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CFDA Issued the Decision on Adjusting the Registration Administration of Imported Drugs
Date:2017-10-10
On October 10, 2017, CFDA issued the Decision on Adjusting the Registration Administration of Imported Drugs (CFDA Order No. 35), the full text of which is as follows: In accordance with the requirements of the Decision of the Standing Committee of the National People's Congress on Authorizing the State Council to Perform Marketing Authorization Holder System Pilot and Relevant Matters and the Opinions of the State Council on the Reform of the Review and Approval System for Drugs and Medical Devices (SC [2015] No. 44), to encourage the marketing of new drugs and meet clinical demands, several adjustments of the registration administration of imported drugs are made as follows upon decided by CFDA executive meeting through discussion: I. For the implementation of international multi-center clinical trials of imported drugs in China, allow phase I clinical trial to be conducted simultaneously in China and overseas and remove the requirement that the IND shall have been registered overseas or have entered phase II/phase III clinical trial (excluding biological products for preventive use).II. Upon completion of the international multi-center clinical trial in China, the applicant can submit NDA directly. Application of NDA shall comply with requirements of the Provisions for Drug Registration and relevant documents. III.For CTA for imported drugs, NDA for imported new chemical drugs, and NDA for imported innovative biological products for therapeutic use, remove the requirement that the product shall have been approved in the country/region of the overseas manufacturer. IV. If an applicant had applied for clinical trial exemption for an imported product using data generated from MRCTs for support and the application has been accepted by CFDA before the issuance of this Decision, CFDA can directly grant approval if the application comply with the requirements of the Provisions for Drug Registration and relevant documents. The Decision shall be implemented as of the date of release. If there is any discrepancy between the provisions in applicable regulations for imported drugs and this Decision, this Decision shall prevail.
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