For a long time, it generally takes 3-5 years or even longer for new drugs of transnational companies from being approved to be marketed overseas to being marketed in China. For example, the Avastin targeting metastatic colorectal cancer was already marketed in the U.S. in February 2004, but was not approved to be marketed in China until February 2010; for another example, Afatinib targeting metastatic non-small cell lung cancer that was just approved in China in February this year has already been approved to be marketed in the U.S. early in July 2013.

Then what are the reasons for the lag of marketing of imported pharmaceutical products in China?

Firstly, Measures for the Administration of Drug Registration expressly specifies that imported pharmaceutical products must be approved to go to market in foreign countries before they can be conducted import registration applications in China; secondly, foreign new drugs must be re-conducted clinical trials when they are applied for import in China, the drug clinical trials (including bioequivalence tests) must be approved by CFDA, the time of queuing for approval needs 1-2 years, and the clinical trial time needs 2-3 years, resulting in the overall time to be 3-5 years; thirdly, China requires drugs which are conducted international multi-center drug clinical trials in China to have been registered overseas or entered Phase II or III clinical trials, to protect the broad Chinese patients from becoming the "laboratory rat" of foreign clinical trials; fourthly, generally, foreign new drugs have strict patent protections, and if the original drug enterprises do not apply for import, it will be very difficult for Chinese enterprises to conduct imitation and marketing during the patent periods.

The Decision on Adjusting Issues concerning the Administration of Imported Drug Registration (Draft for Comment) (hereinafter referred to "Draft for Comment") issued by CFDA on March 17 expressly points out that the requirement that drugs which are conducted international multi-center drug clinical trials in China (excluding vaccines) are required to have been registered overseas or entered Phase II or III clinical trials is cancelled; for drugs which are conducted international multi-center drug clinical trials in China, the applications for pharmaceutical product marketing registration can be directly filed upon completion of the international multi-center drug clinical trials; and for new chemical drugs as well as innovative biological drugs for treatment that are applied for import, the requirement that marketing authorizations of the manufacturing countries or regions where overseas pharmaceutical manufacturers are located shall be obtained is cancelled.

The implementation of the Draft for Comment can be said to be big relaxation for imported pharmaceutical product applications, and aims to encourage transnational enterprises to conduct international multi-center clinical trials in China to have Chinese patients get the chances to participate in clinical trials of foreign innovative drugs and greatly shorten the postponing of import and marketing caused by clinical trial lag; it also simplifies the marketing application process of imported new drugs, permits the applications for marketing directly upon the international multi-center clinical trial data without repetition of clinical trials, to accelerate the marketing registration of foreign new drugs in China. Next, foreign new drugs are hopefully to be marketed synchronously in China and foreign countries, or even earlier than foreign markets, to benefit Chinese patients.

But this Draft for Comment will also compress the space of the present me-too new drugs in China to choose the easy way out. Generally, after marketing of foreign new drugs especially blockbuster drugs, many Chinese enterprises would hope to possess the same products to get a "slice of the cake", but due to the patent protection, R&D of relevant pharmaceutical enterprises would use the existing prototype new drugs as the lead compound to conduct structural modification to find the off-patent similar structures, which does not only effectively avoid the patent protection but also obtain new drugs with the same action targets or mechanisms of action, leading to the emergence of the Me-too drugs. As a balance of the innovative drugs and generic drugs, Me-too drugs possess existing biological models and known targets, and have characteristics like low investment, high success rate, low risk, and short R&D cycle. The acceleration of marketing of foreign new drugs in China will put me-too new drugs under certain pressure after marketing. It seems that me-too drugs would lose market value if they have no new highlight under circumstances that the original products of the same kind have been imported for many years and accounted for significant market shares in China, and doctors use them with facility and have been very familiar with the use methods, adverse reactions, dose control and clinical efficacy, etc., and patients recognize the therapeutic actions of them.

Attached:

China Food and Drug Administration

Decision on Adjusting Issues concerning the Administration of Imported Drug Registration

 (Draft for Comment)

In accordance with requirements of Opinions of the State Council on the Reform of Review and Approval System for Drugs and Medical Devices (GF [2015] No. 44), as determined upon study at the executive meeting of the China Food and Drug Administration, the issues concerning the administration of imported drug registration are made the following adjustments in order to encourage the synchronous conduct of clinical trials inside and outside China of new drugs not marketed overseas upon approval, shorten the time lag of marketing time in China and overseas, and meet the public’s clinical demands for new drugs:

I. For drugs which are conducted international multi-center drug clinical trials in China, the requirement that the clinical trial drugs are required to have been registered overseas or entered Phase II or III clinical trials is cancelled, with the exception of vaccine drugs.

II. For drugs which are conducted international multi-center drug clinical trials in China, the applications for pharmaceutical product marketing registration can be directly filed upon completion of the international multi-center drug clinical trials; and during such filing, requirements of Measures for the Administration of Drug Registration and relevant documents shall be performed.

III. For new chemical drugs as well as innovative biological drugs for treatment that are applied for import, the requirement that marketing authorizations of the manufacturing countries or regions where overseas pharmaceutical manufacturers are located shall be obtained is cancelled.

IV. For the registration applications that have been accepted before issuance of this Decision and propose the exemption of import clinical trials based on the international multi-center clinical trial data, if they meet the requirements, the relevant import may be approved.

This Decision is implemented from MM/DD/YY. In the case of any inconsistency between content of relevant pharmaceutical product regulation rules on imported drug registration administration and this Decision, this Decision shall prevail.