Editor's Note: Monthly recap is a brief collection of recently-issued drug laws, regulations and policies in China, especially those issued by the following authorities:
National Medical Products Administration (NMPA);
NMPA's Center for Drug Evaluation (CDE);
National Health Commission (NHC);
National Healthcare Security Administration (NHSA).
China's Pharma Regulatory Dynamics in October 2021
NMPA Releases IVD Reagent Classification Rules
NMPA Greenlights 195 Medical Devices
NMPA Publishes Medical Device's Self-Test Rules
NMPA Rolls Out the 45th, 46th, and 47th Batches of Reference Listed Drugs
NHC Consults on Detailed Rules on the Supervision of Internet-based Diagnosis
CDE Releases Pharmaceutical Guidelines
1. IVD Reagent Classification Rules
On Oct. 29, NMPA released the In Vitro Reagent Classification Rules1 with immediate effect. The Rules only applies to the IVD reagents regulated as medical devices. IVD reagents intended for blood screening and IVD reagents labeled by radionuclide are not subject to the Rules.
IVD reagent are divided into three classes based on risk levels:
IVD Reagent Classification in China
Source: In Vitro Reagent Classification Rules effective since Oct. 29, 2021
Relevant regulation: IVD Reagent Registration and Filing in China effective since Oct. 1, 2021
1. Microbiological culture medium NOT for identifying microbes or testing drug allergies;
Cell culture medium ONLY for culturing microbes WITHOUT functions of selecting, inducing and differentiating cells, and the cultured microbes are for in vitro diagnosis.
2. Products for processing samples, e.g., hemolysis reagents, dilution solutions, stain solutions, nucleic acid extraction reagents.
3. General reagents for the reaction system, e.g., buffer solution, substrate solution.
IVD reagents, except for the Class I and Class III ones, are defined as Class II products, which mainly includes the following products:
1. Reagents for testing proteins;
2. Reagents for testing saccharide;
3. Reagents for testing hormones;
4. Reagents for testing enzymes;
5. Reagents for testing esters;
6. Reagents for testing vitamins;
7. Regents for testing inorganic ions;
8. Reagents for testing drugs and drug metabolites;
9. Reagents for testing autoantibodies;
10. Reagents for identifying microbes or testing drug allergies; cell culture medium for identifying microbes, with functions of selecting, inducing and differentiating cells, and the cultured microbes are for in vitro diagnosis;
11. Reagents for testing allergic reactions (allergens);
12. Reagents for testing other physiological, biochemical and immune function indicators.
1. Reagents for testing pathogenic antigens, antibodies and nucleic acids;
2. Reagents relevant to blood matching and tissue typing;
3. Reagents relevant to human genetic testing;
4. Reagents relevant to hereditary diseases;
5. Reagents relevant to testing anesthetic, psychiatric drugs and toxic drugs for medical use;
6. Reagents relevant to testing the targets of therapeutic drugs; companion diagnostics (CDx);
*CDx are tools for evaluating the safety and effectiveness of corresponding medical products. CDx are mainly used before and/or during treatment. They identify patients who are most likely to benefit from the corresponding medical product or at increased risk of severe adverse reactions as the result of treatment with the corresponding medical product.
7. Reagents relevant to cancer screening, diagnosis, companion diagnostics, staging, etc.
2. NMPA Greenlights 195 Medical Devices
On Oct. 18, NMPA released the list of newly-approved 195 medical devices. 26 of them are imported Class III high-risk medical devices, including Sorin Group Italia S.r.l.'s Accessories for the Perceval Sutureless Aortic Heart Valve and Roche's Global Cal.
36 approved medical devices are imported as Class II moderate-risk products, including Abbott's Magnesium Assay Kit (enzymatic method) and HS HOSPITAL SERVICE S.p.A.'s Coaxial Biopsy Needle.
Relevant regulation: Medical Device Registration and Filing in China.
3. Administrative Rules on Self-Test of Medical Devices
NMPA now allows Chinese and international companies to conduct self-tests for medical devices, says the Administrative Rules on Self-Test of Medical Devices which took effect on Oct. 2021.3
On the one hand, the Rules brings flexibility. Besides designated Chinese labs, companies can choose one of the following methods to do self-tests:
(1) Conduct the self-test by the registrant company. The registrant shall submit relevant documents proving it meets the capability requirements of conducting self-tests. The registrant shall also issue a self-test report.
(2) Entrust the self-test to the manufacturer that meets the self-test capability requirements. The registrant company shall issue a self-test report.
(3) Ask an accredited lab inside the registrant's corporate group or the group's subsidiary to conduct the test for the registrant.
For a Chinese registrant, the lab, which is inside the registrant's corporate group or the group's subsidiary, shall be accredited by China National Accreditation Service for Conformity Assessment (CNAS).
For an international registrant, it can apply for its corporate group's authorization to use the lab inside the registrant's corporate group or the group's subsidiary. The lab shall be accredited by the local government or by government-authorized institutes for lab accreditation.
Both Chinese and international registrants shall issue a self-test report.
Self-tests are expected to simplify product registration procedures, especially for international companies, as they no longer have to wait for the designated labs.
On the other hand, the Rules is strict. It requires registrant companies that do self-tests by themselves to show the to comply with regulatory requirements regarding personnel, facilities, sample products, quality control, testing records, testing reports, etc. If a fraudulent self-test report is submitted for product registration, the registrant shall be punished according to Administrative Measures for Medical Device Registration and Filing.
4. The 45th, 46th, and 47th Batches of Reference Listed Drugs
In Oct. 2021, NMPA rolled out the 45th4, 46th5, and 47th6 batch of RLDs, each with 51, 54, and 38 drugs. The RLDs play a significant role in generic drugs' bioequivalence studies because generics shall be proved consistent with the RLDs in quality and effectiveness. The information of three batches of RLDs will be translated into English and uploaded to BaiPharm Database soon.
5. Detailed Rules on the Supervision of Internet-based Diagnosis (Consultation Draft)
On Oct. 26, 2021, National Health Commission consults on the Detailed Rules on the Supervision of Internet-based Diagnosis7. The consultation draft stipulates that online physicians shall diagnose with their true personal identities. Artificial intelligence (AI) or other person shall NOT masquerade as or replace the physicians in diagnosis.
The consultation draft asks medical centers to enhance drug product management during internet-based diagnosis, e.g., forbidding medical staff from reaping profits by sending prescription statistics to pharmaceutical sales representatives.
If you have advice for China's internet-based hospital regulation, welcome to fax it to NHC via 010-68792195 before Nov. 26.
6. Pharmaceutical Guidelines
Pharmaceutical Guidelines Released in Oct. 2021
Writing Guidelines on Application Documents for Theories on New TCM Compound Preparations (Trial) and Writing Guidelines on Medication Package Inserts of TCM Compound Preparations Derived from Ancient Classical and Famous Prescriptions (Trial)
If you need more details of the regulations mentioned above, welcome to contact us via firstname.lastname@example.org. Our BaiPharm Team offers a full portfolio of China NMPA compliance consulting services. Back by our experienced experts, we ensure professional response and full support for our clients.