China NMPA Announces Cancellation of Three Medical Device Registrations, Issues Alert on Four Substandard Drug Batches, and CDE Seeks Public Comments on ICH Q5A(R2) Implementation

Dec 12, 2023 20:16 CST Updated 20:16

Covidien Healthcare

Medical Product Manufacturer

Notice of the National Medical Products Administration on the Cancellation of Registration Certificates for 3 Medical Devices Including Polypropylene Hernia Repair Mesh (No. 155 of 2023)

In accordance with the Regulations on the Supervision and Administration of Medical Devices, and based on the enterprise's application, the medical device registration certificates for the following three products from two enterprises are hereby canceled:

1. Two products from Covidien Healthcare International Trading (Shanghai) Co., Ltd.:

Polypropylene hernia repair mesh, Registration No.: GuoXieZhuZhun 20223130653;

Polypropylene Hernia Repair Mesh, Registration Certificate No.: Guo Xie Zhu Zhun 20223130335.

2. Ailekang Co., Ltd. 1 product:

Silicone Wound Dressing, Registration Certificate No.: G20153141752.

Notice of the National Medical Products Administration on 4 Batches of Non-Conforming Pharmaceuticals (No. 65, 2023)

Tested by Guizhou Institute for Food and Drug Control and other three drug inspection agencies, four batches of drugs were found non-compliant. The relevant information is hereby announced as follows:

1. According to the inspection by the Guizhou Provincial Institute for Food and Drug Control, one batch of Kanggongyan Tablets sampled from Chongqing Jiang'anfang Pharmaceutical Co., Ltd. did not meet the specifications. The non-conforming item was microbial limits.

As per the inspection by the Shanghai Institute for Food and Drug Control, one batch of Tacrolimus Ointment sampled from Sinopharm Holding Tianhe Jilin Pharmaceutical Co., Ltd. was found non-compliant, with the non-conforming item being related substances.

According to the inspection by Shenzhen Institute for Drug Control, one batch of fried Bombyx Batryticatus sampled from Chunyuantang Clinic did not meet the specifications, with the non-conforming item being total ash content.

According to the inspection by Qinghai Institute for Drug Control, one batch of processed licorice sampled from Naqu Huijin Hospital did not meet the specifications, with the non-conforming item being content determination.

II. For the above-mentioned non-compliant drugs, the drug regulatory authorities have required relevant enterprises and units to take risk control measures such as suspending sales and use, and recalling products. Investigations into the causes of non-compliance have been launched, and concrete corrective actions are being implemented.

3. The National Medical Products Administration requests that relevant provincial medical products supervision and administration departments, in accordance with the "Pharmaceutical Administration Law of the People's Republic of China," organize investigations into the alleged illegal activities of the aforementioned enterprises and units, and publicly disclose the investigation results as required.

Attachment:

List of 4 Batches of Non-Conforming Drugs.docx

Knowledge about non-compliant items.docx

Notice on Publicly Soliciting Implementation Suggestions and Chinese Version Opinions for ICH "Q5A(R2): Viral Safety Evaluation of Biotechnological Products Derived from Human or Animal Cell Lines"

To promote the smooth implementation of the newly revised ICH guidelines in China, our center has formulated "Implementation Suggestions," while also organizing the translation of Q5A (R2) into Chinese. The implementation suggestions and the Chinese version are now open for public comments for a period of 1 month.

If you have any comments or suggestions, please send them to the contact person's email address: gkzhqyj@cde.org.cn.

Attachment:

Q5A(R2): Implementation Suggestions for Viral Safety Evaluation of Biotechnological Products Derived from Human or Animal Cell Lines.docx

Q5A(R2): Viral Safety Evaluation of Biotechnology Products Derived from Human or Animal Cell Lines (Chinese Version).doc

Q5A(R2): Viral Safety Evaluation of Biotechnology Products Derived from Human or Animal Cell Lines.pdf

Editor: Zhu Di