Pilot project on regulatory harmonization for single global guideline underway in Asia Pacific

Pharmaceutical sector which is now toying with the concept of a single global regulatory guideline has kicked off an initiative in the Asia Pacific region. In the ASEAN region, 10 countries have come together to initiate the process of harmonization.
A pilot project is underway in the Asia- Pacific region to ensure regulatory harmonization. This covers the China-Japan-Korea Tripartite for a joint research project on ethnic factors in clinical trials. In the China-Taiwan region a cross-strait Medical and Healthcare Co-operation agreement is being developed. Taiwan has proposed for the APEC PER (Pharmaceutical Evaluation Report) Scheme.
The harmonization initiatives by WHO – United Nations, ICH – USA, EU and Japan, EC/EMEA – Members of European Union, PIC/S – 35 participating countries and PANDRH – Pan American countries are on track.

“A harmonized regulatory environment would reduce the time to market the product by eliminating undue or perhaps unjustified country-specific requirements. It would provide transparent requirements which simplifies market access and expedites patients’ access to new and innovative technologies,” stated Kaushik Desai, director, DIA India, vice president and chairman, Industrial Pharmacy Division, Indian Pharmaceutical Association (IPA).
“Further, a uniform international regulatory system would also reduce the cost to market a product. It reduces unwarranted, often contradictory guidelines and redundant applications of similar requirements which leads to different product definitions in various geographies, further complicates follow-up and comparison of data on safety issues. Overall it would enhance the utilization of already stretched and limited human and financial resources. Facilitating cooperation among regulators and the industry in conducting activities like common audits and exchange of safety information can be leveraged on experience gained over time,” he added.
The creation of common requirements to address product life cycle development, manufacture and post-market surveillance would considerably reduces the burden, complexity, and unpredictability to seek clearance. The setting up of a premarket evaluation, uniform quality system and common clinical safety performance would only drive efficiency in the system, pointed out Desai.
Going by the current demand for an increasingly global environment and the need to integrate national and international standards in a universally acceptable format for the participating countries would facilitate well-organized global drug development and local registration. While every regulatory agency across US, EU, Japan and Asia share the same objective of ensuring safety, efficacy and quality of drug product, the issue today is that legislations and regulations differ. This is where globalization would lead to harmonization, said Desai.
So long individual country strategies saw little global cooperation. The regulations from US, EU and Japan dominated the pharma industry. There was also a serious lag in the development of medicines in Asia. But this scene has transformed creating a space for an increasingly harmonized environment for regulations. For instance, the growing multi-regional clinical trials haveincreased discussions on acceptability of foreign clinical data and demand to bridge studies. Future regulations indicate need for a single global regulatory guideline. The move has the acceptance of global data and authority cooperation. Newer paradigms for the future are the harmonization of Good Manufacturing Practices which will enable effective consolidation in manufacturing activities. A single facility could begin catering to multiple regions and later to the entire world. The engines of change in the regulatory landscape have started chugging off with the US FDA - Pharmaceutical cGMPS for the 21ST century, ICH, Q8 –Pharmaceutical Development, Q9 - Quality Risk Management, Q10 - Quality Management System, Q11 - manufacture of drug substances and issue of New Dietary Ingredient Notifications, he said.
Source:Pharmabiz

