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Medical News,September 3,August 30,the Center for Drug Evaluation of the State Food and Drug Administration(hereinafter referred to as the Center for Drug Evaluation)on the"procedures and requirements for changes in the filing of overseas-produced drugs after marketing(draft for comments)"(hereinafter referred to as"Draft for Comment")for a two-week public consultation.The"Draft for Solicitation of Opinions"proposes that the time limit for reviewing changes in the filing of overseas-produced drugs after marketing is 60 working days.

The"Draft for Solicitation of Opinions"puts forward the application scope,procedures,and work requirements for changes in the filing of overseas-produced drugs after they are on the market.Relevant content shows that the applicant uploads electronic data in the State Drug Administration system in accordance with the requirements of the"Administrative Measures for Drug Registration"and related documents,submits a filing application,obtains the filing number,and completes the data reception by the system.At the same time,the applicant sends a set of original paper version materials to the Center for Drug Evaluation,and promises that the content of the paper version materials is consistent with the contents of the electronic version materials.The State Drug Administration shall publicize the record information within 5 days from the date of completion of the record.

Within 60 working days after the self-filing task enters the drug review center system,the drug review center completes the post-mortem review of the filing data.If objections are raised to the contents of the record after review,report to the State Food and Drug Administration,and change the publicity status of the remarks in the“Announcement of Information on Recording of Overseas Produced Drugs”on the website of the State Food and Drug Administration from“documented”to“objectionable”and explain the reasons.When necessary,submit inspection and inspection requirements to the State Food and Drug Administration.

According to the"Draft for Solicitation of Comments",if the applicant determines the change management category of overseas-produced drugs in accordance with the relevant technical guidelines,he can directly apply for the record-based change;if it cannot be confirmed or intends to reduce the change management category,the applicant can follow the"Post-Marketing Drugs"Change Management Measures(Trial)"related requirements,and submit a communication application to the Center for Drug Appraisal.