BEIJING - China's fast-track review process for certain classes of new drugs, unveiled earlier this month, marks an advance in the country's budding support for innovative medicines, but also might be open only to domestically made products, according to Chinese and American lawyers.

After initially drafting a more liberal set of measures, China's State FDA ultimately issued a conservative version of its Rule on Special Approval for the Registration of New Drugs.

"Under this rule, innovative new drugs and drugs for the treatment of rare and life-threatening diseases are eligible for special approval, which may considerably accelerate the review process," said Yang Chen, who leads the life sciences practice in China for international law firm Sidley Austin.

This accelerated review is potentially available for a range of new pharmaceuticals and active pharmaceutical ingredients, including:

New drugs that have demonstrated clinical advantages in treating AIDS, cancer or rare diseases;

New drugs to treat diseases for which no other effective treatment is available;

Bulk pharmaceutical chemicals that have not obtained marketing approval in China or abroad; and

Active pharmaceutical ingredients derived from plants, animals, minerals or other materials and have not been marketed in China, and drug preparations containing these APIs.

The greatest advantage offered by the new review process is that "there is no more waiting in a long queue for SFDA approval of a new drug," said Yang.

Providing priority reviews for innovative drugs in the treatment of diseases that are among the leading causes of death is also part of SFDA's ongoing effort to upgrade its overall regulation of the pharmaceutical sector (Also see "China Government Report On Drug Regulation Seeks To Increase Transparency" - Scrip, 21 July, 2008.).

The new rule also provides for increased communcations during the review process with officials from SFDA's Center for Drug Evaluation, along with more flexibility in submitting supplementary materials or changing trial protocols, Yang said.

The accelerated review scheme "marks another step toward government support for the development of innovative drugs in China," she said.

The crafting of these special regulatory provisions for new drugs also reflects SFDA's increasing sophistication in handling unique pharmaceutical inventions, according to some industry analysts.

Yet the greatest drawback in the new SFDA regulation is the cloud of uncertainty hanging over, including whether it will be equally applicable to both domestic and foreign drug makers.

"How the rule will be implemented remains to be seen, particularly with respect to imported drugs," said Yang.

The language of the regulation is ambiguous on this point, she added.

On one hand, the regulation "does not explicitly exclude imported drugs from the special approval scheme," said Yang.

But on the other hand, SFDA states in one section of the rule that a request for the fast-track approval process can be made in tandem with an application for a production permit. "These production permits are only applicable to drug manufacturing sites inside China," Yang explained.

On the face of it, "this rule does not appear to be designed for imported drugs," she added.

Scott Bass, who heads the global life sciences team at Sidley Austin's office in Washington, D.C., said that SFDA's new drug regulation "is a key step in the right direction."

"But no final decision appears to have been made with respect to the treatment of foreign drugs," he added.

- Kevin Holden (pharmasia@elsevier.com)

Beijing’s New Fast-track Review For Innovative Medicines Might Be Open Only To Made-in-China Drugs

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