Among the major players in the industry, China has long been viewed as a country with huge potential. With a developing economy, an enormous population, and an eager workforce, some say there may never be a better time to conduct trials in the vast country. Nevertheless, despite low costs and a patient naïve population, complex regulations are deterring sponsors from attempting clinical research.

What's more, the differing rules and regulations set forth by the Ministry of Health (MoH), CFDA (China Food and Drug Administration), and CDE (Centre for Drug Evaluation) mean many companies face delays when starting trials because they can't get approvals on time. For companies running trials in China, this can have far-reaching implications.

With China also restructuring its regulatory framework, companies in and outside of the country are finding it difficult to follow new regulations as and when they come into effect. While the natural course of action would be to seek out Chinese vendors familiar with the laws, this has proven an arduous task in itself, according to some experts. Conflicting information given by Chinese vendors on the exact rules and regulations make it difficult to know what the official requirements are.

"CFDA procedures are very unclear and strict, especially for first-in-human products," said one clinical professional. "After you've sent your request, it isn't possible to track your application once it's been submitted."

Last year, the CFDA introduced new regulations that sought to improve approval timelines. Their overarching aim was to expand the fast track approval pathway while changing the classifications for new drugs and generics. What's more, the CFDA put in effect a new clinical trial application (CTA) policy for investigational new drugs (IND) which, according to Wang, has markedly changed from previous guidelines.

"We are now filling out applications according to the new rules and requirements," the professional said. "To overcome any issues that aren't clear, we're engaging more with the CDE, who's in charge of reviewing applications."

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On average, approval timelines for INDs have been reduced to seven months (with approvals for biologics now averaging 12 months). The drive to reform drug development in China is part of a wider effort by the government to encourage drug innovation, improve drug quality, and promote the clinical trial industry. As well as standardizing evaluation and approval procedures, the CFDA recently reformed its chemical drug registration policy, in a bid to make it easier and less time consuming.

"Before, the chemical drug registration used to have six categories to fill up, but it is now only five, which is a lot easier," she said.

As new rules come into effect, what are the keys to navigating Chinese regulations? It goes without saying that approval timelines remain a sticking point. Although timelines are gradually improving, sponsors need to take necessary precautions to safeguard their trial in the event gaining approval takes longer than anticipated. In addition to approval timelines, there are three other factors sponsors must consider:


Provide sufficient quality data

When it comes to submitting your CTA, sponsors need to provide sufficient data. Typically, the CFDA require companies present clinical data (or long-term toxicology data) prior to giving any clinical trial the go-ahead. Failure to demonstrate high quality data could well hinder your application, so its importance cannot be overstated. What's more, sponsors need to be aware of the missteps that lead to a rejected application. According to a recent study by the Centre for Innovation in Regulatory Science (CIRS), six pharma companies had 12 CTAs rejected in the last 18 months. The report pointed to insufficient data and a lack of preclinical animal data as some of the reasons behind the rejected applications. Therefore, it's crucial sponsors ensure they submit high quality data to aid their chances of getting their CTA approved.


Language Barriers

When conducting clinical research in foreign countries, dealing with language barriers is part and parcel of global clinical trials, and it is no different in China. Sponsors must submit the necessary documents to the CFDA in Chinese (Mandarin). Failure to do so could result in potential delays down the line. What's more, make sure your regulatory documents are translated by experienced interpreters. Furthermore, translators, with expertise in rendering documents for the pharma industry, "must follow a well-established process to ensure that translations are accurate and culturally sensitive" (Bairu & Chin). So it is crucial sponsors bring onboard translators who are fluent in both the source language and Chinese.


Partner with Chinese-based vendors

Once you've gained approval to begin your trial, be sure to partner with Chinese-based CROs if you haven't planned on doing so. There are numerous advantages to partnering with local vendors chief among them is their familiarity with Chinese laws and procedures. If it's your first time conducting a trial in China, it's important to bring onboard local vendors that have an established reputation and experience dealing with regulatory bodies. Furthermore, make certain your vendor has expertise in GCP training and practice enforcement, as well as a deep understanding of IND (investigational new drug), NDA (new drug application), and ANDA (abbreviated new drug application) procedures. Ultimately, regardless of whether you're a large or small company, conducting research in China present significant challenges. Sponsors should therefore be prepared to work with the system as well as their professionals.





R Stephen Porter, VDDI Pharmaceuticals, Paradox of Conducting Clinical Trials in—VDDI-Pharmaceuticals.pdf

Nicholas P Zemo, Accelovance, China, Clinical Trial Strategies for Small Pharma

Tom Guntly, FibroGen, Outsourcing Partnerships in China Clinical Trials

Menghis Bairu & Richard Chin, Global Clinical Trials Playbook: Capacity and Capability Building


PHOTO CREDIT: Nicolas Raymond via