On January 7, 2009, the State Food and Drug Administration of the PRC (SFDA) issued the Provisions on Special Approval for the Registration of New Drugs. Through the Provisions, the Chinese government intends to encourage research on and the development of new drugs, while improving its control over related risks. The Provisions make up the third supplementary document that intends to further facilitate the implementation of the Measures for the Administration of Drug Registration promulgated by SFDA on October 10, 2007.
The Provisions lay out the conditions, procedures and requirements for obtaining special approval for the registration of new drugs under the general principles of “early intervention, priority review, multi-channel communication and dynamic data supplement.” The Provisions also set out in detail the rights and obligations of the applicant in the special approval process.
Conditions for Applying for the Special Approval
The Provisions provide that SFDA will give special approval for the following new drugs: (1) Active ingredients that are extracted from plants, animals, minerals or other substances and drug preparations containing such active ingredients, as well as newly discovered ingredients and drug preparations containing those ingredients, that have not been sold in China; (2) Chemical active pharmaceutical ingredients (chemical APIs), as well as drug preparations and biological products containing chemical APIs, that have not obtained the approval to be sold in China and abroad; (3) New drugs that have obvious clinical advantages in treating AIDS, cancer, or rare diseases; and (4) New drugs that treat diseases for which there is no other effective treatment available.
For drugs falling under items 1 or 2 above, an applicant requesting special approval may file an application to do so with SFDA when applying for the drug’s clinical trial approval. The Center for Drug Evaluation (CDE) will confirm eligibility within five working days. For drugs under items 3 or 4, the applicant may request special approval when applying for permission to manufacture the new drug, and CDE will subsequently hold a meeting with experts to confirm eligibility within 20 days.
Key Features of the Special Approval Process
First, the special approval process is specified as an independent channel separate from other applications for the registration of drugs. SFDA will give priority to the registration of new drugs which are eligible for special approval. Second, SFDA has established a communication mechanism through which it can discuss with applicants relevant technical issues before or during applications for the registration of new drugs. Third, SFDA is more flexible with applicants who are eligible for special approval in terms of the supplementary materials they may submit in support of their applications for the registration of new drugs. In addition to providing the supplementary materials requested by CDE, an applicant may also provide new technical materials, including important information on safety, materials requested upon the experts’ meeting, or materials necessary for facilitating communication between the applicant and SFDA.
Risk Control Provisions
In order to minimize risks, the Provisions provide that SFDA may terminate the special approval process in any of the following situations: (1) If the applicant requests the termination; (2) If the applicant fails to timely and duly fulfill its obligations; or (3) If the experts decide in their meeting to terminate the special approval process.
Under the Provisions, the applicant for special approval must include a relevant risk control plan and implementation scheme when applying for the clinical trial and manufacturing approval for the new drug.