Editor's Note: the monthly recap is intended to bring you recent major laws and regulations issued by China drug regulators, including National Medical Products Administration (NMPA) and the Center for Drug Evaluation (CDE).
1. China NMPA Adopts ICH Principles on Biological Products
On Apr. 28, China NMPA announced that it had decided to adopt the guidelines in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)'s documents of M9: Biopharmaceutics Classification System-based Biowaivers, M9 Questions and Answers, and Q5D: Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products.1
China NMPA announced that for relevant research that started within six months (according to the trial time on record) since NMPA made the announcement, the registration applicants shall conform to the newly adopted ICH guidelines and the existing technical requirements. Relevant technical guidelines are available for reference on NMPA's website: nmpa.gov.cn.
2. China NMPA Publishes New Pharmacovigilance Guidance
NMPA issued the Good Pharmacovigilance Practice (GVP) on May 13, 2021, to regulate and guide pharmacovigilance activities. The new GVP is set to come into enforcement on Dec. 1, 2021.2
The Chinese GVP applies to pharmacovigilance activities carried out by
① Marketing Authorization Holders (MAHs) and
② drug registration applicants with authorization to carry out clinical trials.
ChemLinked BaiPharm has provided the details of the GVP at: https://baipharm.chemlinked.com/news/china-to-implement-good-pharmacovigilance-practices.
3. China NMPA Takes New Measures for GMP & GSP Inspection
On May 28, China NMPA issued Administrative Measures on Drug Inspection (Trial) (hereafter referred to as Administrative Measures) with immediate effect.3 The Administrative Measures displaces two former regulations on drug inspection—Administrative Measures on the Certification of Good Manufacturing Practices (GMP) for Drugs and Administrative Measures on the Certification of Good Supply Practices (GSP) for Drugs.
China has canceled the GMP and GSP certifications since implementing the Drug Administration Law in 2019. Now, inspectors supervise the drug manufacturing and supply activities according to Administrative Measures on Drug Inspection (Trial).
For specific details of the Administrative Measures, please access to ChemLinked BaiPharm's previous report at baipharm.chemlinked.com/news/china-takes-new-measures-for-gmp-gsp-inspection.
4. China NMPA Announces Requirements for Implementing Regulations for the Supervision and Administration of Medical Devices
On May 31, 2021, NMPA announced requirements for implementing the Regulations for the Supervision and Administration of Medical Devices (hereafter referred to as the Regulations) approved by the State Council on Dec. 21, 2020.4
On June 1, 2021, NMPA started to implement the following system and regulations according to the Regulations:
(1) System of Medical Device Registrant/Filing Person
Companies and research & development institutes are
① registrants if they have obtained the medical device registration certificates; or
② filing persons if they have a record of filing for Class 1 medical devices.
Registrants or filing persons shall ensure the safety and efficacy of the medical devices during the whole product life cycle, including manufacture, supply and usage.
(2) Clinical Evaluation of Medical Devices
① Exemption of clinical evaluation
Registrants and filing persons can skip clinical evaluation if meeting one of the following conditions5:
The medical device has a clear work mechanism and a fixed design, and is produced with mature technologies. There is a same type of previously approved product that has been clinically used for years with no record of severe adverse events. Also, the new medical device's functions are kept the same as the normal ones of its precedent.
There are other methods to prove that the new medical device is safe and effective.
② Conducting clinical evaluation
Registratnts/filing persons shall conduct clinical evaluation if the current documents and data are insufficient to ensure the safety and efficacy of the medical device.
Clinical trial evaluation can be conducted according to product characteristics, clinical risks, existing clinical data, etc. Otherwise, it can be carried out through the analysis of the documents and clinical data of the same kind of product.
Medical device registrants and filing persons shall follow the existing technical requirements for manufacturing/supplying license or record-filing before specific relevant regulations come out.
ChemLinked BaiPharm has reported the current requirements for filing master files of medical devices. Please check out baipharm.chemlinked.com/news/china-launches-medical-device-master-file-system.
