Monthly Recap: China Pharmaceutical Regulatory Updates | November 2021

by Grace Wang Dec 16, 2021

Editor's Note: Monthly recap is a 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);

  • State-led Joint Drug Procurement Office.

1. Insulin VBP Tender Result

China insulin VBP (volume-based procurement) tender's final result came out on Nov. 30.1 11 drug makers, including Novo Nordisk, Eli Lilly, Sanofi, Gan & Lee, and the United Laboratories, won the bid for supplying a total of over 212 million insulin doses to public healthcare institutions across China. Read further analysis here.

2. Drug Supply Information Submission System

On Nov. 3, NMPA launched a system for companies to submit the supply information of drug products in shortage2 and active pharmaceutical ingredients (API)3. Here are essential requirements for the submission.

NMPA-Required Submission of Drug Supply Information


Drugs in Shortage

API

Scope

Drug products listed in the National Drug Shortage List and the National Clinically-necessary Drug Susceptible to Shortages and Under Intensive Monitoring.

APIs used in drug products listed in the National Drug Shortage List and the National Clinically-necessary Drug Susceptible to Shortages and Under Intensive Monitoring.

Info to be   submitted

  • manufacturing & supplying info: drug name, production volume, purchaser's name, purchaser's type,  supply area (province), quarterly sales volume, etc.

  • discontinued production info: drug name, discontinuation time, current storage volume, planned date for production resumption, etc.

  • manufacturing info: API name, approval number, production date, storage start date, shelf life, production volume, storage volume, etc.

  • supplying info: API name, approval number, purchaser's name, supplier's location (province), sales volume, etc.

  • storage info: API name, approval number, production date, shelf life, storage volume, etc.

Submitter

Chinese marketing authorization holders (MAH) of drug products, or Chinese corporate legal persons of the overseas MAHs.

Chinese API manufacturers, or Chinese corporate legal persons of overseas API manufacturers.

Time to Submit

  • Manufacturing & supplying info: 2021 Q3 info shall be submitted before the end of November. Future quarterly info shall be submitted within the first 20 days of next quarter.

  • Discontinued production info: submitted within six months before the planned discontinuation or three days before unexpected discontinuation.

Manufacturing & supplying info: 2021 Q3 info shall be submitted before the end of November. Future quarterly info shall be submitted within the first 20 days of next quarter.

 

3. Documentation for Import/Export Permit of Analgesics and Antipsychotics

On Nov. 30, NMPA released the Requirements for Documentation for Applying for Import/Export Permit of Analgesics and Psychoactive Drugs.4

NMPA requires international companies, which plan to sell relevant drugs to China only for clinical use, to submit documents including the analgesic/psychoactive drug import application form, a copy of the sales contract/order, a copy of drug approval document, etc.

4. One Rx-to-OTC Switch

On Nov. 9, NMPA changed Buxuxiaoke Compound Solution from a prescription (Rx) drug to over-the-counter (OTC) drug.5

Rx-to-OTC Switch in China | Nov. 2021

Drug name

Strength

OTC Category

 Classification

Buxuxiaoke Compound Solution (previous name: Tangtaide Compound Solution)

10ml/bottle or 120ml/bottle

Category I

 TCM

OTC drugs refer to drugs which can be purchased or used by consumers without prescriptions from licensed doctors or pharmacists. Category II OTC drugs are recognized by China NMPA as safer than Category I ones. China's OTC drug catalog will be regularly updated in BaiPharm Database.

5. The 48th Batch of Reference Listed Drugs

On Nov. 10, NMPA released the 48th batch of Reference Listed Drugs (RLD). The batch covers 57 drugs, including Janssen-Cilag AG's Topiramate Capsules and Sanofi-Aventis France's Metoclopramide Hydrochloride Injection.6

The RLDs are reference products to which new generic drugs are compared to demonstrate bioequivalence. The generics proposed for marketing authorization have to show consistency with the reference product in quality and efficacy. Try search for an RLD in BaiPharm Database.

6. 110 Recently-Approved Medical Devices

On Nov. 15, NMPA announced that in October, it had approved 110 medical devices, among which 29 were imported products, including CAScination AG's Navigation Systems for Interventional Radiology and Abbott Medical’s AdvisorTM VL, Sensor EnabledTM Circular Mapping Catheter.7

7. Administrative Measures for National Essential Medicine List (Revised Draft)

On Nov. 15, NHC consulted on the Administrative Measures for National Essential Medicine List (Revised Draft). The revised draft says the list will be evaluated periodically and adjusted every three years in principle.8

8. Administrative Measures for Quality Supervision in Drug Supply, Distribution and Use (Consultation Draft)

On Nov. 12, NMPA solicited public opinions on the Administrative Measures for Quality Supervision in Drug Supply, Distribution and Use (Consultation Draft). Compared to the previous draft, this draft elaborates further on drug MAHs' responsibilities.

