In a session about two of the most promising pharmaceutical markets (for both sales and clinical trials) the 2007 Regulatory Affairs Professionals Society conference had well-travelled speakers to a variety of countries. We happened to hear two presentations that were designed to spare the audience the pain of easy mistakes in those developing markets.

One of them was Pfizer’s head of regulatory policy in Latin America, Anthony Ventura. “I want to give you an idea of who you should be talking to,” he said. International harmonization efforts to align the rules in different countries are coming along, he said, but more likely to affect the lives of his children than the immediate future.

In Latin America, Ventura said, “there are no two registration dossiers alike. The requirements are becoming less and less harmonized and more demanding as we move on.”

Booming Brazil

Brazil is the key nation to watch, Ventura said. “Brazil is very closely tied into the FDA,” Ventura said. “The region follows Brazil as a trendsetter. You can look at Brazil and see the future, where things are heading.”

Brazil’s version of the FDA is called Amvisa. It is a standalone bureaucracy with its own budget.

One focus of the Brazilian agency is a Certificate of Pharmaceutical Product (CPP), which is issued by the FDA for drugs manufactured in the U.S. But past abuses have forced the U.S. to be a bit more strict about issuing the CPP. Only the CDER branch of FDA issues the CPP, he says.

Avoid Arrogance

Timetables for launching a product, of course, will be worked out with commercial and marketing teams. But Ventura says it’s important not to engage the regulatory authorities with too much attitude. “We have to create a partnership with the local agencies,” he says. “You can’t approach them and say ‘this is the way it’s done in Europe and the U.S.’ and that’s it. We make it transparent so that everyone knows what they need to do well in advance.” Education of the rationale for policies north of the equator may help, he suggests.

Ames Gross, president and founder of the Pacific Bridge Medical consultancy, has been going to China for just shy of 20 years. At one time, he said, getting a drug approved required the right personal contacts and what we will euphemistically call “luck.” (Let’s just say luck can take many forms.) Gross noted that the head of the Chinese version of the FDA, the SFDA, was recently executed for lapses on the job. But for prosperous members of the society, the quality of health care in China is changing. One of his friends who once would have returned to the west for a coronary bypass operation recently chose to stay in China for the procedure instead.

Watch Data Quality

The Chinese drug market is $20 billion, less than half the size of Japan’s. Of course, it’s no secret that China has a massive population of treatment-naïve patients with no access to leading western medicines. Dietary and lifestyle changes are now making western diseases more common in China. “You see more cardiovascular disease and cancer where your drugs could help the situation. There could be quite a few patients in your disease category,” says Gross. But Gross says there may be data quality issues.

There is also the issue of a tightening regulatory environment. The Chinese government has issued dozens of technical guidelines over the past two years. No, they’re not in English. There are three categories of products: drugs, biologics, and traditional Chinese therapies. The prices of drugs coming to market in China must be approved by the government, a process that typically takes a month. Employees, for their part, pay for drugs out of pocket and are reimbursed by later. “It’s the government that is the sole payor,” says Gross. “The government has a vested interest in keeping prices down and has introduced multiple price caps.”

A Real Office?

Some caution about choosing a partner is advised, he says. Finding a local contract research organization is a viable strategy. But it may be wise to verify that the company you are hoping to work with is capable of what it’s promising. Says Gross: “All too often I have seen the local clinical trial office, and it was two people in the back of a factory making medical devices. You want to be careful doing clinical trials in China.” Imported drugs must pass quality assurance at one of 18 Chinese port cities to gain entry to the country.

Humility may also be a good strategy in China. The arrogant American may not be as common as in the past, but Gross still sounded a warning. “It’s important to be humble when dealing with the SFDA,” he says, noting that body language matters. “The cultural issues are important,” he says.

d9A2t49mkex