Beijing Beishengyan biological Product’s Sabin Strain Inactivated Polioviurs Vaccine (Sabin IPV), secured approval from the China Food and Drug Administration (CFDA) in August 2017. On September 29th, Sabin IPV was officially on the market, offering one more option for IPV precaution.

With the exception of time for material supplements, the CFDA took only 35 days to process production, registration and application of Beishengyan’s IPV and issue a drug approval number and certificate.

Ddu, the leading global pharmaceutical & medical device B2B online platform, learned that it usually takes 150 days to complete all the processes. This begs the question: how did Beishengyan do it within 35 days?

It turns out that the “special review and approval procedure” did it a favor!

The special review and approval procedure for drug registration refers to the procedure and requirements of the State Food and Drug Administration to carry out special review and approval of drugs for handling public heath emergencies under the principle of unified leadership, early involvement, expeditiousness and efficiency, and scientific review and approval, in an effort to approve drugs for the prevention and treatment of public health emergencies as soon as possible under the threat or after the occurrence of public heath emergencies.

So what are the requirements of the special review and approval procedure?

1. What types of drugs fall under the special approval category?

A. According to Decree no. 17 of the China Food and Drug Administration, the following drugs are entitled to the special review and approval procedure.

 The State Food and Drug Administration may, according to law, decide to follow the Procedure to conduct special review and approval of drugs for public health emergencies in any of the following circumstances:

(1) Where the President of the People’s Republic of China declares a state of emergency or the State Council decides that certain areas within a province, autonomous region or municipality directly under the Central Government are in a state of emergency;

(2) Where the contingency program for public health emergencies is initiated according to law;

(3) Where the drug reserve department or the health administrative department of the State Council proposes a special review and approval for drugs having existing national drug standard;

(4) Other circumstances applicable to special review and approval.

B. According to Decree no. 17 of the China Food and Drug Administration, the State Food and Drug Administration is responsible for the review and approval of clinical trials, production and importation of drugs for the prevention and treatment of public health emergencies.

The (food and) drug regulatory department of a province, autonomous region, or municipality directly under the Central Government shall, upon entrustment of the State Food and Drug Administration, be responsible for on-site inspection and sampling of the pilot products of the drugs for the prevention and treatment of public health emergencies.

Beishengyan’s Sabin IPV happened to meet all the requirement of drugs for the prevention and treatment of public health emergencies.

2. What are the processes of the special review and approval procedure?

1) Submission of application

Drugs which fall under categories 1 and 2 must apply for the special review and approval procedure when they apply for clinical trials.

Drugs which fall under categories 3 and 4 must apply for the special review and approval procedure during the same time period as applying for production.

2) Summit documents

Both the Special Review and Approval Procedure form and other relevant documents should be submitted to the department of drug registration. After this has been done, the documents must be submitted to the center of drug approval at the CFDA.

3. Time of review

Special review and approval procedure for categories 1 and 2 should be done within 5 days, and categories 3 and 4 within 20days. 

4. Supplementary documentation

The CFDA will assign an expert group to evaluate and review the registration application and, if supplementary documents are needed, applicants must submit the documents as required within 20 days.

5. Communication

If problems concerning safety or clinical trials schemes are encountered during the process, applicants can summit the Special Review and Approval Procedure Communication form and relevant documents for further discussion.

6. Issuing of certificates

Where the State Food and Drug Administration decides to approve the drug, it shall issue the Letter of Approval for Drug Registration, and may grant an approval number for the drug at the same time if the applicant has appropriate manufacturing conditions; if it decides to disapprove the manufacturing, it shall issue a Disapproval Notice with reasons.

In the event that your company has drugs that meet the requirements above, act right now and hope you can also get them registered within only 35 days!

For more information, please visit http://cn.media.drugdu.com/