On October 20th, CFDA released the new technical requirements for accepting overseas clinical data for comments. This technical requirement is based on the guidelines from Further Reform Registration Reviewing and Approval to Encourage Medical Device/Drug Innovation with the goal to accelerate launching new drugs in China.
Here are the highlights:
1. General Rules.
a. CFDA encourages the development of globally synchronous R&D. The global synchronous clinical trials data which meets the requirements of CFDA clinical trial data registration management can be used for drug registrations in China
b. For overseas clinical trial data for drug registration applications in China, the drug listing license holder shall ensure its authenticity, completeness, accuracy and traceability and accept the supervision and inspection by CFDA
2. Requirements for the Integrity of Oversea Clinical Trial
a. All oversea clinical trials and data should be provided when applicants use overseas clinical trial for CFDA registration. Clinical trials and data should not be provided selectively. Ensuring the integrity of clinical trials and data is the basic requirement for accepting a registration application
b. For synchronous global clinical R&D, applicants should collect all type of overseas clinical trial data into a complete package for drug registration
c. For drugs having overseas early stage clinical trials and subsequently conducted clinical trials in China, drug listing license holders should evaluate the early stage clinical trials and data, if the clinical trials and data are integrated, it can be used in CFDA registration.
d. For drugs that have completed clinical trials overseas but are not listed in any country, applicants should provide a complete package of clinical trial data; if the products are listed in a specific country, applicants should also provide safety, effectiveness update data before being used in CFDA registration
e. For generic drugs that have conducted R&D overseas, if they have complete clinical trials and data, it can be used for CFDA registration
3. Quality Requirements for Accepting Oversea Clinical Trial Data
a. Clinical trial data generation process should meet the relevant requirements of the ICH Clinical Trial Management Practice (GCP) and be consistent with the GCP requirements in China
b. For overseas clinical trial data for drug registration applications in China, the drug listing license holder shall ensure its authenticity, completeness, accuracy and traceability
c. The drug listing license holder should ensure that the overseas clinical trial protocol is reasonable, the clinical trial QMS meets the requirements and all data statistical analysis is accurate and complete.
d. To guarantee the quality of clinical trial data, for drugs that are globally and synchronously developed and conducting clinical trials in China, the drug listing license holder could discuss clinical trial protocol with drug reviewing departments to make sure the protocol meets the requirements of drug registration.
4. Basic Technical Requirements for Accepting Overseas Clinical Trial Data
a. Biopharmaceutics
b. Clinical Pharmacology
c. Effectiveness Data
d. Safety Data
5. Results of Accepting Overseas Clinical Trial Data
a. Accepted
b. Not accepted
c. Partially accepted
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Grace Fu Palma
China Med Device, LLC
MA, U.S.
gpalma@chinameddevice.com978-390-4453
www.chinameddevice.com------------------------------