The State Food and Drug Administration ("SFDA") has been for long experiencing a shortage of manpower to efficiently deal with drug applications in a timely manner. This has resulted in long term delays and has become a big annoyance among drug applicants. It usually happens that after half a year or one year of submission of a drug application, the officials then begin to process such application. In addition to the current drug approving regime for drug applications ("Normal Application"), the SFDA issued on 7 January 2009 the Measures on Special Approval of New Drugs ("Measures") to create a "Fast Track" for certain new drug applications ("Fast Track Application").
The Fast Track essentially means priority for reviewing the accepted application, arranging the on-site inspection, testing and evaluation.
Article 7 of the Measures stipulates that the local drug administrations, testing institutions and centre for drug evaluation ("CDE") shall arrange the on-site inspection, testing and evaluation for Fast Track Application on a priority basis over Normal Application.
Although there is no definite shortened time frame provided by the Measures, the priority for reviewing the submitted application, arrangement of on-site inspection, testing and evaluation is expected to shorten the time-consuming waiting time and expedite the whole approval procedures. However, it is noted that under the Normal Application, the waiting period may last for a couple of months to one year and the approval procedures may take approximately two years.
According to Article 2 of the Measures, to be qualified as a Fast Track Application, the application shall be submitted for any of the following new drugs:
- effective components extracted from plants, animals, minerals and other materials that have not been marketed in the PRC and preparations of the same; newly discovered drug materials and preparations thereof
- chemical drugs as well as their active pharmaceutical ingredients ("APIs"); and biological products that have not yet been approved for marketing in the PRC or abroad
- new drugs that are used for the treatment of AIDS, malignant tumors and rare diseases and any other new drugs with an unparalleled advantage in clinical treatment
- drugs treating diseases that as yet have no cure
The applicant needs to make a separate request to the SFDA for
applying the Fast Track scheme. In addition, the applicant shall
meanwhile formulate and submit a risk control plan and a relevant
implementation plan to prevent any potential risk likely arising
out of the clinical trial or when
marketing such drug. The SFDA shall then decide whether or not to accept such application as a Fast Track Application.
Other preferential treatments
The Measures also grant two additional preferential treatments to Fast Track Applications: i) special communication channel; and ii) dynamic data supplement.
Special communication channel
An applicant may apply for pre-communication with the CDE regarding its eligibility for filing of a Fast Track Application and any important technical issues in the first place, and multi-channel communications with the CDE regarding crucial security issues, clinical trial plan or amendment, major alteration of indication or specification of the new drug during the process of clinical trials.
This special communication channel gives the applicant an opportunity to discuss technical issues with the evaluation panel of the CDE and work out solutions to the concerns raised by the CDE. In contrast, applicants under Normal Applications do not have any channel to effectively communicate with the CDE and can do nothing but wait for the final decision of the CDE.
Dynamic data supplement
The applicant is allowed to submit supplementary technical data to the CDE under the following circumstances: i) in the event of new discovery of crucial security information; ii) if so required by the technical evaluation panel or for communication to the CDE; iii) upon receipt of a CDE's notice to supplement data; or iv) in the event of any alteration of the clinical trials.
Under the Normal Application procedure, the applicant shall submit all technical data in the first place and are not allowed to supplement any technical data after the application is submitted unless otherwise required by the SFDA or the CDE. If such applicant does want to supplement, it shall withdraw the original application and file a separate application.
The Measures are aimed at encouraging innovation by streamlining the approving process for desired new drugs and aim to serve as a positive regulatory change favourable for research-based companies.
However, it should be noted that the Measures are not applicable to imported drugs since new drug applications can only be made by domestic applicants (including foreign invested companies). Therefore for foreign pharmaceutical companies, the Measures bring a risk that domestic companies' me-too products could be marketed in China faster than the original products.
This article was written for Law-Now, CMS Cameron McKenna's free online information service. To register for Law-Now, please go to www.law-now.com/law-now/mondaq
Law-Now information is for general purposes and guidance only. The information and opinions expressed in all Law-Now articles are not necessarily comprehensive and do not purport to give professional or legal advice. All Law-Now information relates to circumstances prevailing at the date of its original publication and may not have been updated to reflect subsequent developments.
The original publication date for this article was 06/05/2009.