China’s Food & Drug Administration has disclosed draft rules that could significantly simplify the process that foreign drug manufacturers must go through to register their products. At present, new drugs are often launched in China years after they are available in other countries.
China is the world’s second-largest drug market but one where foreign firms have struggled with regulations on new products, according to the U.S. International Trade Administration. Worth $108 billion in 2015, the Chinese pharmaceutical market will grow to $167 billion by 2020, the agency expects.
Outlined in a document less than one-page long, the proposed reform notably discusses doing away with a requirement for foreign firms to delay their clinical trials in China until after they have initiated Phase II clinical trials of the drug’s effectiveness in another country.
In addition, foreign manufacturers would not have to undertake country-specific clinical trials in China, as long as China is one of the countries in which patient trials are conducted. Currently, foreign drug firms must conduct special tests of their new drugs on Chinese patients, even when the drugs are already approved in other major markets.
“This is one more step–albeit a critical one—in a clear process designed to bring more innovative drugs to Chinese patients faster and at affordable prices,” comments George Baeder, a former pharmaceutical industry executive who is now a director of China Global Insight, a California-based think tank.
But implementing the proposed reform may pose challenges for China. CFDA has few reviewers who are experienced with innovative drugs, Baeder says. Most agency reviewers, he says, are more familiar with applications for generic drug approval, a far simpler task.
Moreover, reviewers are risk-averse because they are held personally liable when something goes wrong, Baeder adds. “It’s not the review process that gets blamed, it’s the reviewer,” he says. CFDA will need to remove this element of personal risk to speed up approvals, Baeder expects.