1. Objective: Drug filing is to ensure that the production and sale of drugs meet the regulatory requirements, which is the guarantee of drug safety. The purpose of drug registration is to examine whether the developed drugs meet the registration requirements, so as to protect public health and safety.
2. Process: Relevant documents need to be submitted to the State Administration of Medical Supplies for review, mainly to evaluate the safety, effectiveness and quality controllability of drugs. If the evaluation results meet the requirements, they shall be put on record. However, drug registration needs to submit a registration application to the State Administration of Medical Supplies, and then go through a series of strict registration procedures, including technical review and on-site inspection, to determine whether the safety, effectiveness and quality of drugs meet the registration requirements.
3. Results: The result of drug filing is to obtain a filing certificate, which shows that the drug meets the regulatory requirements and can be listed. The result of drug registration is to obtain registration approval, that is to say, the safety, effectiveness and quality of drugs meet the registration requirements and can be officially approved for listing.
Generally speaking, drug filing is to ensure the safety and quality of drugs, while drug registration is a further confirmation and permission of these attributes, and the requirements are more stringent.