The four faster routes to drug approval in China

The Drug Registration Measures provide four faster routes for a drug in China: the breakthrough therapy procedure, conditional approval, priority review and special approval.¹ Only two of them change a review period. Priority review cuts the review of a marketing application from 200 working days to 130, and to 70 for a rare disease drug that is in urgent clinical need and already marketed abroad.¹ Special approval applies in a public health emergency and works in days.²

A reader who knows the FDA programmes will find familiar names with different content. Breakthrough therapy in China gives access to the reviewer during development and gives no right to a shorter review. Conditional approval places a period of validity in the registration certificate itself.¹

Breakthrough therapy

Article 59 opens the procedure during clinical trials. It is available for an innovative drug or an improved new drug that prevents or treats a disease that is seriously life-threatening or seriously affects quality of life.¹ One of two further conditions must be met. Either no effective means of prevention or treatment exists, or there is sufficient evidence of a clear clinical advantage over existing treatment.¹

The applicant applies to the Center for Drug Evaluation, which publishes qualifying products before admitting them.¹ Article 61 gives two forms of support.¹

• The applicant may ask for a meeting with the Center at key stages of the trial, and the Center assigns reviewers to it.
• The applicant may submit research materials in stages. The Center gives its opinion or advice on the next step of the research on the basis of what has been submitted.

The procedure ends where the product no longer meets the conditions, on the applicant’s request or on the Center’s own finding.¹

Conditional approval

Article 63 allows an application for conditional approval during clinical trials in three situations.¹

• The drug treats a seriously life-threatening disease for which no effective treatment exists, and trial data already confirms efficacy and can predict clinical value.
• The drug is urgently needed for public health, and trial data already shows efficacy and can predict clinical value.
• The product is a vaccine urgently needed for a major public health emergency, or another vaccine that the National Health Commission finds to be urgently needed, and the assessed benefit outweighs the risk.

Article 26 of the Drug Administration Law gives the statutory basis for the first two.³

The applicant discusses the conditions and the research still to be completed with the Center for Drug Evaluation before it applies.¹ Where approval is granted, the registration certificate records the period of validity of the conditional approval. It also records the research to be completed after marketing and the time limit for it.¹

The holder must take risk management measures after marketing and complete the required studies in time, filing them as a supplementary application.¹ A holder may miss the time limit or fail to show that benefit outweighs risk. The National Medical Products Administration then deals with the matter under the law, up to cancellation of the registration certificate.¹

Priority review

Article 68 allows an application for priority review with the marketing application, for drugs of clear clinical value in the following groups.¹

• drugs in short supply that are in urgent clinical need
• innovative and improved new drugs for major infectious diseases, rare diseases and similar diseases
• new paediatric products, dosage forms and strengths suited to the physiology of children
• vaccines urgently needed for disease prevention and control, and innovative vaccines
• drugs admitted to the breakthrough therapy procedure
• drugs that meet the conditions for conditional approval

The applicant must discuss the application with the Center for Drug Evaluation before filing, and files the request for priority with the marketing application once the discussion has confirmed it.¹ The Center publishes qualifying products before admitting them.¹

Article 70 sets what priority gives.¹

	Review period
Ordinary marketing application	200 working days
Priority review	130 working days
Priority review of a rare disease drug in urgent clinical need, marketed abroad and unmarketed in China	70 working days

Inspection, testing and approval of the generic name are arranged with priority, and the applicant may submit further technical materials after agreed communication.¹ Periods in the Measures are counted in working days.¹

The review period is a period for technical review alone. Where the applicant has to supplement its materials, the review restarts when the Center has received all of them. The period is then extended by one third, or by one quarter under priority review.¹ The administrative decision follows within 20 working days.¹

Special approval

Article 72 allows the National Medical Products Administration to apply special approval to drugs needed in a public health emergency, when an emergency threatens and after one has occurred.¹ The procedure itself is in an order of 18 November 2005.²

Step	Period
Reply to a request for a feasibility assessment	24 hours
Decision on whether to accept the application	24 hours
Technical review organised after acceptance	within 24 hours
First round of technical review completed	15 days
Technical review after supplementary materials	3 days
Administrative decision after technical review	3 days

The regulator alone accepts applications once the procedure has started.² Where a national standard already exists for the drug and the regulator finds that no clinical trial is needed, the drug may go straight to approval.² The decision to start the procedure rests with the regulator, in the situations that the order lists.²

What none of the routes shortens

Each period above measures review by the regulator. The time taken to generate clinical evidence sits outside all of them. Conditional approval is the route that reaches that time, since it allows approval on data obtained before the confirmatory studies are complete.¹

Questions people also ask

How long is priority review for a drug in China?

The review period under priority review is 130 working days, against 200 working days for an ordinary marketing application.¹ For a rare disease drug in urgent clinical need that is marketed abroad and unmarketed in China, it is 70 working days.¹

Does breakthrough therapy designation shorten the review?

The breakthrough therapy procedure gives meetings at key stages and advice on staged submissions.¹ A drug in the procedure may apply for priority review when it files for marketing.¹

What happens if the studies after a conditional approval are late?

The National Medical Products Administration deals with the holder under the law, up to cancellation of the registration certificate.¹

Must an applicant talk to the reviewer before asking for priority review?

Article 69 requires the applicant to communicate with the Center for Drug Evaluation before filing, and to file the request once that communication has confirmed it.¹

Can a company ask for special approval?

Special approval applies where the National Medical Products Administration decides to use it for drugs needed in a public health emergency.¹

Footnotes

1. Measures for the Administration of Drug Registration (State Administration for Market Regulation Order No. 27), Articles 59 to 72, 87, 96, 100 and 125. https://www.gov.cn/zhengce/zhengceku/2020-04/01/content_5498012.htm ↩ ↩² ↩³ ↩⁴ ↩⁵ ↩⁶ ↩⁷ ↩⁸ ↩⁹ ↩¹⁰ ↩¹¹ ↩¹² ↩¹³ ↩¹⁴ ↩¹⁵ ↩¹⁶ ↩¹⁷ ↩¹⁸ ↩¹⁹ ↩²⁰ ↩²¹ ↩²² ↩²³ ↩²⁴ ↩²⁵ ↩²⁶ ↩²⁷ ↩²⁸ ↩²⁹ ↩³⁰

2. State Food and Drug Administration, Special Approval Procedure for Drugs, Order No. 21 of 18 November 2005, Articles 2 to 18. https://amr.sz.gov.cn/xxgk/zcwj/scjgfg/content/post_12816910.html ↩ ↩² ↩³ ↩⁴ ↩⁵

3. Drug Administration Law of the People’s Republic of China (revised 2019), Article 26. http://www.gd.gov.cn/zwgk/wjk/zcfgk/content/post_2521598.html ↩