Monthly Recap: China Pharmaceutical Regulatory Updates | January 2022

Editor's Notes: Monthly recap is a collection of recent pharmaceutical laws, regulations, and policies in China, mainly 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. Pilot Online Sales of Prescription Drugs in Shenzhen

The National Development and Reform Commission and the Ministry of Commerce rolled out the measures for easing market access in Shenzhen, Guangdong province. One step is to permit prescription drugs to be sold online on a trial basis.¹

2. National Insulin Procurement to Start in May

According to the State-led Joint Drug Procurement Office, the volume-based procurement (VBP) of insulin will start in May this year.² The exact date will be revealed by local procurement offices later. Read more about insulin VBP in China.

3. Two Rx-to-OTC Switches

On Jan. 25, China NMPA granted OTC status to two traditional Chinese medicines: Honghua Xiaoyao Tablets (Honghua Xiaoyao Pian) and Anti-inflammatory Pudilan Tablets (Pudilan Xiaoyan Pian).³ Search for OTC drugs in BaiPharm Database.

4. The 50th Batch of RLDs

On Jan. 11, China NMPA released the 50th batch of reference listed drugs (RLDs). This batch covers 64 drugs, including LEO Pharma's Alfacalcidol Drops and Novartis' Nelarabine Injection.⁴

RLDs are reference products with which generic drugs must be consistent in quality and efficacy. The Catalog of RLDs has been updated in BaiPharm Database.

5. 221 Medical Devices Receive Marketing Approval

On Jan. 17, China NMPA unveiled the list of 221 medical devices approved in December 2021, including Boston Scientific Corporation's Percutaneous Access Needle and HydroDam Cannula System's HydroDam Cannula System.⁵

6. Three Industry Standards for Medical Devices

On Jan. 18, China NMPA issued three medical device standards, including requirements for safety and performance of respiratory humidifiers.⁶

7. Guidelines

No.	Guidelines	Authority	Release
1	Guidelines for Pre-approval Inspection of Drug-Device Combination Products Mainly Functioning as Medical Devices	NMPA	Jan. 17
2	Guidelines for Pre-approval Inspection of the Qualitative and Quantitative Research and In Vitro Release Research on Drug-Device Combination Products Mainly Functioning as Medical Devices	NMPA	Jan. 17
3	Technical Guidelines for Revising Safety Information in the Package Inserts of Approved Traditional Chinese Medicines (Trial)	NMPA	Jan. 7
4	Technical Guidelines for Research on Testing Samples for the Toxicology Studies on New Traditional Chinese Medicines (Trial)	CDE	Jan. 7
5	Guidelines for Application Documents for Medical Theories of New Compound Traditional Chinese Medicines (Trial)	CDE	Jan. 7
6	Writing Guidelines for the Package Inserts of Traditional Chinese Medicines with Classic Ancient Prescriptions (Trial)	CDE	Jan. 7
7	Technical Guidelines for Clinical Risk Management Plan for the Marketing Authorization Applications of CAR-T Therapeutic Products	CDE	Jan. 29
8	Guidelines for Designing Clinical Trials for Biosimilars of Basal Insulins Given Single Dose Daily	CDE	Jan. 28
9	Guidelines for Designing Clinical Trials for Liraglutide Used in Weight Control	CDE	Jan. 28
10	Guidelines for Designing Clinical Trials for Biosimilars of Teriparatide Injection	CDE	Jan. 26
11	Guidelines for Statistical Methods for Centralized Monitoring of Clinical Trials for Drugs (Trial)	CDE	Jan. 21
12	Guidelines for Designing Clinical Trials for Recombinant Human Granulocyte-colony Stimulating Factor (rhG-CSF) for Preventing Febrile Neutropenia After Chemotherapy (Trial)	CDE	Jan. 20
13	Guidelines for Designing Clinical Trials for Biosimilars of Cetuximab Solution for Infusion (Trial)	CDE	Jan. 20
14	Technical Guidelines for Therapeutic Pediatric Drugs for Pulmonary Arterial Hypertension	CDE	Jan. 12
15	Technical Guidelines for Therapeutic Drugs for Pulmonary Arterial Hypertension	CDE	Jan. 12
16	Technical Guidelines for Clinical Trials for New Drugs of Monoclonal Antibodies Against Rabies Virus	CDE	Jan. 10
17	Technical Guidelines for Randomization in Clinical Trials for Drugs (Trial)	CDE	Jan. 7
18	Technical Guidelines for Research on Human Bioavailability and Bioequivalence of Innovative Drugs	CDE	Jan. 7
19	Technical Guidelines for Clinical Pharmacokinetic Studies on Improved Controlled-release Drugs	CDE	Jan. 7
20	Technical Guidelines for Drug Dependence Research	CDE	Jan. 7
21	Technical Guidelines for Samples Used in Toxicological Studies on New Traditional Chinese Medicines (Trial)	CDE	Jan. 7
22	Technical Guidelines for Clinical R&D of Rare Disease Drugs	CDE	Jan. 6
23	Guidelines for Designing Clinical Trials for Prophylactic Drugs for Antineoplastic-Drug-induced Nausea	CDE	Jan. 6
24	Technical Guidelines for Pharmacokinetic Studies in Patients with Impaired Renal Function (Trial)	CDE	Jan. 6
25	Writing Guidelines for Clinical Risk Management Plans (Trial)	CDE	Jan. 6
26	Technical Guidelines for Pre-approval Meetings Under the Traditional Chinese Medicine Review System with Evidence Based on Theory, Human Use Practice and Clinical Trials (Consultation Draft)	CDE	Jan. 5
27	Technical Guidelines for Clinical Trials for Direct Acting Anti-hepatitis C Virus Drugs	CDE	Jan. 5
28	Technical Guidelines for Clinical Trials for Drugs Treating Ulcerative Colitis	CDE	Jan. 5
29	Technical Guidelines for Clinical Trials for Drugs Treating Crohn's Disease	CDE	Jan. 5
30	Technical Guidelines for Research on Food Effects During New Drug Development	CDE	Jan. 5
31	Guidelines for Data Management and Statistical Analysis Plans for Drug's Clinical Trials	CDE	Jan. 4
32	Guidelines for Applying Patient Reported Outcomes into the Clinical R&D of Drugs (Trial)	CDE	Jan. 4
33	Technical Guidelines for Research on Crystal Structures of Generic Drugs (Trial)	CDE	Jan. 4
34	Technical Writing Guidelines for Reference Safety Information in Investigator's Brochure	CDE	Jan. 4

Contact BaiPharm for details of any above-mentioned 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.