On April 25 this year the China National Drug Administration (CNDA) published a proposed draft on Implementing Measures for Pharmaceutical Trial Data Protection. The measures prevent other drug manufacturers from relying on earlier trial data to receive sales approval without permission from the owner of the earlier trial data. The proposed draft extends the trial data protection term to up to 12 years compared with that of up to 6 years previously. During the protection term, the CNDA will not approve marketing of the same drug[i] from a third party without permission of the owner whose drug gets a trial data exclusivity, except if the third party independently runs a trial and collects trial data.
In contrast to the previous trial data protection measures which applies to drugs with new chemical components, the proposed measures are also applicable to drugs including 1) innovative drugs, 2) innovative biological products for therapy, 3) orphan drugs, 4) pediatric drugs, and 5) generic drugs manufactured by a pharmaceutical company that invalidated relevant patents of original drugs successfully. The trial data refers to non-clinical and clinical experimental data related to drug efficacy other than drug safety, and should meet the following conditions:
- i) submitted with the purpose for getting approval for marketing and is required for drug registration application;
- ii) not published or disclosed prior to applying for drug registration;
iii) self-achieved and not dependent on trial data or published research results of others.
The proposed draft involves in a variety of protection terms for different conditions as shown in Table I below.
|Innovative drugs||Use the clinical trial data or Multi-regional Clinical Trial (MRCT) data carried out in China to apply for marketing domestically or apply for marketing domestically and overseas simultaneously||6 years from the date of approval for marketing in China|
|Innovative biological products for therapy||12 years from the date of approval for marketing in China|
|Innovative drugs||Use the Multi-regional Clinical Trial (MRCT) data carried out in China to apply for marketing domestically after first applying overseas||1 to 5 years from the date of approval for marketing in China (Note: If applying for marketing domestically is 6 years later than that first applying overseas, the CNDA will not provide a protection term.)|
|Innovative biological products for therapy|
|Innovative drugs||Only use the clinical trial data carried out overseas to apply for marketing domestically||1.5 years from the date of approval for marketing in China|
|Innovative biological products for therapy||3 years from the date of approval for marketing in China|
|Innovative drugs||Use the clinical trial data carried out overseas and supplement clinical trial data on Chinese subjects to apply for marketing domestically||3 years from the date of approval for marketing in China|
|Innovative biological products for therapy||6 years from the date of approval for marketing in China|
|Orphan drugs||None||6 years from the date of the first approval of the indication of a newly-recognized disease in China|
|Generic drugs||Invalidate relevant patents of original drugs successfully||No official information yet|
In practice, the Applicant should submit the application for trial data protection at the same time as applying for marketing approval, and explain the requested protection term and reasons for protection. After acceptance by the Receiving Office, the CNDA will publicize the trial data protection application for 30 days. If the application passes examination performed by the CNDA, the trial data protection term will come into force when the corresponding drug gets approved for marketing. The information of drug trial data will be recorded by the CNDA in “Catalog of Marketed Drugs.”
During the protection term, if a third party obtains the trial data independently and applies for approval of the same drug, the CNDA will notify the relevant data protection right owner within 30 days after its receipt of the application. The right owner, if it believes the data was obtained fraudulently, can object to the use of the trial data obtained by the third party within 30 days after receiving the notification. The CNDA will complete the data verification within 90 days after its receipt of the objection, and promptly notify the right owner. If the CNDA determines the trial data is fraudulent, it will not give approval to the third party. If not determined to be fraudulent, the third party can get approval for marketing without being blocked by earlier trial data of the right owner.
Additionally, if a drug with trial data protection is not sold within 1 year of approval for marketing in China, an interested party can apply to the CNDA for revocation. It is expected that the proposed procedure for trial data protection may come into force late this year or early next year.
[i] “the same drug” refers to drugs that contain the same active ingredients and apply to the same indications.