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NMPA Issues Guidance for the Preservation of Essential Documents for Drug Clinical Trials
2020-06-08
NMPA organized the formulation of the Guidance for the Preservation of Essential Documents for Drug Clinical Trials, which has been released on June 8, 2020 and shall come into effect as from July 1, 2020.
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NMPA Issues Guidelines for Evaluation of Changes in Raw Materials of Passive Medical Devices
2020-05-19
NMPA organized to formulate and released on May 19, 2020 the Guidelines for Evaluation of Changes in Raw Materials of Passive Medical Devices.
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NMPA Issues Technical Review Guidance for the Registration of Dengue Virus Nucleic Acid Detection Reagents
2020-05-14
NMPA organized to formulate and released on May 14, 2020 the Technical Review Guidance for the Registration of Dengue Virus Nucleic Acid Detection Reagents.
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NMPA Announcement on Revising the Package Inserts of Sodium Aescinate for Injection
2020-05-07
On May 7, 2020, NMPA issued an Announcement with decisions made to revise the [adverse reactions], [precautions] and other Entries on the package inserts of sodium aescinate for injection
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NMPA Announcement on Revising the Package Inserts for Polyene Phosphatidylcholine Injection
2020-05-07
On May 7, 2020, NMPA issued an Announcement with decisions made to revise the [adverse reactions], [precautions] and other Entries on the package inserts of Polyene Phosphatidylcholine Injection
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NMPA and NHC Issued the Announcement on Good Clinical Practice
2020-04-26
NMPA, in conjunction with NHC, has organized the revision of the Good Clinical Practice (GCP), which has been released on April 26, 2020, and shall enter into effect as from July 1, 2020.