Overview:

China’s National Medical Product Adminstration (NMPA) announces a new revised Drug Administration Law of the People’s Republic of China (effective since Dec 1, 2019) to implement relevant requirements of the Drug Administrative Law and clarifies the supervision of the drug distribution in China.

Key changes to the Revised law:

As per the revised law, the following matters are announced:

  1. As per the newly Drug Administration Law, (Former CFDA order No. 6) Regulations on Drug Distribution License and (Former CFDA order No. 26) Provisions for Supervision of Drug Distribution remains valid.
  2. For a new drug distribution license, the drug administration may combine examination and approval procedures and organize inspection over the site. If relevant requirements are met (for example Good Supply Practice for Pharmaceutical Products (GSP)), the license shall be issued.
  3. For renewal of drug distribution license, the drug administration will inspect the site. If requirements like GSP and other relevant requirements are met, the license shall be issued.
  4. If a drug distribution license has been cancelled or withdrawn before Dec 1, 2019, the drug administration will reconsider a license application and the applicant can apply for a license. For this, the drug distributor can apply for resumption of operation and resume business activities if the conditions are met after review by drug administration.
  5. Drug distributors are abided to follow Article 34 of the drug administration law. This means, entrusted drug manufacturer may sustain drug sales within a year contract but not more than that. As per the Drug Administration Law, the Marketing Authorization Holder cannot sign contracts with entrusted manufacturers.
  6. Drug Marketing Authorization Holders, manufacturers, distributors and User units should comply with NMPA Guiding Opinions on the Construction of Drug Information Traceability System.

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