PHDS HEALTHCARE RESEARCH Co., Ltd.
The "Decision of the National Medical Products Administration on Adjusting the Registration Management of Imported Drugs" was reviewed and approved at the executive meeting of the National Medical Products Administration on June 20, 2017, and is now announced, effective from the date of publication.
Release time:
2017-10-10
Decision of the National Medical Products Administration on Adjusting the Registration Management of Imported Drugs
National Medical Products Administration
Decision on Adjusting Relevant Matters of Imported Drug Registration
The CFDA decision to adjust relevant matters of imported drug registration
(October 10, 2017)
In accordance with the "Decision of the Standing Committee of the National People's Congress on Authorizing the State Council to Carry Out Pilot Programs for Drug Marketing Authorization Holders in Certain Areas and Related Issues" and the "Opinions of the State Council on Reforming the Review and Approval System for Drugs and Medical Devices" (Guo Fa [2015] No. 44), in order to encourage the market launch of new drugs and meet clinical needs, the National Medical Products Administration has decided to make the following adjustments to the management of imported drug registration:
1. For international multi-center drug clinical trials conducted in China, Phase I clinical trials are allowed to be conducted simultaneously, and the requirement that the drugs for clinical trials must be registered abroad or have entered Phase II or III clinical trials is canceled, except for preventive biological products.
Regarding the international multi-center pharmaceutical clinical trial in China, it is allowed to perform the Phase I clinical trial in parallel in China. The requirement that the drugs to perform their clinical trials in China should be marketed or enter their Phase II or III clinical trials abroad is canceled, however, the preventive biologicals are excluded.
2. After the completion of international multi-center drug clinical trials conducted in China, the applicant can directly submit a drug market registration application. When submitting the market registration application, the requirements of the "Drug Registration Administration Methods" and related documents must be followed.
After the international multi-center clinical trials are completed, the applicant for drug application can directly apply for market authorization of their drug. During the drug registration, the Drug Registration Administration Methods and its Annexes shall apply.
3. For new chemical drugs and innovative therapeutic biological products that apply for clinical trial applications and market authorization for imported drugs, the requirement to obtain market authorization from the country or region of the foreign pharmaceutical manufacturer is canceled.
For the application of imported new chemical drug clinical trials and imported drug market authorization in China, if the drug is a new chemical drug or a new therapeutic biological, the precondition for registration that the drug must be marketed in the country of origin is canceled.
4. For applications that were accepted before the issuance of this decision, which apply for exemption from clinical trials by submitting international multi-center clinical trial data and meet the requirements of the "Drug Registration Administration Methods" and related documents, direct approval for import can be granted.
For the applications before this decision, if applying for a waiver of clinical trial by submitting international multi-center clinical trial data and the dossier can meet the requirements of the Drug Registration Administration Methods and its Annexes, the drugs being registered can be approved directly for importation.
This decision is implemented since its issuing date. If any discrepancies from other drug administrative regulations, this decision shall apply.
This decision is implemented since its issuing date. If any discrepancies from other drug administrative regulations, this decision shall apply.
Keyword:
Relevant regulations and policies
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