Editor's Notes: Monthly recap is a collection of China's pharmaceutical laws, regulations, policies, and standards recently 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);
National Joint Drug Procurement Office;
Chinese Pharmacopoeia (ChP) Commission.
The following are the regulatory updates in Mar. 2023.
China NMPA Grants OTC Status to Two Former Prescription Drugs
China NMPA Releases Two RLD Lists
China NMPA Releases RLD Adjustment Procedures
China CDE Trials Work Procedures for Expediting the Review of Innovative Drug’s Marketing Authorization Application
China CDE Consults on Dossier Requirements for Moving the Manufacturing Site to China
NMPA and CDE Issue or Adopt Pharmaceutical Guidance Documents
Chinese Pharmacopoeia Commission Consults on Draft Standards
1. China NMPA Grants OTC Status to Two Former Prescription Drugs
On Mar. 13, NMPA announced the approval of Rx-to-OTC switches of Chaihuang Oral Solution and E'jiao Capsules. China’s OTC Drug Catalog now covers 5,045 drugs. View the full catalog at BaiPharm Database.
Related: China Updates Documentation Requirements for Rx-to-OTC Switch Applications
2. China NMPA Releases Two RLD Lists
On Mar. 14 and 15, NMPA released the 65th and the 66th lists of reference listed drugs (RLDs), with 67 and 36 new RLDs respectively. China’s RLD list now includes 5,722 drugs. View the full catalog at BaiPharm Database.
3. China NMPA Releases RLD Adjustment Procedures
On Mar. 24, NMPA issued the Procedures for Adjusting Reference Listed Drugs (RLDs) of Chemical Generic Drugs (Trial) with immediate effect.
Drugs in the RLD Catalog with any of the below three conditions are subject to adjustment:
1) The drug has been withdrawn from the market due to safety or efficacy reasons.
2) The drug is not encouraged to be copied because it, even though after technological improvement, still cannot meet the criteria in the current Chinese Pharmacopoeia or the technological requirements for drug review.
3) Other conditions: after being evaluated, the drug is deemed not fulfilling the RLD criteria.
Check out the procedures at BaiPharm’s report “China May Delist Ineligible RLDs of Chemical Generic Drugs”.
4. China CDE Trials Work Procedures for Expediting the Review of Innovative Drug’s Marketing Authorization Application
On Mar. 31, CDE released the CDE Work Rules for Expediting the Review of Innovative Drug’s Marketing Authorization Application (Trial) (hereafter referred to as the Rules) with immediate effect. The Rules applies to
innovative drug specially for pediatric patients;
innovative drug for treating rare disease;
innovative drug with Breakthrough Therapy Designation;
However, the Rules is NOT applicable to drugs for special approval.
To accelerate the review, applicant of the above drugs should apply for the expedition after completing the exploratory clinical trial and having sufficient conditions to conduct the confirmatory clinical trial, before the marketing authorization. Applicants who seek conditional approval can apply for expedition before completing the exploratory clinical trial. The applicant should also apply for Priority Review while applying for marketing authorization.
The CDE-applicant communication period for the expedition should be completed within 30 workdays, and the review for the expedited application within 130 workdays.
Related: Expedited Programs for Drug Registration in China
5. China CDE Consults on Dossier Requirements for Moving the Manufacturing Site to China
On Mar. 23, China CDE released the draft of Dossier Requirements for Marketing Authorization Applications for Approved Imported (Chemical) Drugs With Manufacturing Sites Intended to be Transferred to China for public comments.
According to the draft, the application dossier should include the following documents.
A Simplified Table of Dossier Requirements for Marketing Authorization Applications for Approved Imported (Chemical) Drugs With Manufacturing Sites Intended to be Transferred to China (Draft) | |
Module 1 | Following the M4 Module 1: Administrative Information and Prescribing Information Required documents for special attention: - Copy of the certification documents and their appendices proving marketing authorization, including the drug import registration certificate, the approval document for supplemental application, the approval document for registration renewal, quality standards, a table specifying the manufacturing process, medication package inserts, etc. Reasons should be specified if no relevant documents under this item are provided. … |
Module 2 | Following the CTD format. The quality overall summary (QOS) should include a table showing the general comparison between the situations before and after the change of the manufacturing site, and the main results and conclusion of the studies comparing the pre- and after-change situations under each item. If there are associated changes apart from changes of MAH and the manufacturing site, studies on the other changes should also be summarized under each item. |
Module 3 | Following the CTD format. The applicant shall also pay attention to the following documents based on the specific situations of the manufacturing site transferred from overseas to China. 1) formulation and manufacturing process research documents; 2) API & excipient research documents; 3) Quality research & trial documents; 4) Research documents on packaging materials in direct contact with the drug; 5) Drug stability research documents; 6) Consideration for related changes. |
Module 4 | Except for oral dosage forms, the applicant should provide the safety trial documents of all drugs whose manufacturing are transferred from overseas to China to show the pre- and after-change comparison between the samples.
If CMC study is insufficient to prove the equivalence between the samples before and after the change, more non-clinical studies may be required, e.g., dosage form safety trial, toxicity trial for repeated doses, and/or non-clinical pharmacokinetic study. If non-clinical trial is required, the applicant should submit the documents in CTD format. If not required, the applicant has no need to submit the documents for this item. |
Module 5 | For drugs whose manufacturing site is transferred from overseas to China, the applicant can refer to the principle of generic drug’s equivalence evaluation—not doing in vivo study if the CMC study is sufficient to show the comparison.
For some drugs which cannot be proved to be equivalent to the previous situation after the manufacturing site changes, the applicant can consider comparing the equivalence through BE study, which may involve PK-BE, PD-BE, or clinical endpoint bioequivalence (CEP-BE) study. The requirements for in vivo BE study are consistent with those for the registration of class 4 chemical drugs.
For clinical endpoint equivalence study, the applicant shall submit clinical trial documents in CTD format. If in vivo study is not required, the applicant has no need to submit the documents for this item. |
6. NMPA and CDE Issue or Adopt Pharmaceutical Guidance Documents
7. Chinese Pharmacopoeia Commission Consults on Draft Standards
No. | Draft Standards | Type | Issued |
1 | Monograph of chemical drug product | 09/03/2023 | |
2 | Cefoperazone Sodium and Tazobactam Sodium for Injection (III) | Monograph of chemical drug product | 09/03/2023 |
3 | Cefoperazone Sodium and Tazobactam Sodium for Injection (III) | Monograph of chemical drug product | 09/03/2023 |
4 | General chapter | 14/03/2023 | |
5 | General chapter | 14/03/2023 | |
6 | Monograph of API | 14/03/2023 | |
7 | Acidum Linolcicum Vitamium E Soft Capsules/Two Vitamium Rutinum Tablets | Monograph of finished dosage form | 14/03/2023 |
8 | Monograph of chemical drug product | 14/03/2023 | |
9 | Monograph of TCM | 28/03/2023 | |
10 | Monograph of excipient | 28/03/2023 | |
11 | Monograph of excipient | 28/03/2023 | |
12 | Monograph of excipient | 28/03/2023 | |
13 | Monograph of API | 28/03/2023 | |
14 | Monograph of chemical drug product | 28/03/2023 |
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