Official Xuan: before the listing of dynamic commercial approval can be listed for sale!

Comprehensive:
On June 30, 2020, the Shanghai Municipal Drug Administration issued a notice on the implementation of the new revision of the Measures for the Supervision and Administration of Drug Production, and issued a notice on the commercial scale batch product listing and release managementthe newly revised Measures for the Supervision and Administration of Drug Production (Decree No28 of the State Administration of Market Supervision and Administration) will come into effect on July 1, 2020Article 16 of the Measures for the Supervision and Administration of Drug Production: Where new, remodeled or expanded workshops or production lines are built or built off site or offsite, the relevant materials and technical requirements shall be submitted to the relevant materials concerning the contents of the changes, and shall be reported to the drug production quality management departments of the provinces, autonomous regions and municipalities directly under the Central Government for compliance with the standards of compliance with drug production, and the results of the inspection shall be notified to the enterpriseThe inspection results are in accordance with the regulations, and the product sits on the market for sale if the product meets the requirements of releaseArticle 52 of the Measures for the Supervision and Administration of Drug Production: A commercial scale batch that passes a compliance inspection of the quality management specification selling of pharmaceutical production prior to the corresponding listing may be listed and sold after obtaining a certificate of registration of drugsDrug market license holders shall focus on strengthening the production, sale and risk management of the above-mentioned batches of drugsJune 30, 2020, the Shanghai Municipal Drug Administration issued a notice on the implementation of the new revision of the Measures for the Supervision and Administration of Drug Production, clearly on the commercial scale batch of products listed and released management requirements:for the pre-market drug GMP compliance inspection of commercial-scale batch of drugs, the holder may obtain a drug registration certificate for the listing of the release of the approval, in line with the listing and release requirements can be listed for saleThe holder shall formulate a quality risk management system for the batch of drugs to be released, focusing on strengthening the control and flow of sales channels, monitoring of adverse reactions, investigation and disposal of drug quality complaints, and emergency plans for drug safety, and relevant documents and records shall be collated and archived for reference in a timely manner.