Regulators Adapt to Increasingly Globalised Pharmaceutical Industry



Pharma IQ
12/22/2010

Emerging markets are expected to be responsible for much of the growth within the pharmaceutical industry in the coming years.

IMS health predicts the markets it describes as pharmerging will grow at a rate between 15 and 17 percent in 2011, with the vast opening market of China leading the way.

China alone is predicted to see growth of 25 to 27 percent and by the end of the year is expected to be worth $50 billion (£32 billion), making it the third largest pharmaceutical industry in the world. 

Lower costs and huge patient pools form part of the draw of these markets, particularly at a time when the United States Food and Drugs Administration (FDA) is coming under fire for the financial burden its strict regulatory procedures are placing on drug developers.

Emerging markets have typically had less developed regulatory systems, but this is beginning to change as regulators adapt to an increasingly globalised pharmaceutical industry.

Speaking at the 14th International Conference of Drug Regulatory Authorities recently, Singapore minister for health, Khaw Boon Wan, highlighted:  "As the capacity of drug regulators in different countries can vary due to resource constraints, it can only be beneficial for our patients if drug regulators work closely together to share information."

Pharmaceutical companies must learn to adapt to these changing regulatory environments to fully take advantage of the significant opportunities presented by emerging markets.

Clinical trials in emerging markets

While the majority of clinical trials are still conducted in the United States under the purview of the FDA, increasing numbers are moving abroad. According to Clinicaltrials.gov, 23 percent of clinical trials are now held Latin America, Africa and Asia – and it is the latter where huge growth is expected to take place.

According to research published last year in the New England Journal of Medicine (NEJM), there are clear incentives for this, many of these relating to regulatory approval.

For example, the researchers stated: "Clinical testing in developing countries is also attractive to pharmaceutical and device companies because it can help them overcome regulatory barriers for drug approval in these countries in which the population size alone offers the promise of expanding markets."

However, the experts also raised concerns that proper regulation of the clinical trials was not taking place and if due consideration was given to how the results from a clinical trial conducted on residents of developing countries transfer to wealthier nations where the drugs will be sold.

"Regulatory bodies are often structured to monitor the quality of clinical trial data and the safety of drugs and devices in their domestic markets. They have limited information on many aspects of research conducted outside their jurisdictions or countries," the research highlighted.

Working towards a standardisation of standards across developed and emerging markets was said to form part of the answer to this.

FDA steps to regulate emerging markets

The research in the NEJM highlighted that since 2002 the number of FDA regulators outside the United States had increased by 15 percent, while those within the country's borders had decreased.

Steps taken by the regulator recently suggest it is looking to increase its overseas presence in emerging markets even further.

In August the United States Department of Health and Human Services opened three new FDA offices in Beijing, Guangzhou and Shangai, which the regulator said will allow it to work more closely with manufacturers in the country.

Eight FDA senior FDA officials, with experience with both drugs and medical devices, are to be stationed in China.

FDA commissioner Andrew von Eschenbach, MD, said: "A permanent FDA presence in China will help us address the challenges presented by globalisation."

Speaking at the Xavier University's Med-XU earlier this year, FDA officials also said they would be looking to tighten regulations for pharmaceutical companies that outsource manufacturing to emerging markets to enhance the safety of products.

Currently companies are not required to carry out a hands-on inspection of a contractor's facilities, but merely review data on quality controls and product testing.

The proposed changes from the FDA would require companies to personally audit their contractor's operations, potentially increasing the cost of operating within traditionally cheaper emerging markets.