BOGOTA, Colombia – Mexico's health secretary recently issued new regulations regarding sanitary inspection and approval for imported biotech products. It is hoped by regulators and biotech companies that the new rules, which clarify many previously unclear aspects of the biotech market, will enable foreign companies to operate with greater confidence and ease in the Latin American country.

Mexico´s regulation of biotech products has been growing since mid-2007, when it issued the General Law of Health, bringing biotech into the country's legal domain. The Mexican congress is now debating an update of the legal framework for the health sector.

In 2009, Mexico issued rules that only permitted innovative and biosimilar biotech products to be distributed in the country. At that time, the government did not issue regulations to establish the pathways through which foreign-produced biopharmaceuticals could enter the market. It was not until 2011 that the requirements for verifying quality, safety and efficiency in biotech products were established and in 2012 an emergency policy was issued as a temporary measure to set the pharmacovigilance standards for biotech products.

"This has taken a long time, and actually we endured without rules for some time," said César Lara, regulations director for the health sector at PricewaterhouseCoopers in Mexico. "The rules issued earlier were emergency regulations that were valid for six-month periods, so we were in a legal limbo."

Mexican regulators are trumpeting the benefits of the new round of regulations. "With the definition of these new rules, which will be enforced beginning in 60 working days, Mexico will be placed at the forefront in Latin America, with a complete, modern and transparent legal framework for all domestic and international manufacturers of biotech innovators and biosimilars," Mikel Arriola, Mexico's federal commissioner at the Mexican Federal Commission for the Protection against Sanitary Risks (Cofepris), said in a press statement released by the country's health authorities.

"It is essential to have a Mexican official standard on biotech drugs to strengthen the regulatory framework and establish complete, updated and orderly regulatory provisions for approval of these drugs," the Cofepris statement said.

"This new regulation promotes the registration of new biotech drugs without foreclosure of products that are currently marketed in Mexico, and establishes general operating guidelines for the evaluation of technical and scientific information submitted during the application process for new records or extensions," it added.

"The constant scientific and technological advances, as well as experience in pharmaceutical and regulatory policy in international organizations such as the World Health Organization and the EMA has allowed Mexico to advance regulatory aspects necessary for evaluation, approval and control of these drugs," the release continued. "In this respect, the regulatory framework of biotech drugs requires constant revision and updating."

The new rules establish that before applying for registration, all biotech drugs must pass a new molecules test committee and subcommittee for the evaluation of new biotech products, both of which consist of biotech specialists and scientists.

"There is still the need to refine the process of the committee of new molecules and the subcommittee of new molecules, which are the two filters that we have to asses [the products]," said Lara. "The committee has misunderstood the pharma industry and vice versa. When they become clear on how these products must be presented it will be much easier. It is a process; the committees are beginning to review the first molecules and this is a process that I hope will last not more than a year to be polished. Then, there will be exponential growth."

It looks like South Korean biotech companies are some of the first to take the new opportunity to compete in the Mexican market's new, more transparent regulatory environment.

Lara said t South Korean companies are the first ones to start working with molecules whose patents are expiring.

"There´s a partnership between Cofepris and the Mexican Institute of Intellectual Property. Both agencies are connected and are publishing which bio products´ patents are expiring – there´s good coordination," he said.

"The South Koreans, who call their products developed with expired patents 'innovative generics,' are the first ones to develop biosimilars in the country. They are playing a very interesting role," Lara added.

Should South Korean firms succeed in their foray into previously uncharted territory in the Mexican biotech market, don't be surprised to see companies from other countries hurrying to get in early. On the flip side of the coin, if that new activity by foreign firms helps drive further development of biotech in Mexico, it is likely that new regulations will be rolled out to further assist the market in its maturation.