Pharmaceutical Network November 24th. It is reported，At the end of December 2015，Message of GMP certification of sterile preparations under the official announcement。

 

 

The National Bureau has recently issued documents to various provincial My stake betting appstake sports betting appbureaus，Require provincial bureaus to prepare，GMP authentication work with sterile medicine。At the same time, all provincial bureaus are required to improve and improve the certification management system，Perfect the certification work program，Strengthen inspection capacity building，Guarantee certification work quality。

 

 

The State Administration recently issued the "Guidelines for Sterile Drug Inspection" at the same time、"Technical Review of Drug GMP Certification Reporting Information"、"Pharmaceutical GMP Certification Live Inspection Work Procedure"、"Principles Guidance Principles of the Risk Assessment of Drug Production on -site"、"Drug GMP on -site inspection defect project rectification requirements"、"Technical Guide Documents and other technical guidelines such as the drug inspection institution evaluation manual"，It seems that the National Bureau is prepared for this time，Make sure that after the GMP authentication is decentralized，GMP certification level does not decrease，GMP certification level Stake Sports Bettingin each province、Standard My stake betting appshould be unified as possible。

 

 

Sterile GMP authentication has a conclusion early

 

 

The official website of the State Administration on May 15, 2013 "Regulations on the Compilation of the State Administration of Food and Drug Administration's main responsibilities and personnel" (commonly known as & ldquo;，Main functions、Institutional settings and staffing)，& ldquo; San Ding solution & rdquo; The responsibilities of the regulations include: & ldquo;、Medical Devices Quality Management Standardized Certification Disposure Disposal Disputes of Provincial Food and Drug Supervision and Administration & RDQUO;。

 

 

but，The scheme does not give a clear timetable，Shortly after the plan was released，Some media published articles at the time thinking，The initial time is to start the drug GMP certification right on January 1, 2015, and the batch will be put into the provincial bureaus in batches，Including injection、Radioxids、Blood Products、Biological products and other high -risk drugs。

 

 

The scheme also clarifies that the establishment stake betting appof new institutions has canceled 5 duties，Including My stake betting apptwo licenses of drug production license and GMP certification, gradually integrated into a production administrative license，Two licenses of administrative licenses of drug management and GSP certification (drug business quality management specification) gradually integrate into one business administrative license。

 

 

Chinese medicine drinking tablets GMP certification may be decentralized to various municipal bureaus

 

 

It is reported，The National Bureau puts the sterile GMP certification in the provincial bureau，Provincial bureaus In order to reduce the pressure of GMP certification work、Improve GMP certification efficiency，Provincial Bureau may be based on GMP certification，Gradually put Chinese medicine drinking tablet GMP certification permissions in various municipal bureaus。