: The general lack of knowledge about herbal medicines within national drug authorities and the lack of appropriate evaluation methods are factors that delay the creation or updating of national policies, laws and regulations for traditional medicines, contemporary/alternative medicines and herbal medicines.
In order to meet these challenges, the WHO Traditional Medicine Strategy was developed, with its four primary objectives: framing policy; enhancing safety, efficacy and quality; ensuring access; and promoting rational use Resolution WHA56.31 on traditional medicine was adopted at the Fifty-sixth World Health Assembly in May 2003. The resolution requested WHO to support Member States by providing internationally acceptable guidelines and technical standards and also evidence based information to assist Member States in formulating policy and regulations to control the safety, efficacy and quality of traditional medicines.
Global Survey and Database
WHO decided to conduct a global survey on national policies on TM/CAM and regulation of herbal medicines and store the results in a global database. In 2001, WHO developed the Global Survey questionnaire, which focused on the main challenges listed above. The questionnaire was divided into three main parts:
• general review of policy and regulation of TM/CAM
• regulation of herbal medicines
• countries’ needs for future WHO support and technical guidance

We received responses from 141 countries, representing 74% of the 191 Member States of WHO at that time. The data were entered into the WHO Global Database developed for the survey. The information in the database is listed under 21 qualitative and quantitative structural indicators, which are intended to assess the situation of TM/CAM policies and herbal medicine regulation. Analysis of the survey results will provide the basis for further development of a comprehensive set of indicators, including background and process indicators for the monitoring of national TM/CAM policies and herbal medicine regulation.
Structure of report
This report is in four parts, covering national policy on traditional medicine and complementary/alternative medicine; regulation of herbal medicines; difficulties encountered by Member States and their needs for WHO support; summary of each country profile, classified by WHO region.
National policy on traditional medicine and complementary/alternative medicine: A national policy on TM/CAM may include some of the following key elements: a definition of TM/CAM, provision for the creation of laws and regulations, consideration of intellectual property issues. The policy may further describe the main strategies proposed by the government for achieving the objectives of the policy Forty five (32%) of the responding Member States reported having a policy on TM/CAM. Of those Member States which currently do not have a national policy, 51 (56%) indicate that such policies are currently being developed. Most Member States with a national policy established it recently, since only five States reported having a national policy before 1990. Forty Member States (28%) reported that they had issued a national programme on TM/CAM. Seventy five countries (53% of the responding Member States) reported having a national office in charge of TM/CAM. In most of these countries, the national office is located within the Ministry of Health Sixty one countries (43% of the responding Member States) reported that they have expert committees for TM/CAM. In all, 58 Member States indicated that they had at least one national institute on TM, CAM or herbal medicines.
Regulation of herbal medicines: This section is the central part of the Global Survey. It contains a great deal of detailed information related to regulation of herbal medicines, e.g. regulatory status of herbal medicines, regulation requirements, number of registered herbal medicine products and quality control requirements such as GMP, monographs, etc. Before 1988, there were only 14 Member States with regulations relating to herbal medicines, but the figure increased to 53 Member States (37%) having laws and regulations in 2003. Of those Member States without current laws or regulations, 42 (49%) declared that these regulations were in the process of being developed. Such results show that Member States are increasingly involved in developing the regulation of herbal medicines.
The questions about the regulatory status of herbal medicines also show, interestingly, that in most Member States (97 out of 142 respondents) herbal medicines are sold as over the counter medicines, in contrast to 50 Member States where herbal medicines are also sold as prescription medicines. Medical claims, health claims and nutrients contents claims are the most common types of claims with which herbal medicines may legally be sold (90 Member States allow medical claims, 62 allow health claims and 49 allow nutrient content claims).
The collected information about herbal medicines also shows that 86 Member States (61%) have a registration system for herbal medicines and 17 have 1 000 or more registered herbal medicines. Judging from these data, many Member States are giving the regulation of herbal medicines careful consideration.
Difficulties encountered by Member States and needs for WHO support: This survey demonstrates that Member States have made progress over recent years. However, there are still difficulties in the regulation and harmonization of TM/CAM worldwide. The survey also identifies the main difficulties regarding regulatory issues for herbal medicines - lack of research data, lack of appropriate control mechanisms, lack of education and training and lack of expertise. In this regard, Member States requested WHO to continue providing support for those countries endeavouring to develop a national policy and regulations on TM/CAM.
Summary of each country profile classified by WHO region: The country summaries follow a generalized template, including the status and year of establishment of the following: policy on TM/CAM (national policy, law/regulation, national programme, national office, and national institutes) and the regulation of herbal medicine (law/regulation, regulatory status types, claim types, pharmacopoeia and monographs used, manufacturing requirements and control mechanisms, safety requirements and control mechanisms, registration system, essential drug list, post marketing surveillance, marketing site and annual sales). These summaries are available for all 141 countries that responded to the survey.
Table 1. Survey return on selected topics, with regional breakdown
Survey response
National policy on TM/CAM
Law or regulation on TM/CAM
National programme on TM/CAM
National office for TM/CAM
Expert committee on TM/CAM
National research institute on TM, CAM or herbal medicines
Law or regulation on herbal medicines
Registration of herbal medicines

