CHINA has issued a draft rule that would speed up the approval process for pharmaceuticals, promising patients faster access to new, advanced drugs for cancer, cardiovascular and other diseases.

The China Food and Drug Administration is soliciting public comment on the draft through April 20.

Of primary interest is a stipulation that foreign drugs will no longer have to win approval overseas or have undergone second-and third-phase clinical trials abroad before they can be tested in China.

Under current rules, new drugs of multinational pharma companies typically wait years to be introduced in the domestic market.

China Food and Drug Administration Director Bi Jingquan told an interviewer earlier this month that his agency is working with relevant authorities to eliminate unreasonable regulations and tackle the backlog of new drug applications.

The Chinese market, he said, poses great opportunities for multinational drug companies.

German-based Boehringer Ingelheim said in an email statement to Shanghai Daily that under the current system, it generally takes up to five years to get a new drug approved in China, even after it has been given the green light overseas. What’s encouraging, the process has seen a clear acceleration since 2015 when China started a series of reforms to clear the accumulated backlog in approval for both Clinical Trial Approval and New Drug Approval. 

“If the draft rule is enacted, Chinese physicians and research organizations are foreseen to have increased opportunities to participate in early phase international clinical trials for innovative drugs，”said the statement.“Local R&D will in turn be benefited from Chinese physicians’ improved knowledge, experience and skills on clinical trial design and management as well as gradually advanced clinical research infrastructure. The accelerated launch of imported new drugs may also stimulate domestic R&D progression to have more genuinely innovative breakthroughs.”

Boehringer Ingelheim said it has actively integrated China into its global clinical development program to better suit for the unmet medical needs. “We will be more active in involving China into early phase development and consider China’s registration requirement as earlier as possible while we design and execute clinical development for our rich pipelines，”it said.

China is expected to overtake the US as the largest pharmaceutical market by 2020, accounting for 7.5 percent of global sales, according to the consulting company IMS Health.

“Multinational drug companies will definitely benefit from the new rules, and they could take China into account much earlier in the drug research and development process,” said Dai Jialing, founder and managing editor at online portal YanFaKe, which tracks the pharmaceutical industry. “Chinese patients will also benefit.”

However, speeding up the approval process is only one step in bringing China up to international standards.

“Innovative drugs still have many challenges to overcome on the home front, such as reimbursement levels and price pressures,” said Dai.

More clinical trials in China could help the nation catch up with Asian neighbors like South Korea, he added. Early stage clinical trials mean moving laboratory work to human studies, and that is a crucial step in drug development.

It also means more demanding work for research labs that conduct research and development on behalf of drug companies.

Had the new rules been put into effect, the accelerated launch of imported new drugs will also stimulate the R&D progress of local drugs, according to Boehringer Ingelheim China.

“We will be more active in involving China in the early phases of development activity and consider China’s drug registration requirements as early as possible,” said the Boehringer Ingelheim statement.

Xu Jia, a consulting partner for pharma at consultants PwC, said the mechanisms for trialing new drugs will need to be enhanced in China in the long term.

But in the short term, investment by Chinese companies in drug research and development will be restrained because of high costs and risks, said Zhao Bing, director and health care industry analyst at UBS Securities.

Tufts Center for the Study of Drug Development in the US estimated last year that the cost of developing a new drug averages at about US$2.87 billion.

“Multinational drug companies will now have more motivation to carry out clinical trials in China, where there are plenty of eligible people for testing and costs are lower,” he said. “But at the end of the day, each company has to balance the upfront cost of new drug discoveries and development against potential sales income.”

To benefit in the long run

Zhao said it could take quite a while for innovative drug sales in China to make a significant contribution to the bottom lines of multinational drug companies because new medicines are usually more expensive and may not be quickly embraced by doctors and patients as soon as they are available on the domestic market.

The China Food and Drug Administration has been in reform mode since August 2015, when it ruled that certain types of new drugs in great demand or urgent situations could be put on a fast-track evaluation channel. The administration said China is likely to become a country where multinational drug companies launch new medicines.

It’s all a game of catch-up, with regulators trying to adapt to an ever-changing landscape in the global drug industry. Even after the China Food and Drug Administration increased the number of specialists at its Center for Drug Evaluation to about 600 from 120 in the past two years, that number is still lags behind the staff of 5,000 at the equivalent agency in the US.

It was somewhat of an embarrassment when GlaxoSmithKline pulled its HPV vaccine Cervarix from the US market just months after winning approval for the drug in China in August last year, citing very low market demand.

Meanwhile, global pharmaceutical giants remain key players in China’s development.

Novartis, which last year opened a US$1 billion Shanghai research and development center that will focus on diseases prevalent in China and Asia, is calling for more collaboration between healthcare authorities and pharma companies, and for the introduction of outside experts in evaluation of new drugs.

Chief Executive Joe Jimenez told the China Development Forum in Beijing in early March that more drug innovation would be achieved through more cross-border and private-public sector collaboration. He said the expediting of China’s drug approval process would, in turn, enhance the research and development environment for drugs.

Roche’s vemurafenib tablets received the CFDA’s approval for the treatment of people with unresectable or metastatic melanoma in China earlier this month. Roche said in an email briefing that the draft rule is a signal of the government’s positive moves to accelerate new drug approvals.

"We believe this would encourage innovative drug to conduct clinical trial simultaneously with the world. At present, Roche is able to conduct phase III trials in China simultaneously with global markets, and we expect to see earlier approvals of our 'new-to-China ' products (products already launched in US, Japan and Europe) that benefit more Chinese patients,” it added.

AstraZeneca’s lung cancer drug Tagrisso also received CFDA’s market approval on March 22, with the launch gap reducing to 16 months while the drug evaluation process also shortened to seven months, showing the drug regulatory agency’s determination in speeding up introduction of new drugs.

Over the years, China has been calling for the scrapping of mark-up on drug sales from hospitals and to encourage hospitals to shift emphasis back to their core function as healthcare service providers.

At the same time, health authorities have taken a hard stance against malpractice in the purchase and sale of drugs. UK-based pharma giant GSK was fined 3 billion yuan in 2014 for bribing doctors and hospitals to prescribe its medicines.