According to the current draft, procedures are easier for MAH to entrust manufacturing activities. Instead of filing a record, MAH that outsources production only needs to report to the local drug regulator of the administrative area where the MAH is.9 Read more about China's MAH system.

9. Administrative Rules on Pause and Resumption Timing of NMPA's Drug Review (Trial)

On Nov.4, CDE consulted on the Administrative Rules on Pause and Resumption Timing of NMPA's Drug Review (Trial). The rule says during a drug review, the time between a pause and a resumption won't be counted into the review time.10 Read about China's four expedited programs for shortening review time and accelerating marketing approval.

10. Catalog of Medical Devices Banned from Manufacturing Entrustment (Consultation Draft)

On Nov. 19, NMPA released the Catalog of Medical Devices Banned from Manufacturing Entrustment (Consultation Draft). The catalog covers 22 categories of medical devices, including implantable pacemakers and aneurysm clips.11

11. Administrative Measures for Medical Device's Adverse Event Monitoring and Reevaluation (Revised Draft of the Amendent)

On Nov. 23, NMPA asked public comments on the Administrative Measures for Medical Device's Adverse Event Monitoring and Reevaluation (Consultation Draft of the Amendment). The amendment specifies that medical device registrants/filer should be a corporate or research body that has obtained registration certificates or filed records.12

The draft amendment also says registrants/filers shall receive punishment if they commit the following wrongdoings:

  • Failing to collect or submit adverse event reports within time limits;

  • Submitting reports with intentionally incomplete or false data;

  • Failing to submit adverse event evaluation result or investigation report within time limits;

  • Refusing to cooperate with medical products administrations and testing institutes in adverse event investigations.

12. Guidelines/Guidance/Requirements

No.

Guidelines/Guidance/Requirements

Note

Authority

Release

1

ICH M3 (R2)—Guideline on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals and ICH Guideline M3 (R2) – Questions and Answers;

ICH E18 Guideline for Genomic Sampling and Management of Genomic Data

ICH guidelines applicable China

NMPA

Nov. 3, 2021

2

Technical Guidelines for Detecting Minimal Residual Diseases in Clinical Trials for Chronic Myeloid Leukemia Drugs

In force

CDE

Nov. 11, 2021

3

Technical Guidelines for Clinical Trials for Generic Oral Inhalants with Overseas Marketing Authorization and Without Marketing Authorization in China

In force

CDE

Nov. 19, 2021

4

Technical Guidelines for the Application of Minimal Residual Diseases in the Clinical Trials for Multiple Myeloma

In force

CDE

Nov. 19, 2021

5

Guidelines for Clinical-Value-Oriented Clinical Research on Antineoplastic Drugs

In force

CDE

Nov. 19, 2021

6

Common CMC Issues and Relevant Technical Requirements in the Pre-NDA Meetings for Innovative Chemical Drugs

In force

CDE

Nov. 26, 2019

7

Technical Requirements for CMC Research on Chemical Solution for Inhalation

In force

CDE

Nov. 26, 2021

8

Guidance for Making Quality Agreement on Sub-contract Production of Medical Devices (Consultation Draft)

Draft

NMPA

Nov. 15, 2021

9

Guidance for Writing Annual Self-Assessment Reports on Medical Device Quality Management Systems (Consultation Draft)

Draft

NMPA

Nov. 15, 2021

10

Chinese Translation of ICH Q3C (R8) Impurities: Guideline for Residual Solvents

Draft Chinese translation of   ICH guidelines applicable to China

CDE

Nov. 2, 2021

11

Technical Guidelines for Clinical Trials for Locally Applied and Locally Acting Drugs (Consultation Draft)

Draft

CDE

Nov. 12, 2021

12

Statistical Guidelines for Clinical Research on Rare Disease Drugs (Consultation Draft)

Draft

CDE

Nov. 18, 2021

13

Technical Guidelines for Clinical Research on Seasonal Influenza Virus Vaccines (Consultation Draft)

Draft

CDE

Nov. 19, 2021

14

Guidelines for Evaluating Immune-related Adverse Events in Antineoplastic Therapies (Consultation Draft)

Draft

CDE

Nov. 26, 2021

Welcome to contact BaiPharm for details of any foregoing regulations. We offer a full portfolio of China NMPA compliance consulting services. BaiPharm professionals have successfully carried out a great number of market entry projects of finished drugs, APIs, excipients and packaging materials.

Grace Wang
ChemLinked Regulatory Analyst
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