Healthy Eating Keeps Elders Mentally Sharper: Study

Elderly people who ate healthy food and had higher levels of certain vitamins and omega 3 fatty acids in their blood scored better on mental acuity tests than those who ate junk food, a study released Wednesday showed.
The study published in Neurology, the journal of the American Academy of Neurology, also showed that eating better could help reduce the brain shrinkage commonly associated with Alzheimer's disease. This approach clearly shows the biological and neurological activity that's associated with actual nutrient levels, both good and bad," said Maret Traber, a principal investigator at the Linus Pauling Institute and study co-author.
Researchers at the institute at Oregon State University conducted the study, one of the first of its kind, along with scientists at the Oregon Health and Science University in Portland.
The study, carried out among 104 people at an average age of 87, specifically measured a wide range of blood nutrient levels instead of basing results on food questionnaires, which are less precise and less reliable.
"The vitamins and nutrients you get from eating a wide range of fruits, vegetables and fish can be measured in blood biomarkers," Traber said.
"I'm a firm believer these nutrients have strong potential to protect your brain and make it work better."
Researchers noted the positive effects of high levels of vitamins B, C, D and E, as well as the healthy oils most commonly found in fish, on mental quickness and brain size.
Those with a higher intake of trans-fats -- commonly found in fried foods, fast foods and other less healthy diet options -- did not perform as well on cognitive tests.
Researchers found that while age and education affected performance on the cognitive tests, nutrient status accounted for 17 percent of the variation in scores, and 37 percent of the differences in brain volume. Of those who took part in the study, seven percent showed a vitamin B12 deficiency, and 25 percent did not have enough vitamin D in their systems.
Scientists tested 30 different nutrient biomarkers. In addition, 42 participants had MRI scans to measure their brain volume.
"These findings are based on average people eating average American diets," Traber said.
"If anyone right now is considering a New Year's resolution to improve their diet, this would certainly give them another reason to eat more fruits and vegetables."
Study co-author Gene Bowman of the Oregon Health and Science University added while results needed to be confirmed, "it is very exciting to think that people could potentially stop their brains from shrinking and keep them sharp by adjusting their diet."
Source-AFP

Mayan Expert Says World Will Not End in 2012..Let's Celebrate New Year 2012

Year 2012 will not mark the end of the world but just be a start of a new calendar, says Mayan timekeeper.
Many consider it a joke although others are scared we might never live to see next year thanks to the Mayan calendar's 'apocalyptic' prediction, the Daily Mail reported.But Mayan expert Leonzo Barreno, of Saskatchewan, Canada, has asserted that the 'apocalypse' concept is a false interpretation of the Long Count calendar.

The University of Regina journalism professor said Mayan elders told him that December 21 this year simply marks the beginning of a new calendar.
Barreno, who immigrated to Canada from Guatemala 23 years ago, was trained by Mayan elders to read the calendars.
"There are two sides to the story," he told CBC News.
"The one that we know is this apocalyptic meaning that has been given to the Long Count."The other side of the story is the Mayan side, which you rarely see on media articles, because they never interview my own people."
He revealed that Mayan people are featured for just five seconds of the film '2012', starring John Cusack, which is somewhat based on their 'predictions'.
"When I grew up during my training I never hear the word "end of the world" from the elders or spiritual leaders." Mr Barreno added.
"For them it's a joyous event, not an apocalyptic event. What is coming is the end of a calendar and the beginning of a new one."
Barreno said that it is 'cyclical'.
"This has happened before. According to the elders it's the fifth time it's happened," he added.
Source-ANI

Red Meat Increases the Risk of Kidney Cancer

People who eat lots of red meat may have a higher risk of kidney cancer, according to researchers from the University of North Texas Health Science Center in Fort Worth.
Researchers found that middle-aged adults who ate the most red meat (about 4 ounces of red meat a day) were 19% more likely to be diagnosed with kidney cancer (renal cell carcinoma i.e. RCC) than those who ate the least (less than 1 ounce a day). Higher intake of chemicals found in grilled or barbecued meat was also linked to increased risk of the disease.
The study is published in the American Journal of Clinical Nutrition.