1 AFRO: WHO Regional Office for Africa; AMRO: Regional Office for the Americas; EMRO: Regional Office for the Eastern Mediterranean; EURO: Regional Office for Europe; SEARO: Regional Office for South-East Asia; WPRO: Regional Office for the Western Pacific.

Table 2. Regional breakdown of responding countries
African Region
Region of the Americas
Eastern Mediterranean Region
European Region
South-East Asia Region
Western Pacific Region
Angola Antigua & Barbuda Afghanistan Armenia Bangladesh Australia
Benin Argentina Bahrain Austria Bhutan Cambodia
Botswana Bolivia Djibouti Azerbaijan Dem. People’s Rep of Korea China
Burkina Faso Brazil Egypt Belarus India Cook Islands
Burundi Canada Iran (Islamic Rep of) Belgium Indonesia Fiji
Cameroon Chile Jordan Bulgaria Maldives Japan
Central African Rep Colombia Kuwait Czech Republic Myanmar Kiribati
Chad Costa Rica Libyan Arab Denmark Nepal Lao People’s Democratic Rep
Comoros Dominica Oman Estonia Sri Lanka Malaysia
Congo Dominican Republic Pakistan France Thailand Micronesia (Federated States of)
Côte d’Ivoire Ecuador Qatar Georgia   Mongolia
Democratic Rep. of the Congo El Salvador Saudi Arabia Germany   Nauru
Equatorial Guinea Guatemala Sudan Hungary   New Zealand
Ethiopia Jamaica Syrian Arab Republic Iceland   Niue
Gabon Mexico United Arab Emirates Ireland   Papua New Guinea
Gambia Nicaragua Yemen Israel   Philippines
Ghana Peru   Kazakhstan   Rep of Korea
Guinea Suriname   Kyrgyzstan   Singapore
Guinea Bissau     Latvia   Solomon Islands
Kenya     Lithuania   Tuvalu
Madagascar     Netherlands   Vanuatu
Malawi     Norway   Viet Nam
Mali     Portugal    
Mauritania     Rep of Moldova    
Mozambique     Romania    
Niger     Russian Fed    
Nigeria     Serbia & Montenegro    
Rwanda     Slovakia    
Sao Tome & Principe     Slovenia    
Senegal     Spain    
Seychelles     Sweden    
Sierra Leone     Switzerland    
South Africa     Tajikistan    
Togo     The former Yugoslav Rep of    
United Rep of Tanzania     Turkey    
Uganda     Ukraine    
Zambia     United Kingdom of Great Britain & Northern Ireland    
Member States
(80% of 46)
Member States
(51% of 35)
Member States
(76% of 21)
Member States
(73% of 52)
Member States
(100% of 10)
Member States
(81% of 27)
Total respondents: 141

