Since 2015, the medical and research industries in China have seen a huge shift with their regulatory processes and framework, which is helping to pave the way for Western biotechnology companies to operate clinical development strategies in China.
China is now more aligned than ever with international standards, especially the United States Food and Drug Administration (USFDA), and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), which they joined as a full regulatory member in 2017.
Some of the improvements made to the regulatory environment, and the Clinical Development Strategies for Western biotech companies in China include:
Western Countries Can Enter Local Market
Biotechnology companies from the Western world can now enter the Chinese market by assigning a local legal entity like a biotech company, a medical research entity or a Contract Research Organisation (CRO). These entities will need to act as a Marketing Authorisation Holder, so they’re able to conduct clinical trials.
Leverage Overseas Data
The regulatory reform in China has streamlined the review process.
Western biotechs can leverage data from other countries which have a fast approval process, like Australia, for drug development in China. They can take advantage of the quick timelines to cut down the clinical development timeline by conducting early-phase trials in other countries and using this clinical data for late-phase trial permission in China.
Leverage Network of Local Biotech Companies, CROs, Research Institutions
Western biotechs can partner with local biotech companies, research institutions and CROs to expedite the effective management of projects and clinical development. Western biotech companies can utilise an integrated network of organisations which can provide access to advanced infrastructure, resources, and large participant populations for clinical development of their drugs.
Partnering with local CROs, biotech companies and research institutions can help overcome any cultural differences, while outsourcing the clinical trial management to the CRO can be a powerful strategy to simplify the development process.
Due to its regulatory reforms, China now offers accelerated approval times and avenues, which can be used to expedite the clinical development of their drugs and commercialisation in China. Streamlined approval is offered through:
- Breakthrough therapy designation (for drugs which treat life-threatening conditions).
- Conditional approval (when there’s proof that a medication is expected to be effective).
- Priority approval
- Special approval (clinical trials that are eligible for special approval)
International biotech companies can file a New Drug Application (NDA) in China by using international clinical trial data.
Why Should International Biotech Companies Run Clinical Trials in China?
The main reasons why biotech companies should take advantage of medical and research industry in China include:
Improved Regulatory Environment
The improved regulatory environment includes a streamlined timeline for regulatory approvals with the regulatory guidelines now being on par with Western regulatory authorities and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Another improvement is that international biotech companies are able to use international data for the Clinical Trial Approval (CTA) scheme and for New Drug Application (NDA) approvals.
Cost and Time Benefits
Operating clinical trials in China can be up to 25-40% cheaper than operating them in Western countries.
China also has a shorter timeline for regulatory approvals
Positive Government Policies
The Chinese government’s interest in the Research and Development industry and in the policies that encourage foreign investment have seen an increase which is reflected in their investment towards establishing biotech parks.
China has also provided a range of incentives and subsidies, including research grants.
With 20% of the world’s population in China (1.4 billion people) and 300,000 active trial investigators, there is no shortage of participants and laboratory professionals for Western biotech companies to utilise.
CROs and local biotech companies are available for partnerships to make it easier to meet global development targets.
Increased Focus On Health
China has proven to be a growing healthcare sector with optimised healthcare services and improved healthcare security.
Challenges Faced by International Biotech Companies
Despite all the regulatory reforms in China, there are still some obstacles facing foreign biotech companies. These include:
Language and Cultural Barriers
The main challenge faced by international biotech companies is undoubtedly the language and cultural barriers, despite the implementation of English-language programs and the increase of internationally trained Chinese scientists.
Trial sponsors also need to understand how trial investigators, CROs and clinical trial centers operate in China.
Requirements with Regulatory Reforms
There are some strict regulatory requirements put in place by Chinese regulators for international drugs (approval from the Human Genetic Resource Administration), and additional time needed for getting an import license which can lead to barriers and delays in getting a Clinical Trial Approval (CTA).
Selecting a Reputable CRO
It can be more difficult for international biotech companies to choose a reputable CRO with a good track record and relevant local experience.
Overall, the regulatory authority scene in China has made huge advancements over the last several years, which has also greatly benefitted the international Research and Development industry, and overseas biotech companies. Although there are a few obstacles that still need to be overcome, more international biotech companies are deciding to carry out clinical trials in China, thanks to the transformation of China’s regulatory processes and framework, and the numerous benefits.