China FDA Adjusts Registration Requirements for Imported Drugs

China-FDA

11 October 2017 update

The contents below were approved by CFDA on 20th June 2017. Somehow, it was only published today, under the title of No. 35 CFDA Decree. There are just minor revisions compared to the original statements.

  1. Except for biological products for preventive use, for INDs aiming to undergo international multi-centre clinical trials in China, a Phase I trial can be carried out concurrently with other countries. It is no longer required that INDs have already been registered overseas or have already entered Phase II or Phase III trials overseas.

  2. For international multi-centre clinical trials conducted in China, after the completion of such trials, sponsors are eligible to apply for New Drug Applications (NDA) directly.

  3. For imported new chemical drugs and innovative biological products for therapeutic use which are for Clinical Trial Applications (CTA) or NDA, it is no longer a prerequisite that such drugs have received marketing approvals from the countries or territories in which the drug manufacturers reside.

  4. For imported drugs applying for clinical trial registration waivers that were under review by CFDA before the publication of this decree, if the exemptions are based on international multi-centre clinical trials data, import permits can be granted as long as they meet relevant requirements.

Source in Chinese:

《关于调整进口药品注册管理有关事项的决定》政策解读


Original post

On 17 March 2017, China Food and Drug Administration (FDA) announced on its official website a new draft regulation on registration of imported drugs. The draft is currently inviting public comments. Insiders believe that after implementation, this regulation will bring about far-reaching and profound effects for China pharmaceutical market. Below is the main content translated into English.

CFDA

A Decision to Adjust Regulations on Registration of Imported Drugs

(Draft for Public Comments)

To encourage the conduct of concurrent clinical trials of Investigational New Drugs (INDs) manufactured overseas which have not been marketed anywhere in the world, shorten time-to-market between China and overseas, as well as to satisfy the public’s clinical needs for new drugs, CFDA has adjusted its registration requirements on imported drugs as below.

1. Except for vaccines, for drugs aiming to undergo international multi-centre clinical trials in China, it is no longer required that such drugs have already been registered overseas or have already entered Phase II or Phase III trials overseas.

2. For international multi-centre clinical trials conducted in China, after the completion of such trials, sponsors are eligible to directly apply for drug registration for marketing purposes.

3. For new chemical drugs and new biologics for therapeutical purposes which are under application for import into China, it is no longer a prerequisite that such drugs have received marketing approvals from the countries or territories in which the drug manufacturers reside.

4. For imported drugs applying for registration waivers that are currently under review by CFDA, if the waivers are based on international multi-centre clinical trials data, import permits can be granted as long as they meet relevant requirements.

Policy indications:

1) The existing “3-application-3-approval” process for imported drugs will be reverted back to the “2-application-2-approval” process.

2) CFDA encourages China to take part in global clinical trials concurrently. It is reasonable to predict that global pharma will invest more in China in new drug R&D and clinical trials.

3) More and more international multi-centre clinical trials will be conducted in China, which will bring huge opportunities for CROs.

4) The time needed for overseas new drugs’ entry into China will be dramatically reduced, by 3-5 years, that is.

5) It is likely that China can be the first country for an IND to get marketing approval.

6) The time needed for Chinese clinicians and patients to access latest drugs will be significantly shortened, esp in the serious diseases and rare diseases space.

7) Some Chinese domestic pharmaceutical companies may be knocked out of the market due to lack of competitiveness.

What it conveys, it seems, is that the CFDA has a strong determination to reform. And it takes unprecedented measures to make the reforms happen.

Do you agree with the above analysis? Comment below to let me know!

Sources (in Chinese):

1. http://www.sda.gov.cn/WS01/CL0778/170840.html

2. 微信公众号:临床研究大汇 2017.3.17

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