lunes, 16 de enero de 2012


Following the trend of previous years, local exchange carriers are still transitioning from traditional forms of rate
regulation−i.e. rate-of-return regulation (ROR)−towards alternative forms of regulation, including rate freeze, price caps,
flexible regulation and deregulation. Among these regulatory regimes, price cap regulation is the most commonly adopted
by states to regulate the rates of their incumbent local exchange carriers, particularly of larger incumbents.
The enclosed tables and figures show the status of retail rate regulation of local exchange carriers in the United
States as of September 2004. The information included in this report was obtained from the Supplemental White Papers
on Retail Rate Regulation of Local Exchange Providers, published each year by State Telephone Regulation Report. Staff
members from 32 states and the District of Columbia reviewed this information and provided revisions, improving the
accuracy of the report.
A total of 37 states use some form of price cap regulation (see Table 1 and Figure 1). Of them, only six states (AL,
DE, DC, LA, RI and TX) apply it to all their ILECs, including Regional Bell Operating Companies (RBOCs) and other
competitors. The most common trend is for the states to regulate the rates of their large incumbents under a price cap
plan while maintaining their smaller incumbents under ROR regulation (18 states); other states have granted smaller
incumbents flexible regulation or rate deregulation, either partial or complete, while regulating large ILECs under price
caps (7 states). As it is explained in Table 4, many small incumbents can opt to change to price caps or some other form
of alternative regulation, but many have decided to remain under traditional forms of regulation. Finally, the remaining six
states (AR, KY, MN, NY, ND, and OR) use a mix of regimes, including price caps, to regulate both their large and small
Despite the prevalence of price caps, traditional rate of return regulation (ROR) is still in use in 36 states, mostly to
regulate smaller incumbents, as illustrated in Figure 2. The number of states that use ROR for all their ILECs has
decreased over time; as of September 2004, only Alaska, Hawaii, Montana, New Hampshire and Washington did so.
Arizona and Idaho are special cases; both states use ROR for all their ILECs, but Qwest is under hybrid plans that
combine ROR with price caps in Arizona and with deregulation in Idaho.

