In Apr. 2021, China National Medical Products Administration (NMPA) and its subordinate body Center for Drug Evaluations (CDE) published a series of regulations on medical products including pediatric medicine and biosimilars. Here are the keynotes summarized by the ChemLinked BaiPharm team.
1. NMPA Releases Two Catalogs of Reference Listed Drugs
NMPA issued the 40th and the 41st Catalogs of Reference Listed Drugs (RLDs) on Apr. 9th and 27th, respectively. The 40th catalog included 67 medicines with different specifications, including Brinzolamide and Brimonidine Eye Drops; as for the 41st catalog, the products' total number is 55, featuring drugs such as Osimertinib Mesylate Tablets.
The RLDs are mainly selected from original foreign drugs on the Chinese market, original drugs marketed in the US, EU, or Japan but not in China, or the drugs produced locally in China by its original patent owner.
2. NMPA Changes Two Prescription Drugs' Classification to OTC Drugs
NMPA moved Guifu Dihuang Wan and Fufang Banlangen Keli (both are traditional Chinese medicines) from prescription drugs to Over-the-Counter drugs (OTC) drugs on Apr. 13th and 27th, respectively. The authority required the two drugs' MAHs (marketing authorization holders) to submit supplemental applications to provincial drug regulators for revising the medication package inserts. MAH shall also notify relevant medical institutes and drug distributors of the revised content. The two drugs will probably see a rise in sales volumes since the prescription-to-OTC switch makes them accessible at drug retailers, not merely at hospitals.
3. NMPA Requires Package Insert Revision for 22 Drugs
In April, NMPA announced requirements for revising package inserts and labels for 22 drugs, including Aamikacin Injection, Cefuroxime, Tramadol Hydrochloride and Paracetamol, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution.
The authority asked relevant MAHs to submit supplemental applications to CDE or provincial drug regulators in due time for revising package inserts. MAHs shall change the products' inserts and labels in nine months since the applications got on file to ensure safety in medical use.
4. NMPA Accepts Applications for Protecting Two Traditional Chinese Medicines
NMPA took two traditional Chinese medicines (TCMs) under protection this month, which means the formulation and manufacturing techniques of the two products will be protected by patent.
Application | Product Name | Manufacturer | Acceptance Date |
First-time protection | Enteric capsules made from five herbs, including bitter ginseng | Beijing Coway Pharmaceutical Co., Ltd | |
Protection renewal | Soft capsules for promoting blood circulation and relieving pain | Hubei Huihaixikang Pharmaceutical Co., Ltd |
5. NMPA Announces Three Supplemental Methods for Testing Drugs
On Apr. 1, NMPA published instructions on three supplemental methods for examining drugs:
High-performance liquid chromatography (HPLC) for testing abietic acid in Gentongping Tablets, a TCM for promoting blood circulation and reduce pain.
HPLC for testing Pseudoginsenoside F11 in Wuji Baifeng Wan, a TCM for replenishing strength and blood, regulating menstruation and arresting excessive leukorrhea.
HPLC and mass spectrometry (MS) for testing Pseudoginsenoside F11 in Xiaomishuan, a TCM for treating gynecological disorders such as vaginitis.
6. NMPA Publishes Five Guidelines on Technical Reviews for Medical Product Applications
On Apr. 15, NMPA issued five guidelines to notify relevant medical product applicants of how to prepare their application dossiers.
Guidelines on Technical Reviews for Applications for Revising the Medical Package Inserts of Companion Diagnostic Reagents for Antineoplastic Drugs
Guidelines on Technical Reviews for the Registration of Real-time Fluorescent PCR (Polymerase Chain Reaction) Analyzer
Guidelines on Technical Reviews for the Registration of Rotavirus Antigen Test Kit
Guidelines on Technical Reviews for the Registration of Nucleic Acid Test Kit for GBS (Group B Streptococci)
Guidelines on Technical Reviews for the Registration of Parvovirus B19 IgM/IgG Antibody Test Kit
7. NMPA Issues Principles of Classifying Recombinant Collagen Medical Products
On Apr. 15, NMPA published Principles of Classifying Recombinant Collagen Medical Products. The document stated how to supervise these products according to their characteristics.
(1) Recombinant collagen medical products won' t be supervised as medical devices if they don' t belong to "medical devices" as defined in the Regulations on the Supervision and Administration of Medical Devices.
(2) Medical product, if accords with the definition of "drug-device combination products", shall register as drugs if their functions are primarily pharmacological; otherwise, they shall register as medical devices if they mainly function as devices.
(3) Recombinant collagen medical products shall register as medical devices if they fit into the definition of "medical devices" and are free of drug substances with pharmacological functions. Furthermore, the products will be managed under Class 2 or 3 according to their specific functions.
