FDA China presence imminent; DIA sets up in India

By Kirsty Barnes

- Last updated on GMT

Related tags Pharmacology

The US Food and Drug Administration (FDA) has revealed it will be
operating on the ground in China imminently, while the Drug
Information Association (DIA) has just planted itself in Asia's
other pharma don, India.

Giving an update on its China plans, Mike Leavitt, secretary of the FDA's Health and Human Services (HHS) advised the media that although the agency's new office in Beijing will be officially opened in October following final approval from the Chinese government, it expects to have staff already operating in the country in May.

Moreover, it has been announced that the new China office will be lead by Christopher Hickey, who will move from his present role as director of the HHS' Asia and Pacific offices.

In total, the agency has been granted approval from the US State Department to establish eight full-time, permanent FDA positions at US diplomatic posts in China over the next 18 months, pending authorisation from the Chinese government.

In addition to this, the watchdog has indicated that it will also be hiring 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.

The move is part of its " Beyond our Borders " initiative, which aims to build stronger cooperative relationships with the FDA's counterpart agencies around the world and enhanced technical cooperation with foreign regulators, as the globalisation trend intensifies.

" The permanent overseas offices in China will also allow greater access for inspections and greater interactions with manufacturers to help assure that products that are shipped to the US meet standards for safety and manufacturing quality ," said Murray Lumpkin, deputy commissioner for International and Special Programs, FDA.

Establishing a presence on the ground in China in particular has become crucial for the agency, as the country has been at the centre of a string of numerous consumer safety breaches of late and has been criticised over its lack of oversight over the quality of the escalating number of food and drug imports reaching US shores, the latest being a health scare involving contaminated lots of heparin.

Meanwhile, the DIA has announced the recent opening of its first office in India, in Mumbai, along with the creation of a Provisional Advisory Council of India (ACI).

The " rapid growth " of India's biopharmaceutical industry, which is predicted to reach $1bn by 2010 up from $100m in 2006, was behind the DIA's decision to establish a presence in the country.

" The statistics are incredible… More than 15 per cent of the world's clinical trials are expected to be conducted in India by 2011 ", said Linda McGoldrick, DIA's worldwide executive director.

" The industry's meteoric rise in this emerging region creates a significant need for DIA's credible international forum that is precedent-setting.

We bring together industry, academia, regulators and patient organisations to provide ongoing training for professionals on regulations, clinical practices and safety standards that will impact the approval of drugs developed in India for the global market. "

The DIA's Indian office is the fourth global location for the association, which also operates from Pennsylvania, US, Basel, Switzerland, and Tokyo, Japan.

In conjunction with the new office, the provisional ACI has been established to assist in the early planning stages of DIA initiatives in India and advise on the region's educational needs for training programs and conferences.

Chaired by Dr Nandkumar K. Chodankar, president of the API Division of Watson Pharmaceuticals, the ACI is comprised of 13 members who represent industry, academia, and government agencies.

Ron Fitzmartin, president of the DIA's Board of Directors said that the agency's " comprehensive outreach " to the Indian marketplace is " a natural one " for DIA. "

The interest in this region is global…So many of our existing North American, European, and Japanese members are looking at India as an important region in drug development ," he said.

" Our presence there means we can help our membership around the globe understand the evolving Indian pharmaceutical landscape while also providing impartial training forums and multidisciplinary perspectives for the growing number of Indian drug development professionals. "

As a first step, the DIA is launching its first annual Indian regulatory conference, to be held next week on April 28-29 in Mumbai, which will address the issues surrounding the quality and safety of clinical trials in the country.

Over the past two years, the agency has already started running conferences on drug discovery and clinical development in India, pertaining to the global development of biopharma products.

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