 An increasing tendency among states is to apply different regulatory regimes to each of their incumbent local
exchange carriers, combining price caps with ROR, price flexibility and deregulation, as shown in Tables 1 and 2, and in
greater detail in Table 4. As of September of 2004 eleven states were using a combination of regimes to regulate the
ILECs providing service in their territories.
Classifying carriers under a specific type of rate regulatory regime has become more difficult in recent years, as
more states implement alternative regulation plans. These plans combine features of different regulatory regimes, such as
rate freeze, price cap regulation or even rate-of-return regulation with pricing flexibility or deregulation, so as to adequately
respond to the increasing level of competition faced by a particular carrier in its different baskets of services.
Massachusetts, New York, Ohio, Pennsylvania and Wyoming are cases in point. As a result of these combinations, a
single label such as price cap plan or deregulation becomes inadequate to appropriately define the characteristics of
these hybrid alternative regulation plans. Finally, complete rate deregulation has been implemented only in Nebraska and
more recently in South Dakota, states where Qwest is the largest ILEC.
With respect to the competitive local exchange carriers (CLECs), the prevalent regulatory trend is rate flexibility (27
states), closely followed by rate deregulation (21 states), as illustrated in Table 1 and Figure 3. This trend is based on the
assumption in most states that the retail rates of CLECs are competitive. Only three states (DE, NJ and VA) impose some
regulations over CLEC rates, either by capping the rates for some services at the incumbent’s level or by stetting costbased
floors. Regardless of the type of rate regulation they operate under, CLECs are required in most states to obtain
state certification by demonstrating technical, financial and managerial competence before beginning operations in the
state. Only Kentucky, Massachusetts, Montana and Washington allow CLECs to operate by simply registering with the
public commission or another appropriate authority; North Dakota requires certification only to facilities-based CLECs. As
for the requirements to file tariffs and notify rate and service changes, Montana, Nevada, North Carolina and Oregon
provide their CLECs the greatest flexibility, even when compared to states that do not review CLECs’ rates. Competitive
carriers in these four states are not required to file tariffs or provide notification of changes and the rate changes are not
normally reviewed by their respective state commission. Table 5 provides greater detail on the state commission
requirements on CLECs regarding certification, rate filings, rate changes, reviews and notifications.
Table 3 presents the major changes in retail rate regulation that occurred since April of 2003. During the 2003-
2004 period, the rate plans of major ILECs in 14 states (AZ, CA, CO, DE, IL, KY, LA, MN, MS, NC, OK, SC, WV and WI)
and the District of Columbia went under review and the majority of these plans were extended with some changes. New
plans were established for major ILECs in Indiana (SBC, VZ, and Sprint), Kentucky (Alltel KY) and Massachusetts (VZ),
while state commissions in Maryland, Vermont, Virginia and North Carolina opened dockets to evaluate existing plans for Verizon (MD, VT) and Sprint (NC) or, as in the case of Virginia, new price cap plans for Verizon VA and Verizon South. In
fact, Verizon’s rate plans and proposals were reviewed or are currently been reviewed in 21 of the 42 states reporting
changes since April of 2003, the highest number among Regional Bell Operating Companies (RBOCs).
Nevertheless, among the RBOCs, Qwest had the most radical changes in its rate regulation during the 2003-2004
period, changes justified by the increased presence of competition in its area of service. This carrier filed proposals for
deregulation or greater price flexibility in eight of its fourteen regional states (AZ, CO, ID, MN, SD, UT, WA and WY).
Although Qwest’s application for full rate deregulation in the seven largest exchanges in Idaho was unsuccessful, it won
statewide retail rate deregulation from the South Dakota PUC in October of 2003, making it the only RBOC having
obtained full retail rate deregulation in two of its regional states (NE and now, SD). Qwest is also requesting full price
flexibility for all retail services in competitive zones in Arizona, and for all but basic services in Colorado; it was granted
deregulation for business rates in three major metropolitan areas in Minnesota and of all analog business telecom
services in all markets in Washington; it increased the number of rate deregulated local residential lines in the most
populated areas of Utah, and moved from a price cap plan to a cost-based pricing flexibility regime in Wyoming, all since
April 2003.
SBC and Verizon are also following this trend, proposing full deregulation of retail rates in Missouri and Maryland,
respectively. In Massachusetts, Verizon’s new alternative regulation plan provides it greater flexibility for pricing nonbasic
residential and all business services, while a plan proposed by the company in Vermont would grant it rate
deregulation for all but basic residential services, if approved. BellSouth has also made inroads towards retail rate
deregulation in North and South Carolina during this period. In North Carolina it proposed a reclassification of services for
its price cap plan that would move most services into the full pricing flexibility category; meanwhile, in South Carolina, the
Legislature enacted rate deregulation for all retail service bundles from price-regulated incumbents (BS, VZ and Sprint),
and the state government has until the end of 2004 to act on the measure.
Among the states reporting changes during this period, Alabama is conducting the most comprehensive review of
regulation. The Public Service Commission opened a comprehensive regulatory review (Case 28950) of all local
exchange providers to determine if the technological, structural and policy changes that occurred since the 1996 Telecom
Act require a corresponding regulatory change. In the proposed plan, carriers would be regulated according to level of
competition they are facing. In sum, the trend among states is towards providing greater price flexibility to incumbent carriers as the level of
competition in local exchange services increases in their regional areas. This flexibility is expressed either by deregulating
certain services, such as non-basic and competitive services, or certain carriers based on their size, such as telephone
cooperatives and other smaller incumbents. Some larger incumbents are also making inroads in achieving full retail rate
deregulation in competitive zones. As for CLECs, rate flexibility is the prevailing trend.
The tables included in this report provide different levels of detail. Table 1 presents a distribution of the states by
type of rate regulation regime applied to their ILECs and CLECs. Figures 1 and 3 illustrate this information. Table 2
provides basic information on the specific type of plan applied to large incumbents, other incumbents and CLECs. Table
3 summarizes major changes in rate regulation that occurred since April 2003. Tables 4 and 5 provide more detailed
information on the specifics of the retail rate regulation plans of ILECs and CLECs, respectively, including earnings
regulation, notice periods, as well as requirements on infrastructure investment and quality of service.

