Regulatory

FDA arrives in China

A significant step toward ensuring the global safety of pharmaceuticals?

FDA will establish eight full-time positions at the US Diplomatic posts in China. The agency has already received approval from the US State Department and is now waiting for final authorization from the Chinese government.

The move is part of the agency's plan to hire and place staff in China during the next 18 months to build stronger cooperative relationships and, ultimately, ensure that products shipped to the US meet safety and manufacturing quality standards. In addition, the agency will hire five local Chinese nationals to work with the new FDA staff at the US Embassy in Beijing and the US Consulates General in Shanghai and Guangzhou.

"In an age when a border is not a barrier, the globalized economy demands nothing less than heightened regulatory interoperability, information exchange and cooperation, especially regarding product quality and enforcement matters," says Murray M. Lumpkin, Deputy Commissioner for International and Special Programs, FDA. "Along with the important Memoranda of Agreement signed with two FDA counterpart Chinese agencies, our efforts to fill permanent FDA positions in China are a significant step toward ensuring access to safe food, drugs and medical devices in the global market."

FDA is building on its capacity outside the US in accordance with its initiative Beyond our Borders, which was announced by FDA earlier in the year with the aim of establishing FDA presence overseas and to expand work with foreign regulators to share information more fully. It is believed that FDA's presence in China will allow greater access for inspections and greater interactions with manufacturers to help ensure the safety of pharmaceutical products.

http://www.fda.gov/

R&D

Key to breast cancer?

New research into breast cancer has identified an important gene that could be the key to better testing for the disease, as well as finding a new treatment. Melissa Brown and Juliet French from the University of Queensland (Australia), together with colleagues at the University of Oxford (UK), have studied the breast cancer gene and found that it exists in a looped formation. "Our studies suggest that BRCA1 looks similar to a bow when the gene is switched off, and that part of this 'bow' disappears when the gene is switched on," says Brown. "Interestingly, the shape of the bow changes in different breast cancer cells, raising the possibility that this gene looping may contribute to the cancer process."

The research has recently been published in the Proceedings of the National Academy of Sciences. According to Brown, the next step will be to identify the specific DNA sequences and DNA binding molecules involved in the BRCA1 looping. She is also hoping to examine the sequences in a larger cohort of breast cancer patients, and the information could lead to improved diagnosis and the identification of new therapeutic targets.

http://www.uq.edu.au/

Regulatory

Ranbaxy's Japanese approval

Japan has given the go-ahead for a product developed independently by a foreign pharmaceutical company outside of Japan for the first time. Approval was granted by the ministry of Health and Labour Welfare (Japan) for Indian-based Ranbaxy Laboratories's generic version of Amlodipine tablets (2.5 mg and 5 mg), which are used to help treat high-blood pressure. It is the first independent product approval received by Ranbaxy in Japan, although the company already has four products available in the Japanese generics market. Malvinder Mohan Singh, CEO and Managing Director, says: "This is a significant milestone in our Japan initiative as it marks the acceptance of our affordable generic medicines in one of the most discerning markets. It also reflects strongly in our long term commitment to Japan."

Amlodipine has an estimated market size of US$2 billion and is currently the largest molecule that has gone off patent in Japan, representing the biggest opportunity so far in the Japanese generic market. The government is encouraging generic substitutions, which is reflected in the growing genericization of medicines by 17% by volume in 2007 to 30% in 2012.

http://www.ranbaxy.com/