China: New updates on Medical Devices, Drugs, COVID-19 and Cosmetics

Newsletter on medical products has been issued on ChinaDaily, on the new updates and information on medical devices, drugs, COVID-19 and cosmetics.

Medical Devices: NMPA announcement

1. Issuing of Two Registration Technical Review Guidelines Including the Guidelines for Technical Review of Clinical Evaluation of Ultrasound Diagnostic Imaging Equipment Based on Predicate Products

2. Issuing the Catalogue of Medical Devices Exempt from Clinical Trials (Revised Second Batch)

3. Issuing Three Guidelines for Technical Review of the Registration Including that of Mycoplasma Pneumoniae IgM/IgG Antibody Detection Reagents

Drugs

1. Center for Drug Evaluation of NMPA Announced on Issuing the Administrative Measures for Communication of Drug R&D and Technical Review

2. SAMR Released the Provisions for the Lot Release of Biological Products

3. Issues Pertaining to Online Application for Drug Registration Affairs

4. Issuing the Provisions for the Change Management of Post-approval Drugs (Interim)

5. Cancellation of Registration Certificates for Phenolphthalein Tablets and Phenolphthalein Buccal Tablets

6. Revising the Package Inserts of Sulfasalazine Preparations

7. Application of ICH Guideline E9 (R1): Estimands and Sensitivity Analysis in Clinical Trials

COVID-19

1. The State Administration for Market Regulation, the National Medical Products Administration, and the China National Intellectual Property Administration Jointly Commend Advanced Collectives and Advanced Individuals in Fighting the COVID-19 Pandemic.

Cosmetics

1. SAMR Issued the Provisions for Registration and Notification of Cosmetics.

Source: nmpanewsletter202101.pdf (chinadaily.com.cn)

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