Editor's Note: Monthly recap is a brief collection of recently-issued drug laws, regulations and policies in China, especially those issued by National Medical Products Administration (NMPA) and its affiliating office Center for Drug Evaluation (CDE).
1. eCTD Format for Drug Marketing Application Dossiers
NMPA will start to accept the electronic common technical document (eCTD) format for drug application dossiers on Dec. 29, 2021.1 Currently, the eCTD format is only applicable to Class 1 and Class 5.1 chemical drugs, and Class 1 therapeutic and prophylactic biological products.
The format is NOT mandatory but alternative, so drug applicants can stay with the current method—submitting compact disks containing dossiers. Read more about the eCTD requirements.
China eCTD Application Scope: Marketing Authorization Application Dossiers for Medical Products |
Class 1 chemical drug: An innovative chemical drug that has never been granted marketing authorization in or outside China. |
Class 5.1 chemical drug: An innovative or improved chemical drug with overseas marketing authorization and applying for marketing authorization in China. The improved drug shall have distinct clinical advantages. |
Class 1 therapeutic biological product: An innovative therapeutic biological product that has never been granted marketing authorization in or outside China. |
Class 1 prophylactic biological product: An innovative vaccine that has never been granted marketing authorization in or outside China. |
2. Medical Device or IVD Reagent Regulations
2.1. NMPA Underlines Points for Attention on Implementing Administrative Measures for Medical Device Registration and Filing and Administrative Measures for In Vitro Diagnostic Reagent Registration and Filing.
Before the two measures took effect on Oct. 1, 2021, NMPA pointed out noteworthy items on Sept. 29.2
For medical devices under the review but not yet approved before the implementation of the two measures, NMPA will continue the review and grant qualified devices according to the previous regulations.
For medical devices involving biological testing in their biological evaluation, the biological testing report shall be submitted with the marketing authorization application. If the report is from laboratories outside China, the applicant shall provide quality assurance documents proving that the laboratory complies with Good Laboratory Practice (GLP) requirements.
Medical devices imported to China shall be registered/filed by overseas registration/filing applicants. Medical devices manufactured by international companies in China shall be registered/filed by Chinese manufacturers.
2.2. NMPA Rolls Out the List of Medical Devices Exempted from Clinical Evaluation3 and the List of In Vitro Diagnostic Reagents Exempted from Clinical Trials4
The two lists, both released by NMPA on Sept. 18, allow stakeholders to spare themselves from conducting clinical evaluation/trials if the products are eligible for exemption.
A total of 1,010 categories of Class II/Class III medical devices and 423 categories of Class II/Class III IVD reagents are exempted from clinical evaluation or trials. Click here for exemption conditions and corresponding submission requirements.
2.3. NMPA Releases Format Requirements for Medical Devices' or IVD Reagents' Registration Application Dossiers and Approval Documents
Format Requirements for Registration Application Dossiers and Approval Documents | |
Medical Device5 | IVD Reagent6 |
① Medical Device Registration Certificate (Template) in the People's Republic of China ② Medical Device Variation Application/Filing Documents (Template) in the People's Republic of China ③ NMPA Feedback (Template) on the Review of the Clinical Trials for Medical Devices ④ Format Requirements for Medical Device's Registration Application Dossiers and Approval Documents ⑤ Requirements and Instructions on Medical Device's Registration Application Dossiers ⑥ Requirements and Instructions on Medical Device's Renewal Application Dossiers ⑦ Requirements and Instructions on Medical Device's Variation Filing/Registration Application Dossiers ⑧ Requirements and Instructions on Medical Device's Clinical Trial Application Dossiers ⑨ List of Essential Principles of Safety and Performance of Medical Devices | ① Medical Device (IVD Reagent) Registration Certificate (Template) in the People's Republic of China ② Medical Device (IVD Reagent) Variation Application/Filing Documents (Template) in the People's Republic of China ③ Format Requirements for Medical Device (IVD Reagent)'s Registration Application Dossiers and Approval Documents ④ Requirements and Instructions on IVD Reagent's Registration Application Dossiers ⑤ Requirements and Instructions on IVD Reagent's Renewal Application Dossiers ⑥ Requirements and Instructions on IVD Reagent's Variation Filing/Registration Application Dossiers ⑦ List of Essential Principles of Safety and Performance of IVD Reagents |
For English translations of the specific content in the regulatory documents above, welcome to contact us via contact@chemlinked.com.
2.4. Guidelines on Medical Devices and IVD Reagents
Guidelines | Medical Device7 | ①Technical Guidelines on the Clinical Evaluation of Medical Devices ②Technical Guidelines on Deciding Whether to Conduct Clinical Trials for Medical Devices ③Technical Guidelines on the Equivalence of Medical Devices in Clinical Evaluation ④Technical Guidelines on the Clinical Evaluation Report for Medical Device's Registration Application ⑤Technical Guidelines on Comparing Clinical-Evaluation-Exempted Medical Devices and Approved Devices ⑥The First Part of Inspection Guidelines on Animal Test Research for Medical Device Registration: Decision-making Principles ⑦The Second Part of Inspection Guidelines on Animal Testing Research for Medical Device Registration: Testing's Design and Quality Assurance During Implementation |
IVD Reagent8 | Technical Guidelines on the Clinical Evaluation of Clinical-Trial-Exempted IVD Reagents |
2.5. NMPA Releases Medical Device Industry Standards
On Sept. 9, NMPA released List of Medical Device Industry Standards9, which includes 63 standards with numbers, names, application scopes and implementation dates. The standards involve various medical devices, including face masks and relevant supplemental applications for treating sleep apnea.
2.6. NMPA, NHC and NHSA Stipulates Unique Device Identifiers (UDI)
Unique Device Identifiers have been implemented on 69 medical devices since Jan. 1 this year. Class 3 IVD reagents are also required to be labeled by UDIs, according to NMPA, National Health Commission (NHC) and National Healthcare Security Administration (NHSA).10
Since June 1, 2022, the 69 medical devices and Class 3 IVD reagents are required to adopt UDIs. Other medical devices are also encouraged by the authorities to do the same.
Applicants shall upload the stock keeping units’ or higher-level packages' UDIs to the Medical Device UDI Database, ensuring that the data is authentic, accurate, complete and traceable.
To ensure the UDI data is authentic, accurate, complete and traceable, for designated medical devices, applicants shall submit the stock keeping units' UDIs to the Registration Management System during first-time registration, renewal application or variation application.
3. Rx-to-OTC Switch
On Sept. 27, NMPA granted Aloe Vera Pearl Capsules, a formerly prescription (Rx) drug, over-the-counter (OTC) status.11
Rx-to-OTC Switch in China | Sept. 2021 | ||
Drug name | Strength | OTC Class |
Aloe Vera Pearl Capsules (Pinyin: Luhui Zhenzhu Jiaonang) | 0.5g/capsule | Class A |
Marketing authorization holders (MAHs) of the drug shall submit supplemental applications to provincial medical products administrations for labeling changes.
The MAHs shall also notify the changes to relevant healthcare institutions and suppliers. The English version of China's OTC catalog will be uploaded to BaiPharm Database.
4. A Collection of Sept. Guidelines Released by NMPA or CDE
If you need more details of the regulations mentioned above, welcome to contact us via contact@chemlinked.com.