The China Food and Drug Administration has issued for public comment four favourable policies encouraging the innovation of drugs and medical devices

China

The China Food and Drug Administration (the “CFDA”) has issued four draft policies encouraging the innovation of drugs and medical devices (the "Policies”). The Policies aim to improve the policy environment for the research and development of new drugs and medical devices in China, and to ensure the availability of such drugs and medical devices for Chinese patient. Each policy focuses on different aspects, including the patent linkage regime, the reform of clinical trials, improving the review and approval process for registration applications and making administrative measures stricter.

The key elements of the policies are summarised below:

  1. The Relevant Policies on Encouraging the Innovation of Drugs and Medical Devices and Accelerating the Review and Approval Process of the Market Registration of New Drugs and Medical Devices (Circular No.52, 2017)

    Drugs and medical devices that are urgently required in clinical use, that are required for the treatment of rare diseases, or which have compulsory licences, could be allowed a shortened review and approval process for registration. This draft policy suggests that a communication regime between the evaluator, the applicants and experts should be established to enable greater efficiency in the examination process. New drugs are encouraged to be included in to the Drug Reimbursement List.

    Click here for details of this policy.
  2. The Relevant Policies on Encouraging the Innovation of Drugs and Medical Devices and Reforming the Administration of Clinical Trials (Circular No. 53, 2017)

    This draft policy suggests that a new recording regime will replace the existing approval regime for clinical trial institutions and also emphasises the administrative measures for ethical issues of clinical trials. Clinical trial data collected overseas that complies with the relevant requirements of Chinese drug and medical device registration may be accepted by the CFDA. For drugs or medical devices that will be registered in China for the first time, clinical trial data to prove there is no racial difference should also be provided.

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  3. The Relevant Policies on Encouraging Innovation and Implementing the Life-Long Management of Drugs and Medical Devices (Circular No.54, 2017)

    This draft policy clarifies the liability position of the Market Authorization Holders (the “MAH”), the Contract Research Organisations, the clinical trial institutions and the entrusted manufacturers and distributors. The current pilot MAH regime is expected to be introduced nationwide. Marketed injections and medical devices may be required to re-evaluate their products' safety, effectiveness and quality controllability. Fraud in clinical trial data and bribery of medical representatives will also be strictly regulated.

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  4. The Innovation of Drugs and Medical Devices and Protecting the Rights of Innovators (Circular No. 55, 2017)

    This draft policy clarifies the Chinese ‘Patent Linkage’ regime which is generally similar to that of the US. The draft policy states that a Chinese Orange Book should be established, updating the current data protection regime to allow for varied scope of protection periods from 1.5 to 10 years. The draft policy also emphasises the confidentiality obligations of national staff in China.

    Click here for details of this policy.

Although the draft policies are not in final form, the drafts are considered to be an indication of the structure of the final policies decided by the CFDA. Undoubtedly, the draft policies indicate significant opportunities and benefits for the whole pharmaceutical industry. In particular, the draft policies address many of the key concerns of multinational companies, such as the long registration process, patent infringement, acceptance of overseas trial data and the implementation of the MAH regime. Multinational companies will greatly benefit if the contents of the drafts become effective.

We are monitoring the progress of the drafts and will provide updates in due course.