In an effort to increase the availability of pharmaceutical treatments in China, the China National Drug Administration has recently released guidelines to allow pharmaceutical drugs that have already undergone clinical trials in other countries to enter the Chinese market without undergoing domestic clinical trials, subject to certain requirements regarding trial data.
On July 10, the China National Drug Administration (CNDA) published its Technical Guidelines for the Acceptance of Overseas Clinical Trial Data for Drugs (the Guidelines). This followed the January 10 release of the CNDA’s similar guidelines regarding the acceptance of such data for the registration of medical devices.
Together, these guidelines open the door for the registration in China of pharmaceutical drugs and medical devices that have already undergone clinical trials in other countries but previously could not be sold on the Chinese market without undergoing domestic clinical trials, allowing faster access to the Chinese market with much lower costs for pharmaceutical companies and medical device manufacturers.
The substance of both sets of guidelines is similar, and both are reflective of the Chinese government’s intention to increase the availability of medical devices and pharmaceutical treatments within China and to spur innovation within the domestic market for these products, as laid out in the Opinions on Deepening Reform of the Review and Approval System to Encourage Innovation in Drugs and Medical Devices, issued by the General Office of the State Council on October 8, 2017. However, there are key provisions of which businesses must be aware in order to ensure that their clinical trial data meets the Guidelines’ requirements.
Below are some of the key features of the Guidelines.
The Guidelines apply to drug registration applications using clinical trial data that is generated entirely overseas, as well as data that is generated as a result of simultaneous research and development (R&D) occurring in China and abroad. The Guidelines also cover fully evaluable bioequivalence data derived from overseas R&D for generic drugs.
To qualify, clinical trial data generated overseas must comply with the Good Clinical Practice (GCP) requirements of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
Data sets must be provided in full in order to qualify. Furthermore, if a drug being submitted for registration has already been marketed abroad, the submission must also contain current safety and effectiveness data in addition to the clinical trial data set.
Applicants must also supplement overseas clinical trial data sets by conducting additional “racial sensitivity analyses,” in order to demonstrate that the drug is safe and effective for the Chinese population. Thus, effectiveness and safety data must confirm the effectiveness and safety of the drugs in general use, but must also confirm that the data results within the Chinese ethnic subgroup are consistent with those of the general sample population. Data that suggests ethnic inconsistencies in effectiveness and safety will be considered “partially acceptable” under the Guidelines, and applicants will be required to work with the Center for Drug Evaluation (CDE) of the CNDA in order to conduct targeted clinical trials to determine whether the data is acceptable.
In addition to the Guidelines, the CNDA issued the Administrative Measures on Confidentiality Obligations in Relation to the Review and Registration of Drugs and Medical Devices on May 24, 2017, for which it subsequently issued detailed implementation rules on May 11, 2018 (collectively, the CNDA Confidentiality Rules). These rules require that the CNDA and its local counterparts prevent the disclosure of any confidential information accessed or received during the review, approval, registration, and onsite inspection of drugs and medical devices. Confidential information primarily includes company trade secret information, including but not limited to data relating to manufacturing processes, key technical data, know-how, and clinical trial data, but also includes the personal data of individuals. To ensure enforceability, the CNDA Confidentiality Rules require that all CNDA personnel sign a nondisclosure agreement, and applicants are entitled to bring legal action against the CNDA itself for the unlawful disclosure of confidential information. While the rules do not explicitly grant a right to third-party individuals to sue the CNDA for the unlawful disclosure of their own personal data, individuals may be able to successfully bring action against the CNDA under the Administrative Procedure Law of the People's Republic of China.
On April 25, the CNDA also published its draft Implementation Measures for Drug Trial Data Protection for public comment, with the purpose of establishing a mechanism to provide postmarket protection for drug trial data. Under the proposed measures, when reviewing an application for the registration of a particular drug, the CNDA may not approve a new drug registration application for the same variety of drug within the prescribed data protection period unless the new application is supported by data independently generated by the new applicant, or unless the new applicant obtains the consent of the original drug trial data protection right holder. These measures have yet to be approved.
If you have any questions or would like more information on the issues discussed in this LawFlash, please contact the author, Todd Liao.