Famous Cancer Survivor's Miracle Cure Challenged

Cancer experts have challenged the alternative therapies guru Ian Gawler, who claims to have cured himself from secondary cancer. The new medical report has cast doubt that he might not have had the disease and could have been wrongly diagnosed.Dr Gawler, 61, Australia's most famous cancer survivor and founder of the Gawler Foundation, had advanced tuberculosis rather than the secondary bone cancer he was told he had in the late 1970s, says the online report in the Royal Australian College of Physicians' monthly Internal Medicine Journal.
Eminent oncologists Associate Professor Ian Haines of Cabrini Hospital in Melbourne and Professor Ray Lowenthal of Tasmania's Royal Hobart Hospital wrote the report.
Dr Gawler's books on curing cancer without conventional medicine are bestsellers.
His foundation's residential programs have treated more than 15,000 sufferers, many of whom swear by his methods involving strict diets, "mind-training" and meditation. Another 75,000 have attended Gawler Foundation lectures and workshops.
But Dr Gawler, OAM, said it was "ridiculous" to claim his secondary cancer never happened.
"I would question the authors' motivations given my prominence in this field," the Sydney Morning Herald quoted him as saying.
"The nub of the argument is whether inadequate testing was done on me," he added.
Professor Lowenthal has been a long-time critic of Dr Gawler's methods but Associate Professor Haines said he was a "courageous fellow who I know, respect and admire ... But I don't want patients thinking this man cured himself of advanced cancer".
Associate Professor Haines said alternative or "complementary" therapies were fine in conjunction with conventional medicine but should not be the only treatment.
The Internal Medicine Journal report says all Dr Gawler's symptoms between 1975 and 1978 can be scientifically explained by "advanced ... disseminated ... mycobacterial infection" such as TB.
The report states Dr Gawler's disease was "wrongly labelled".
Source-ANI

'Faceless and Brainless' Fish?

A new study has said that a 'faceless and brainless' fish has been recorded in Scotland for the first time. This species can be considered as a modern representative of the first animals that evolved a backbone.The government-backed surveys this year covered around 2,200 square miles and the Scottish government has hailed the finds.
WWF Scotland said the results highlighted the need to better protect the marine environment, the BBC reported.
The organisations that carried out the work, including Scottish Natural Heritage and Edinburgh's Heriot-Watt University, shot underwater video and used acoustic and 3D images for the surveys.
Off the west coast, fan mussels were found. Growing to up to 48cm long, the mussels are Scotland's largest seashells.
Around the Small Isles over 100 specimens of marine life were noted.
Off Tankerness on Orkney, the government said that the prehistoric 'faceless and brainless' amphioxus fish was recorded.
With a nerve chord down its back, the fish does not have a distinctive face or brain.
Other finds included flame shell beds in Loch Linnhe in Argyll and new communities of northern feather star off the Sound of Canna.
Environment Secretary Richard Lochhead regarded the finds as 'weird and wonderful'.
"The waters around Scotland are rich in such fascinating biodiversity and it's our responsibility to protect this fragile environment," he said.
"That's why we have ramped up our marine survey work, with plans being prepared for new surveys in 2012 to further our knowledge of what lies beneath Scotland's seas," he added.
Source-ANI

China Food Safety Scandal Widens to Oil and Peanuts

A cancer-causing toxin in peanuts and cooking oil that was only recently discovered in milk has been detected in oil and peanuts by Chinese authorities.
The food safety regulator in Shenzhen said it had found excessive levels of aflatoxin in peanuts sold in three stores, and in cooking oil in four restaurants, the official Xinhua news agency said late Friday.
Calls to the regulator -- the Shenzhen market supervision bureau -- went unanswered.
The incident comes after leading dairy firm Mengniu revealed at the weekend that authorities found high levels of aflatoxin in a batch of milk before it was sold, caused by cows eating mouldy feed at a farm in southwest China.
Authorities in Guangdong province -- where Shenzhen is located -- then announced they had recalled cooking oil products made by three firms after finding they contained too much aflatoxin.
It was unclear whether the companies made the tainted oil found in the restaurants in Shenzhen.
Aflatoxins, which affect grains and other agricultural products, can increase the risk of cancer, including liver cancer, according to the World Health Organisation.
Chinese state media and netizens have blasted Mengniu as consumers voice anger over yet another food safety scandal to hit the country, despite repeated crackdowns on product safety violations.
Milk was at the centre of one of China's biggest food safety scandals in 2008 when the industrial chemical melamine was found to have been illegally added to dairy products to give the appearance of higher protein content.
At least six babies died and another 300,000 became ill after drinking milk tainted with the chemical.
Mengniu on Monday issued a public apology in an online statement.
Source-AFP