Clinical trials for medicines: UK clinical trial authorisation assessment performance

Clinical trials for medicines: UK clinical trial authorisation assessment performance

Clinical trials - Young scientistThese measures of performance are intended to provide guidance to clinical trial sponsors on performance in terms of determination (acceptance, grounds for non-acceptance) for applications for clinical trial authorisations.
The charts will be updated monthly to present performance over the current business year (April to March). Historical data from implementation of the Clinical Trials Directive (1 May 2004) are also provided. As these data accumulate, the presentation will be on a five year rolling basis.
The data provided below details the number of applications assessed by MHRA, split by phase and commercial and non-commercial sponsors, with the exception of the GNA breakdown. Please note: the 2005 and 2006 data is only available as Phase I and Phase II/III/IV as the applications were not separated out any further at this time.
 The phase of application correlates with the phases described in The Medicines (Products for Human Use) (Fees) Regulations and not the phase described by the applicant on their application form.

Clinical trials for medicines

Clinical trials for medicines

Before a medicine can be authorised for use, it must go through the clinical trials process to ensure that it is safe and effective and also that the quality of the product is sufficient.
This section contains information on every aspect of the clinical trials process.
12 October 2011: Guidance on risk-proportionate approaches to the management and monitoring of clinical trials has now been included in Appendix 2 of the MRC/DH/MHRA Joint Project document "Risk-adapted Approaches to the Management of Clinical Trials of Investigational Medicinal Products".
Please refer to our pages on submitting a notification for a trial for more information.

sábado, 14 de enero de 2012

European Medicines Agency starts review of aliskiren-containing medicines following termination of ALTITUDE study

European Medicines Agency starts review of aliskiren-containing medicines following termination of ALTITUDE study

Interim advice while review is ongoing
The European Medicines Agency is reviewing aliskiren-containing medicines, to assess the impact of data coming from the ALTITUDE study on the balance of benefits and risks of these medicines in their approved indication.
Aliskiren-containing medicines are approved for the treatment of essential hypertension. ‘Essential’ means that there is no obvious cause for high blood pressure.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) started the review after it was informed on 19 December 2011 by the marketing authorisation holder of the decision to terminate the ALTITUDE study early. This clinical trial included patients with type 2 diabetes and renal impairment and/or cardiovascular disease. In most patients arterial blood pressure was adequately controlled. The patients included in the trial received aliskiren in addition to either an angiotensin converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB).
Termination of the placebo-controlled phase III trial was recommended by the independent Data Monitoring Committee overseeing the study, because the results showed that there was no benefit with aliskiren and that there were more cases of stroke, renal complications, hyperkalemia and hypotension in patients who received aliskiren compared with patients who received a placebo.
The information available at present is limited. The Committee has asked the company to provide additional analyses to allow the CHMP to assess the impact of the results of the ALTITUDE trial on the overall benefit-risk profile of aliskiren-containing medicines and to determine the need for regulatory action.
Interim advice for doctors and patients
While the review is ongoing the CHMP recommends, as a precautionary measure, that doctors should not prescribe aliskiren-containing medicines to diabetic patients in combination with ACE inhibitors or ARBs.
Doctors should therefore review the treatment of patients taking aliskiren at a routine (non-urgent) appointment, and if patients are diabetic and are also taking ACE inhibitors or ARBs, aliskiren should be stopped and alternative treatments considered.
Patients should not stop any of their treatment before speaking to their doctor, because stopping anti-hypertensive medication without medical supervision can put them at risk. They are advised to discuss their treatment with their doctor at their next scheduled (non-urgent) appointment.
Patients in clinical trials with aliskiren should contact their study site for guidance on their medication.
Further information on the review of aliskiren-containing medicines will be provided when available.
Que´buena campaña contra la diabetes!!!!!!!!!!
Campanha antiobesidade mostra diabético que teve a perna amputada por excesso no consumo de açúcar
Como recuerda la OMS - WHO


La obesidad y el sobrepeso se definen como una acumulación anormal o excesiva de grasa que puede ser perjudicial para la salud. Una forma simple de medir la obesidad es el índice de masa corporal (IMC), esto es el peso de una persona en kilogramos dividido por el cuadrado de la talla en metros. Una persona con un IMC igual o superior a 30 es considerada obesa y con un IMC igual o superior a 25 es considerada con sobrepeso. El sobrepeso y la obesidad son factores de riesgo para numerosas enfermedades crónicas, entre las que se incluyen la diabetes, las enfermedades cardiovasculares y el cáncer.

