Editor's Note: The monthly recap is a brief collection of recently-issued drug laws, regulations and policies in China, especially those issued by National Medical Products Administration (NMPA) and its affiliating office Center for Drug Evaluation (CDE).
1. NMPA Releases the 44th Batch of Reference Listed Drugs
On Aug. 16, NMPA published the 44th batch of reference listed drugs (RLD). The batch covers 54 drug products, such as N.V. Organon's Testosterone Undecanoate Soft Capsules and Pfizer's Tafamidis Meglumine Soft Capsules.
RLDs are selected by NMPA's generic drug quality and efficacy consistency evaluation expert panel. They are products to which new generic versions are compared to show that they are bioequivalent.
The English version of the 44th batch of RLDs has been uploaded to BaiPharm Database.
2. SAMR to Enforce New Rules for Medical Device and IVD Reagent Registration/Filing
On Aug. 26, China State Administration for Market Regulation (SAMR) promulgated Administrative Measures for Medical Device Registration and Filing and Administrative Measures for IVD Reagent Registration and Filing, both set to take effect on Oct. 1, 2021.
The two regulations specified the requirements for registration application/filing documentation, conditions for exempting clinical evaluation/trials, etc. For more details, please refer to ChemLinked BaiPharm article.
In this September, NMPA released the List of Medical Devices Exempted from Clinical Evaluation and the List of In Vitro Diagnostic Reagents Exempted from Clinical Trials, so that applicants can search in the lists to see if their products are eligible for exemption. For more details, please click here.
3. NMPA Announces Four Rx-to-OTC Switches
In Aug. 2021, NMPA granted four formerly prescription (Rx) drugs over-the-counter (OTC) status. Marketing authorization holders (MAHs) of the drugs shall submit supplemental applications to provincial medical products administrations for labeling changes. The MAHs shall also notify the changes to relevant healthcare institutions and suppliers. The English version of China's OTC catalog will be uploaded to BaiPharm Database.
Four Rx-to-OTC Switches Announced by NMPA in Aug. 2021 | |||
Drug Name | Strength | OTC Class | |
1 | Radix Codonopsis, Astragalus and Schisandra Chinensis (Turcz.) Baill. Capsule (Pinyin: Shenqi Wuweizi Jiaonang) | 0.25g/capsule | Class A |
2 | Pediatric Seven-Herb-Tea Granules (Pinyin: Xiao'er Qixingcha Keli) | 3.5g/pack | Class A |
3 | Gynaecological Health Capsules (Pinyin: Fukang Jiaonang) | 0.4g/capsule | Class A |
4 | Radix Codonopsis and Astragalus Chewable Tablet (Pinyin: Shenqi Jujue Pian) | 3.6g/tablet | Class A |
4. NMPA Adds Six Substances to the List of Precursor Chemicals
According to an NMPA announcement on Aug. 25, six substances are added to the Catalog and Classification of Precursor Chemicals, an appendix to the Provisions on the Administration of Precursor Chemicals. From Sept. 20, the six substances' manufacturing, supply, purchase, transport, import and export shall comply with regulations on non-medical precursor chemicals.
Six Substances Added to the List of Precursor Chemicals | |||
Substance | CAS | Precursor Chemical Class | |
1 | Methyl 3-oxo-2-phenylbutanoate (MAPA) | 16648-44-5 | Class II |
2 | 3-oxo-2-phenylbutanamide (APAA) | 4433-77-6 | Class II |
3 | 3-(Benzo[d][1,3]dioxol-5-yl)-2-methyloxirane-2-carboxylic Acid | 2167189-50-4 | Class II |
4 | Methyl 3-(1,3-Benzodioxol-5-yl)-2-methyl-2-oxiranecarboxylate | 13605-48-6 | Class II |
5 | Phenylacetonitrile | 140-29-4 | Class III |
6 | Gamma-Butyrolactone | 96-48-0 | Class III |
5. CDE Consults on Regulations on Post-Approval Changes to Overseas-Manufactured Drugs
On Aug. 30, CDE released Procedures and Requirements for Overseas-Manufactured Drug's Post-Approval Filing Changesfor public opinions.
Procedures for Overseas-Manufactured Drug's Post-Approval Filing Changes in China (draft in consultation) |
1. The applicant submits electronic documents to file an application at NMPA's system, then the applicant will get a filing number after the system receives all the documents. |
2. While submitting electronic documents online, the applicant shall also send a collection of paper documents to CDE. |
3. NMPA makes the filing information public within five days after the applicant completes the filing. |
4. CDE completes reviewing the on-file documents within 60 days after the filing task enters CDE's system. |
5. CDE shall check the previous filing information of the drug product when reviewing the relevant supplemental/re-registration applications. |
6. Guidelines Released by NMPA and CDE
In Aug. 2021, NMPA and CDE released a total of 27 drug/device guidelines.
If you need more details of the regulations mentioned above, welcome to contact us via contact@chemlinked.com.
