Each year, new medicines are launched globally but few are available to Chinese patients, in comparison to those in the US or EU. Drug developers are working to reduce this gap and expand the reach of new molecular entities (NMEs) so that they can improve healthcare to patients in need. Confronting this issue requires navigating the evolving regulatory environment in China and capitalizing on parallel development opportunities in the global market.
Bill Hanlon, PhD, vice president, head of Global Regulatory Affairs, shares some of the latest thoughts and strategies from his recent presentation at our Clinical Seminar in China.
The “dual development” approach in China
“With growing innovation and funding in the Chinese pharmaceutical market, drug developers there are well positioned to meet local patient needs,” said Hanlon. Chinese drug development companies follow the China Food and Drug Administration’s (CFDA) Category 1 pathway to develop a new drug that has not yet been marketed anywhere else in the world.
Yet when looking beyond China, these companies often wait to expand their development, if at all, to the US and EU until after their drug has received CFDA approval. However, there are no restrictions to prevent Chinese companies from developing their drugs in the US and EU if a local agent is employed to assist in the parallel development in and outside of China. Large pharma partners have been the traditional local agent for development in the US and EU, but these partnerships can often take a long time to put into place. Chinese companies and, ultimately, patients suffer due to these delays.
“Drug development–experienced contract research organizations (CROs) can act as the US agent for Chinese companies to develop their products in the US while looking for a partner for late development and commercialization, in a process I like to call ‘dual development,’” explained Hanlon. This levels the playing field for Chinese companies in the global market.
“Local Chinese CMC practices and preclinical studies still need to be conducted in accordance with not only CFDA but also EMA/FDA requirements as well,” he added. “Successful dual development demands careful coordination and planning, early in the process. High quality and confidence in the integrity of the data and drug product are critical for dual development success.”
Opportunities for foreign companies
International drug developers face significant challenges in gaining approval of their treatment in China. “In the past, foreign companies could use data from an international multicenter clinical trial (IMCT) to serve as a so-called surrogate for a local trial,” said Hanlon. However, in March 2015 the CFDA removed this as an option. While China’s participation in an IMCT is still possible, a local phase III study still will be required for foreign companies applying for an import drug license (IDL). This is the only path for foreign companies to bring new medicines to China when they have been approved in another country first. Therefore, foreign companies are faced with three applications and three approvals, with long review times to get their products on the market in China. This process is better known as the “3+3” regulation.
“The regulations are changing quickly and may change again soon,” warned Hanlon. “Bringing a new molecular entity into China often requires a drug development partner who can keep up with these regulatory complexities.”
International clients can work with a CRO like us to conduct the preclinical work at in-country facilities or run an in-country trial. “Data generated in China that is of high quality will not only serve the CFDA,” added Hanlon, “but also can meet the high-quality standards in the EU and US.”
Reducing the drug gap
As the Chinese pharmaceutical industry continues to experience significant growth, it is critical to understand how to work within the complex regulatory environment and achieve successful drug registrations. Whether developing new drugs within China or accelerating the Chinese approval of NMEs developed globally, more drug developers are considering in-country partnerships to leverage both CFDA and international regulatory knowledge, carry out parallel development and confront today’s acute drug gap.