To help all colleagues stay abreast of the latest developments in national pharmaceutical policies and better align them with their respective work, we have compiled below the policies, guiding principles, and official notices issued by relevant national authorities in recent months (June and July):

　　(1) Consistency Evaluation of Generic Drugs—General Requirements for the Registered Batch Production Scale of Chemical Generic Drugs (Trial)

　　The CDE has officially released the General Requirements for Registration-Scale Production of Chemical Generic Drugs (Trial), which sets forth clear specifications for the registration-scale production volumes of oral dosage forms, injectables, transdermal patches, and topical creams, among others. The trial version is essentially identical to the previously published draft for public comment. The trial version underscores that the quality of registration-scale batches must be consistent with that of commercial-scale products and emphasizes that the manufacturing sites, down to the specific production lines and equipment configurations, used for registration-scale production should be aligned with those planned for commercial-scale production.

　　(2) Notice of the National Medical Products Administration on the Publication of the Catalogue of Reference Listed Drugs for Generic Medicines (Batch 15) (No. 49 of 2018)

　　The CNDA has released the 15th batch of the Reference Listed Drug Catalog for Generic Medicines, comprising 15 products, including two supplementary reference listed drugs—clarithromycin sustained-release tablets—and 13 newly added products, such as selegiline hydrochloride tablets and olmesartan medoxomil/hydrochlorothiazide tablets.

　　(3) Registration Reform—Public Notice of Drug Registration Applications Proposed for Inclusion in the Priority Review Procedure (Batch 29)

　　This round of priority review includes 12 new-drug marketing applications, 2 new-drug clinical trial applications, and 30 generic-drug marketing applications. The list features 12 products that have been transferred back to domestic production from parallel manufacturing lines, including Dongyang Guang’s olmesartan medoxomil tablets and esomeprazole enteric-coated capsules, Huahai’s entecavir tablets, Haizheng Pfizer’s irbesartan hydrochlorothiazide tablets, and Changzhou Pharmaceutical’s rosuvastatin calcium tablets, among others.

　　(4) Clinical Self-Inspection — Announcement of the National Medical Products Administration on the Status of Registration Applications for Self-Inspection and Verification of Clinical Trial Data for Drugs (No. 30, 2018)

　　The National Medical Products Administration has decided to conduct clinical trial data verification on 192 newly received drug registration applications for which clinical trials have been completed and which seek approval for manufacturing or import: these include 19 new drugs, such as Calcium Leucovorin Injection from Shanghai Huilun; 153 generic drugs, such as Sofosbuvir Tablets from Beijing Kain; 7 imported drugs, such as Edoxaban Mesylate Tablets from Daiichi Sankyo; 8 re-registration applications for imported products, including Recombinant Human Coagulation Factor VIII for Injection from Pfizer; and 5 supplementary applications, such as Nadroparin Calcium Injection from Hebei Changshan Biochemical.

　　(5) Announcement of the On-site Inspection Plan for Clinical Trial Data of Drugs (No. 19)

　　It is planned to conduct on-site inspections of clinical trial data for 31 drug products, including palbociclib capsules, nafamostat mesylate for injection, and p-toluenesulfonamide injection.

　　(6) Notice of the General Office of the Ministry of Industry and Information Technology on Issuing the Key Work Arrangements for the 2018 Special Campaign on “Three Goods” in the Consumer Goods Industry

　　The report states that local authorities should be guided in developing centralized production bases for small-volume (shortage) drugs, with 10 such drugs to be added to ensure stable production and supply. In addition, pharmaceutical companies will be supported in conducting evaluations of the quality and therapeutic equivalence of generic drugs.

　　(7) Announcement of the National Medical Products Administration on the Publication of the “2017 Annual Drug Inspection Report” (No. 32 of 2018)

　　In 2017, a total of 751 drug inspections were conducted, covering 751 enterprises and product varieties, including 52 on-site inspections of drug registration manufacturing sites, 12 inspections for bioequivalence evaluation, and 428 follow-up GMP inspections. In 2017, issues related to data reliability—such as falsification of submission documents and lack of data traceability—were no longer prominent; instead, there were more frequent findings concerning compliance with GMP requirements prior to marketing approval. This indicates that companies’ quality management systems during the drug development process remain relatively weak and that insufficient attention is paid to GMP compliance.

　　(8) Notice of the National Medical Products Administration on Matters Related to the Conduct of the 2018 National Drug Surveillance Inspection (No. 35 of 2018)

　　Based on issues identified in the 2017 national drug inspections, random sampling inspections, adverse reaction monitoring, and complaint/report handling, the “2018 Drug Follow-up Inspection Plan” was formulated. This plan covers 201 pharmaceutical manufacturing enterprises, including 38 enterprises that were found to have numerous problems during the 2017 national random sampling inspections, 40 vaccine and biological product manufacturers, 28 blood products manufacturers, 15 manufacturers of anesthetics, psychotropic drugs, and precursor chemicals for drug manufacture, 60 manufacturers of newly approved generic injectable formulations, and 20 enterprises subject to special inspections.

　　(9) Notice on the Publication of the “Statistical Guidance Principles for Bioequivalence Studies (Draft for Comments)” and the “Technical Guidance Principles for Bioequivalence Studies of Highly Variable Drugs (Draft for Comments)”

　　The draft for public comment states that, for highly variable drugs with a favorable safety profile and a wide therapeutic window, the conventional bioequivalence criteria may be appropriately relaxed by employing a partially or fully replicated crossover design and applying the reference-scaled average bioequivalence (RSABE) approach. In special circumstances—for example, with long-half-life drugs—a parallel-group design may be used.

　　(10) The National Medical Products Administration Elected as a Member of the ICH Governing Council

　　At the first 2018 meeting of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), held in Kobe, Japan, on June 7, the China National Medical Products Administration was elected as a member of the ICH Management Committee.