Global Conflict Simmers Despite Lack of Open War: "An Attack on Iran is likely to Happen in 2012"

Global Research, January 12, 2012


As summarized in 1986 by Zbigniew Brzezinski, former US national security advisor, the national interest of the US lies in three fronts...Today, the US has been carrying out strategies on all the three fronts. It has further squeezed Russia's space through NATO expansion. The "return to Asia" has stirred up huge waves of tension around China.

In the Islamic world, the US has brought down Iraq, Libya, Sudan, and Yemen. Now it is pressuring Syria and Iran, as well as Pakistan.

Lately in the discussion of international affairs and China's response, voices advocating "hiding one's capabilities and biding one's time" still dominate.

But as I see it, national strategy should not be a static matter. It should be subject to changes, particularly to the changes of the global political sphere.

It is absolutely right for China to stick to the path of peaceful development. Meanwhile, however, we should still keep a cool and watchful mind when dealing with international affairs.

Contrary to what many people had expected, conflict remained after the end of the Cold War, and many confrontations escalated into warfare years after.

As summarized in 1986 by Zbigniew Brzezinski, former US national security advisor, the national interest of the US lies in three fronts. The first is the far west where Eastern Europe is the focal point. The second is the far east, where conflicts are centered in countries such as Japan, China and North Korea, and key points of interest lie in South Korea, the Philippines, and Taiwan Island. The third lies in the southwest, where the strategic focuses of the US are Afghanistan, Iran and Pakistan.

Today, the US has been carrying out strategies on all the three fronts. It has further squeezed Russia's space through NATO expansion. The "return to Asia" has stirred up huge waves of tension around China.

In the Islamic world, the US has brought down Iraq, Libya, Sudan, and Yemen. Now it is pressuring Syria and Iran, as well as Pakistan.

I'd like to call this perpetual state of global conflicts "warm war."

It is more heated and noticeably obvious than the silent confrontation of the cold war, despite lacking blatant display of open fire.

However, it can still be regarded as a type of warfare in a broader sense.

I believe a US war with Iran is likely to happen this year.

The US is trying to achieve its ultimate goal as one of its global strategies. Both US and Europe need to get rid of the current financial mire. Israel worries that its national security is at stake. The current sanctions the West has forced upon Iran can actually be seen as a declaration of war.

The preparation for this war has been going on for years in the form of espionage, Internet attacks, assassinations, and all sorts of manipulations the US has played on the country's psyche.

To be fair, not only the US but also Israel and Iran are preparing for this war. So is Russia, which sees great potential in this conflict. Pakistan may also be drawn into trouble by the US as the US has much to gain if Pakistan is mired in social unrest.

The US has wanted for years to take over Pakistan, which is the only Islamic country that has nuclear weapons. 

Another hidden agenda the US has is to cut off China's access to the Indian Ocean so as to stop the trading activities China has with the Islamic world. The strategy of the US may also involve North Korea, which is in its post Kim Jong-il era, and Myanmar, which is strategically important to China.

As one can see, due to the strategic manipulations of the US, 2012 will not be a year of world peace. It's possible that the world can't walk out of the shadow of war in the following years.

Alarmingly, US Republican candidate Jon Huntsman said in the CBS TV debate that "We should be reaching out to our allies and constituencies within China [...who] are bringing about change, the likes of which is gonna take China down."

It cannot be clearer that US politicians are never in favor of allying with China for mutual interest.

Since China's reform and opening-up, China has rarely mentioned the idea of "three worlds," and it always favors the policy of not forming cliques and non-confrontations.

The purpose of this article is not to provoke conflict or encourage confrontation, but to remind our fellow countrymen to be more clear-headed about the US' hidden agenda, and to have a firm grasp of the global picture.

The author is a research fellow at the China Center for Strategic Studies at Peking University.