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Imported Drug Registration Procedures Set to be Streamlined

The procedures for registering imported drugs have been revised by the China Food and Drug Administration (CFDA). The new measures are intended to simplify the process and to meet the growing demand for new pharmaceutical products across the mainland.

The four key measures announced are as follows:

  1. In all instances where the international multi-centre clinical trial of a drug has been conducted in China, Phase I of the clinical trial will be allowed to proceed simultaneously. The previous requirement that the drug subject to the clinical trial must have previously been registered abroad or have entered Phase II, III or a period of clinical trial no longer applies. Biological products intended for prophylactic use, however, are not covered under the terms of this provision.
  2. Once an international multi-centre clinical trial has been completed, the applicant may directly apply for the drug to be registered and launched in China. This is providing the drug complies with the requirements detailed in the Administrative Measures for Drug Registration and all other relevant legislation.
  3. The requirement that a drug must have obtained a market release permit in its manufacturers’ home country or region prior to petitioning to launch or to commence clinical trials in China no longer applies.
  4. Should any registration application with regard to the clinical trial exemption of any imported drug, supported by appropriate data from an international multi-centre clinical trial, have already been accepted prior to the implementation of these new procedures, the import of the drug in question could be directly approved as long as all the requirements detailed in the Administrative Measures for Drug Registration and other relevant legislation have been complied with.

For further details (in Chinese), please refer to the following link:

Decision of CFDA on Adjusting Relevant Matters Concerning the Administration of Imported Drug Registration (CFDA Order No. 35)

Content provided by Picture: HKTDC Research
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