In China, drug registration is an amalgam of certain procedural steps. These steps have various entities, including the Marketing Authorization Holder (MAH), sponsor, etc., accountable for different drug approval phases.
A sponsor is defined as a company, institution, or organization approved to carry out and initiate a clinical trial. This entity manages, finances, and monitors clinical trials.
A clinical trial sponsor may give a Contract Research Organization (CRO) permission to perform specific tasks and fulfill responsibilities. The sponsor may delegate some or all of the work associated with the clinical trial to the CRO. But the sponsor retains the ultimate responsibility for the accuracy and validity of the clinical trial data and oversees the CRO's performance of its various duties. If the sponsor changes, the new sponsor must bear the responsibilities and obligations of the drug’s clinical trial.
The sponsor is also called as the “holder of the drug marketing license.” The clinical trial application must be submitted by a Chinese legal entity, regardless of the sponsor's nationality.
The legal representative and the person holding the drug marketing license are solely responsible for the drug’s quality used in a clinical trial. When the license holder is an overseas entity, their designated legal person in China must fulfill the same obligations as the holder of the drug marketing license and endure joint and other liabilities with the sponsor.
Clinical trial approval is an integral part of the drug registration process in China. Therefore, it is a prime requirement to be well versed and updated with the Chinese drug regulations.
Freyr is a Regulatory-focused organization that supports life sciences companies in registering their drug products in China. To know more about Freyr’s Regulatory capabilities in China.