The following is a summary of important provisions of the draft regulation:

 

1. Article 2 of the draft regulation provides that SFDA shall prioritize the evaluation and approval of innovative new drugs and new drugs indicated for hard-to-treat diseases and diseases severely threatening human life, and at the same time the agency shall strengthen its communications and exchanges with registration applicants of such new drugs during the process of drug development and registration.

 

2. Article 5 of the draft regulation sets out that new drugs falling into the following four categories may apply for drug registration under the special approval procedures.

 

a) Active ingredients extracted from plants and animal or mineral resources that have never been marketed in China and their formulations, and newly found herbal materials and their formulations;

b) Active pharmaceutical ingredients (APIs) and their formulations or biological products which are not yet approved to be marketed in domestic and foreign markets;

c) New drugs showing clear therapeutic advantages in the treatment of AIDS, malignant tumors and rarely seen diseases; and

 

d) New drugs that can be used to treat diseases for which there is no known effective therapy yet available.

 

3. Article 5 and 8 of the draft regulation provides that drug registration applications meeting criteria of the first two categories under Article 5 may submit their applications for special approval procedures in the process of registration, in which case the Center for Drug Evaluation of the SFDA will decide whether to admit the special applications within five days. Those meeting the criteria of the last two categories under Article 5 may submit their applications for special approval procedures when they apply for production approvals, in which case the Center for Drug Evaluation will organize expert panel meetings to decide whether to accept their special applications within 20 days after receipt of them. 

 

4. Article 6 of the draft regulation stipulates that applicants for the special approval procedures should submit summaries of relevant supporting research data together with the application form.

 

5. Article 13 of the draft regulation requires the SFDA Center for Drug Evaluation to establish working mechanisms to communicate and exchange opinions with such new drug applicants including organizing evaluation expert panel meetings.

 

6. Article 14 provides that the SFDA will appraise the applications for clinical trials of such new drug within 80 days (10 days less than the standard procedures), and evaluate the applications for production of such new drugs within 120 days (30 days less than the standard procedures).

 

7. Article 15 of the draft regulation allows registration applicants under special procedures to submit additional information to their applications at and after evaluation expert panel meetings, or when there is newly discovered major safety information. Evaluation time of new drugs under the first two categories of Article 5 will not be extended under such circumstances, while that for new drugs under the third category will also not be extended in principle if they submit such additional information before the Center for Drug Evaluation completes its evaluation. In the cases if they submit such additional information after the Center for Drug Evaluation completes its evaluations, the evaluation time will be extended by no more than 20 days.

 

8. Chapter 5 (Article 17 to 24) of the draft regulation provides the procedures, methods and contents of the communications and exchanges between the Center for Drug Evaluation and applicants subject to the special approval procedures.

 

9. Chapter 6 (Article 25 to 34) of the draft regulation stipulates the requirements for drug products subject to the special approval procedures in the areas of risk control in clinical trials, post-marketing surveillance and adverse drug reactions.

 

10. Chapter 7 (Article 35 and 36) provides the circumstances under which such special approval procedures can be terminated.