Several blockbuster drugs such as 9-valent HPV vaccine and Pyrotinib Maleate Tablets have recently been fast approved for marketing in China, for which the reasons include the priority review procedure and also the "conditional approval" that contributes a great share. Several new drugs applied for conditional approval of marketing in China are listed below, including imported pharmaceutical products and products independently developed in China, with the indications applied for mainly of malignant tumors and individual rare diseases, to meet China’s requirements on conditional approval.

What is conditional approval of marketing?

Generally, safety and effectiveness of new drugs need proving by clinical trials, approval of marketing applications of most new drugs must be based on the clinical endpoint results of Phase III confirmatory clinical studies, however, for some drugs that treat seriously life-threatening diseases or diseases that lack treatment means, such as tumors and rare diseases, the drug regulator will temporarily approve marketing of the drugs to meet clinical demands based on surrogate markers in Phase II pivotal clinical studies, so as to accelerate the new drug marketing, however, such approval is conditional, namely, enterprises need to continue to complete confirmatory clinical studies to confirm the drug benefits after the drug marketing, and apply for full approval.

The conditional approval, a fast track for accelerating new drug marketing, is not pioneered by China, and a large portion of it may be with reference to the Accelerated Approval established by FDA in 1992, namely, the consent to accelerating approval of drugs for seriously life-threatening diseases based on rational surrogate endpoints or intermediate endpoints. China now supports the conditional approval of clinically imperative pharmaceutical products and rare disease drugs.

Conditional approval is a drug regulatory system that grants approval first and requires verification afterwards, and will be faced with many challenges while bringing some positive early benefits. Challenges include: firstly, the selection of appropriate surrogate markers should be able to accurately predict or reflect clinical efficacy and benefits; secondly, the challenge also includes how to ensure enterprises to complete Phase III confirmatory clinical trials within the specified time limit after the marketing, instead of washing their hands of the matter.

Continue Reading: New drugs that have received conditional approval of marketing in China

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