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NMPA Announcement on the Issuance of 21 Medical Device Industry Standards such as YY / T 0464-2019 Single-Use Hemoperfutor and 1 Modification Order
2019-11-13
On November 13, 2019, NMPA issued the Announcement on 21 Medical Device Industry Standards such as YY/T 0464- 2019 Single-Use Hemoperfutor and 1 Modification Order. For the codes, names, scope of application and implementation date of the standards.
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NMPA Announcement on the Issuance of 13 Guidelines for Technical Review of the Registration of Augmented Extremity Compression Therapy Equipment and Others
2019-11-15
To strengthen the supervision and guidance over the registration of medical device products and further improve the quality of registration review, NMPA has organized the formulation of and released on November 15, 2019 the Guidelines.
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NMPA Announcement on the Issuance of Five Guidelines for Technical Review of the Registration of Human Chromosomal Abnormality Detection Reagents Based on Cytofluorometric In Situ Hybridization and Others
2019-11-15
NMPA has organized the formulation of and released on November 15, 2019 the Guidelines.
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NMPA Issued the Announcement on Revising the Package Inserts of Prescription and Over-the-counter Oral Preparations such as Huoxuezhitong Capsules
2019-11-08
On November 8, 2019, NMPA issued an Announcement with decisions made to revise the Entries of [warnings], [adverse reactions], [contraindications] and [precautions] of oral preparations (tablets, powders, soft capsules, capsules) such as Huoxuezhitong capsules.
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NMPA Released Announcement on the Application of 15 ICH Guidelines Including E1: Extent of Population Exposure to Assess Clinical Safety: For Drugs Intended for Long-term Treatment of Non-Life-Threatening Conditions
2019-11-12
On November 12, 2019, NMPA issued the Announcement on the Application of 15 ICH Guidelines Including E1: Extent of Population Exposure to Assess Clinical Safety: For Drugs Intended for Longterm Treatment of Non-Life-Threatening Conditions.
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NMPA Released Announcement on the Application of 13 ICH Guidelines Including S1A: Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals
2019-11-12
On November 12, 2019, NMPA issued the Announcement on the Application of 13 ICH Guidelines Including S1A: Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals.