With patients in China having to wait a minimum of six years to access medications already approved in Western markets, the combination of increasing disease burden and limited access to proven medication has resulted in growing pressure on the Chinese government to reform and improve the country’s healthcare system [1].
In a win for both patients and sponsors, the Chinese Food and Drug Administration (CFDA) announced in October plans to accept data from overseas clinical trials in a bid to speed up the approval of new drugs and medical devices [2]. This change in policy will greatly enhance sponsors’ access to the relatively untapped Chinese healthcare market, predicted as being currently worth nearly US$118 billion [3].
The CFDA has implemented the following key five changes [4]:
1) Inclusion of data from clinical trials undertaken outside China
The CFDA has announced it will now accept data generated from clinical trials undertaken outside China for the approval of new drugs, saying “applicants can directly apply for drug listing registration, called NDA (New Drug Application) after the completion of international multinational drug clinical trials” [5].
Submission conditions include clinical data having to meets CFDA standards and must include data on ethnic differences if the drug or device has never been launched in China [6]. Previously, China had only approved drugs tested on people within CFDA-approved clinical research sites only in China.
In practice, this means sponsors can include data derived from clinical trials outside China in regulatory submissions. It also reduces the need to undertake additional clinical trials in China after receiving approvals in elsewhere [7].
This will significantly reduce costs and clinical trial timelines for imported drug and device developers [4].
2) Streamlining of the clinical trial approval process [4]
The CFDA has reduced timelines by amending three key aspects of the clinical trial approval process:
i. Once the ethics committee from the leading investigation site completes its review of the trial application, no review by other sites involved in the clinical trial are required.
ii. After a clinical trial application is filed, if the CFDA or local representatives fail to raise any issues or reject the application with 60 working days; the application is deemed to be approved and the clinical trial may.
iii. Clinical trial samples can be tested by the sponsor or an entrusted third-party testing lab, rather than having to be tested by a government accredited testing lab.
3) A lifting of restrictions on the involvement of Chinese sites in multicentre Phase I studies
The CFDA has lifted restrictions on the involvement of Chinese sites in multicentre Phase I studies in a bid to increase innovative drug development, competition and private sector investment. [8]
When investigating generic products, sponsors are able to choose their phase I trials sites; but new products still need to be investigated at phase I trial sites previously accredited by the CFDA.
4) The provision of Fast-Track approval for drugs and devices which meet urgent clinical need or rare diseases [4]
i. New drugs and devices in development which meet urgent clinical need in China can be approved for marketing conditions if the data from early or mid-stage trials show promising clinical value. New drugs and devices being developed or financed by national research centres or which feature within national development plans will be given priority review and approval.
ii. New drugs or devices for rare diseases can be approved for marketing in China if they have been approved for marketing in overseas.
5) The implementation of a Market Authorisation Holders (MAH) system [6]
Under the new system, MAHs will be responsible for preclinical research, clinical trials, manufacturing, quality control of raw material, distribution and the reporting of adverse drug reactions. MAHs will be fully responsible for all liabilities with respect to the drug [4]. Medical representatives will be prohibited from sales-related responsibility and will need to be registered with the CFDA.
“Novotech welcomes and looks forward to the implementation of these changes. They will undoubtedly make a significant impact on regulatory and clinical trial timelines in China,” said Novotech CRO Executive Director Dr Yooni Kim said, “But while timelines will be reduced, these changes greatly increase the sponsor’s level of responsibility to provide detailed submissions and deliver an enhanced level of management and transparency across all parts of the drug development and clinical trial process – including all aspects managed by their engaged CRO.”
“Now more than ever, CROs operating in China need to deliver absolute confidence and transparency of clinical trial and project management, logistics and data management to their clients. This why working with a regional CRO who not only understands firsthand China’s changing clinical trial industry; but who is also able to provide a wider breadth of expertise in incorporating past clinical trial data into required regulatory submissions. The balance of these elements could make all the difference to your potential success in China,” said Dr Kim.
Click to read the original CFDA statement in Chinese
With 13 offices in 11 countries throughout in the Asia Pacific, Novotech actively works with each country’s regulatory authorities and trial centres to improve clinical trial approval processes and timelines.
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For more information about the untapped clinical trial benefits available in China, download a free copy of the Frost & Sullivan white papers, ‘Asia: Preferred Destination for Clinical Trials’ or feel free to contact us.
About Novotech - www.novotech-cro.com
Headquartered in Sydney, Novotech is internationally recognised as the leading regional full-service contract research organisation (CRO). With a focus on clinical monitoring, Novotech has been instrumental in the success of hundreds of Phase I - IV clinical trials in the Asia Pacific region. Novotech provides clinical development services across all clinical trial phases and therapeutic areas including: feasibility assessments; ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety services, central lab services, report write-up to ICH requirements, project and vendor management. Novotech’s strong Asia Pacific presence included running clinical trials in all key regional markets. Novotech also has worldwide reach through the company's network of strategic partners.
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Footnotes
[1] Fiercebiotech.com: China may relax trial requirements for new drugs, allowing foreign data: Since 2011-12, China has only approved just over 100 new drugs – about one third of the number approved in other developed countries.
[2] Many of these policy changes were outlined and proposed earlier in the Circulars 52 and 53
[3] Fiercebiotech.com: China may relax trial requirements for new drugs, allowing foreign data
[4] Changes outlined in the CFDA’s October 2017 announcement
[5] Chemical & Engineering News (CEN): China will accept foreign clinical trial data
[6] JDSupra, Cooley LLP: China Issues New Policy for Drug and Medical Device Approvals
[7] Pharmafile: China to accelerate drug approvals with overseas trial data
[8] RAPS.org: CFDA Moves Quickly to Implement Reforms to Clinical Trials, Approval Process
Resources reviewed for this Update:
Chemical & Engineering News (CEN): China will accept foreign clinical trial data
CNBC.com: China to accept overseas trial data in bid to speed up drug approvals
Fiercebiotech.com: China may relax trial requirements for new drugs, allowing foreign data
Lexology; CMS China LLP: Significant reform to encourage the innovation of drugs and medical devices
Lexology, Ropes & Gray LLP: Life sciences; Product regulation and liability in China
Ropes & Gray LLP: China FDA’s Pharmaceutical Regulations Ready for Public Comments
JDSupra, Cooley LLP: China Issues New Policy for Drug and Medical Device Approvals
Pharmafile: China to accelerate drug approvals with overseas trial data
RAPS.org: CFDA Moves Quickly to Implement Reforms to Clinical Trials, Approval Process