8. CDE Consults on Technical Guidelines for Bioequivalence Studies on 17 Drugs
On Apr. 12, CDE published the consultation drafts of technical guidelines on BE (bioequivalence) studies for 17 drugs, including Lercanidipine Hydrochloride Tablets, Erlotinib Hydrochloride Tablets, Ebastine Tablets, Simvastatin Tablets and Ezetimibe Tablets.
The consultation guidelines indicate that the authority, while encouraging the development of generic drugs, is also keeping an eye on regulating their BE studies. In addition, generic drugs have the chance to enter the national procurement list only after proving they are on par with the RLDs (reference listed drugs) in BE studies.
9. CDE Publishes Two Guidelines on Clinical Trials of Biosimilars
On Apr. 22, CDE issued two guidelines on clinical trials, one for biosimilars of Pertuzumab Injections, the other for generic biologics of Tocilizumab Injections. The documents give guidance on the design and endpoints of clinical trials as part of the regulator's efforts to promote the R&D of biosimilars.
10. CDE Consults on Technical Guidelines on Pediatric Clinical Trials
On Apr. 13, CDE asked for public comments for its consultation draft of Technical Guidelines on Clinical Trials of Improved Chemical Drugs for Children. The draft, tailored to the growth characteristics of children, is meant to back the development of improved pediatric drugs in response to the clinical needs of pediatrics in China.
11. CDE Consults on Technical Guidelines on ADHD Clinical Trials
On Apr. 22, CDE began soliciting public opinions for its consultation draft of Technical Guidelines on the Clinical Trials of ADHD (Attention Deficient and Hyperactivity Disorder). The Guidelines mainly applies to innovative drugs developed in China for treating ADHD. The document focuses on advising the design of confirmatory clinical trials in key points such as selecting subjects from child patients with ADHD.
12. CDE Consults on Adding Pediatric Dosing Information to Drug Labeling
On Apr. 26, CDE took another step in regulating drugs that are applicable to children – consulting the Second List of Opinions on Revising the Package Inserts of Marketed Drugs for Adding Pediatric Dosing Information. The regulator intends to put the opinions into action on six antineoplastic drugs: Cisplatin, Ifosfamide, Mesna, Azathioprine, Asparaginase and Vindesine. The added information would include pediatric indications, usage & dosage and adverse reactions.
13. CDE Issues Guidelines on Real World Data for Generating Real World Evidence (Trial)
On Apr. 15, CDE released and started to implement the Guidelines on Real World Data for Generating Real World Evidence (Trial). The document is a supporting document for CDE's previous Guidelines on Real-World Evidence Supporting Drug Research, Development and Review (Trial), and specified requirements and advice for real world data (RWD) in aspects including RWD's source, evaluation, management, standard, safety compliance, quality assurance and applicability.
In addition, South China's Hainan Province has a pilot program that permits international medical products to generate and utilize RWD for quicker market access into the Chinese mainland. If you have any interests, please read our article "Clinical Real-World Data Pilot Program: Fast-Track Entry Pathway into China."
14. CDE Consults on Technical Guidelines on Testing Minimal Residual Diseases in the Clinical Trials of Drugs for Multiple Myeloma
On Apr. 22, CDE consulted on Technical Guidelines on Testing Minimal Residual Diseases (MRD) in the Clinical Trials of Drugs for Multiple Myeloma (MM). The Guidelines states requirements for testing MRDs through cytological and molecular methods.
CDE says the Guidelines are only for reference in the development and application of innovative drugs for MM. The regulator also suggests referring to other technical guidelines, including those issued by ICH (The International Conference for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use).
15. CDE Implements Technical Guidelines for CMC Changes of Marketed Traditional Chinese Medicines (Trial)
On Apr. 2, CDE released and started to implement Technical Guidelines for CMC (Chemistry, Manufacturing and Controls) Changes of Marketed TCMs (Traditional Chinese Medicines) (Trial). The Guidelines covers change items in manufacturing techniques, excipients in the formation of finished drugs, specification or package specification, registration standard, packaging materials & containers, expiration date, storage conditions and manufacturing site.
16. CDE Consults on Technical Guidelines on CMC Studies on TCM Compounds
On Apr. 26, CDE presented its consultation draft of Technical Guidelines on CMC Studies on TCM Compounds Administered as Ancient China's Classical Prescriptions. Ancient China's Classical Prescriptions refer to prescriptions recorded in ancient TCM books and are still widely used today with specific efficacy and distinct clinical advantages.
The TCM compounds managed as the classical prescriptions should register under the TCM Class 3.1. Considering the characteristics of TCM Class 3.1, the Guidelines gives requirements on the ingredients, TCM Yinpian (slices), reference products, manufacturing, quality studies and standards, correlational studies and product's stability.
For more details of the documents mentioned above or any other pharmaceutical regulations in China, feel free to consult BaiPharm through info@baipharm.com.
