Medical Policies Weekly ( Issue 20，2020）
A. The NMPA and the CDE issued multiple drafts for comments.
1、Guidelines for Real World Data Used to Generate Real World Evidence (Draft for Comments) provides specific requirements and instructional suggestions for real world data from such aspects as definition, sources, evaluation, governance, standards, safety compliance, quality assurance, and applicability of real world data, etc. The contents of the guidelines include introduction, sources and status quo of real-world data, evaluation of applicability of real-world data, real-world data governance, compliance of real-world data, communication between safety and quality management system as well as regulators, and attachments.
2、Technical Guidelines for Clinical Pharmacokinetics Study on Therapeutic Protein Drugs (Draft for Comments) aims to focus on the differences of pharmacokinetic characteristics between protein drugs and traditional small molecule drugs and to specify key points to be considered in the evaluation of clinical pharmacokinetics of therapeutic protein drugs. Among them, the research content introduces the key issues to be considered during the clinical pharmacokinetic study of therapeutic protein drugs; in the section of biological analysis, the commonly used analytical methods and characteristics of therapeutic protein drugs are introduced.
3、Technical Guidelines for Model-Guided Drug Development (Draft for Comments) aims to propose general considerations for model-guided drug development and on the basis of documentations about relevant technical requirements, both domestic and overseas, to emphasize on elaborating the philosophy and general principles of model-guided drug development with the main contents including overview, basic concepts, application of model analysis in drug development, sources and quality of data used for model analysis, implementation of model analysis and regulatory considerations.
4、Technical Guidelines for the Study on Population Pharmacokinetics (Draft for Comments) aims to propose suggestions for population pharmacokinetics (popPK) study and mainly applies to population pharmacokinetics in clinical trials of innovative drugs and biosimilar drugs with the contents mainly including five parts, namely overview, application scope, clinical study design, data analysis and quality control, together with two appendices which are respectively for analysis report and glossary.
5、Technical Guidelines for Bioequivalence Study on Narrow Therapeutic Index Drugs (Draft for Comments), with the main content including overall design of study, statistical analysis method, results documentation and other considerations, suggests that the bioequivalence study on narrow-therapeutic index drugs should adopt a completely repeated cross-over design to obtain intra - individual variability of reference preparations and tested preparations, and should further evaluate bioequivalence of tested preparations and reference preparations from three aspects simultaneously: 1)adopting reference-scaled average bioequivalence (RSABE); 2) adopting average bioequivalence; 3) comparing the intra-individual standard deviation of tested preparations and reference preparations.
6、Guidelines for Research and Verification of Sterilization and Aseptic Processing of Chemical Injection (Draft for Comments) emphasizes on stating the research and verification of common sterilization/ aseptic processing of injection, namely terminal sterilization process and aseptic production process based on moist heat sterilization, aiming to promote research and evaluation of chemical injection at the present stage and mainly applies to research and verification of sterilization /aseptic processing of aseptic injections in the registration and application process of applying for being listed and undergoing changes after listing.
7、Requirements for Application Materials for Selection of Chemical Generic Reference Preparations (Draft for Comments), formulated in line with the implementation of the NMPA's Announcement on the Procedures for Selection and Determination of Chemical Generic Drugs Reference Preparations (No. 25 of 2019), aims to better serve the applicants and further improve quality and efficiency of selection of reference preparations.
8、The Catalogue of Chemical Generic Reference Preparations (the 32nd batch) (Draft for Comments): according to Announcement on the Selection and Determination Procedures for Chemical Generic Drugs Reference Preparations issued by the NMPA on March 28, 2019 (No. 25 of 2019), the CDE organized the selection of the thirty-second batch of reference preparations and solicited public opinions.
9、Interim Provisions on the Administration of Domestic Agents of Overseas Pharmaceutical Marketing License Holders (Draft for Comments) aims to further strengthen the supervision and administration of the overseas pharmaceutical marketing license holders and regulates the behaviors of their domestic agents.
10、A series of documents concerning conditions of qualification recognition and specifications of inspection work of pharmaceutical inspection institutes include Qualification Recognition and Inspection Work Specifications of Pharmaceutical Inspection Institutes, Inspection Work Specifications of TCM, Work Specifications of Chemical Medicines, Work Specifications of Biological Products, Work Specifications of Pharmaceutical Auxiliary Materials and Pharmaceutical Packaging Materials and Work Specifications of Drug Safety Evaluation and solicited public opinions.
B．The CDE issued Guidelines for Clinical Trials of Biosimilars to Adalimumab Injections and the other formal guideline.
In order to cooperate with the implementation of the newly revised Provisions for Drug Registration and to provide drug R&D with technical standards for reference, and after solicitation of public opinions in the early stage, the CDE issued two guidelines on August 3rd: Guidelines for Clinical Trials of Biosimilars to Adalimumab Injections and Guidelines for Clinical Trials of Biosimilars to Bevacizumab Injections, to guide the clinical research and development of biosimilars to Adalimumab injections and Bevacizumab injections in China and the guidelines shall be implemented as of the promulgation date.
C．The CDE issued Filing Procedures and Requirements for the Sub-packaging of Drugs Manufactured Abroad.
C．The CDE issued Filing Procedures and Requirements for the Sub-packaging of Drugs Manufactured Abroad.
The CDE issued Filing Procedures and Requirements for the Sub-packaging of Drugs Manufactured Abroad, applicable to the drugs which complete production process of the final preparation out of borders and change big packing specifications into small packing specifications within the territory, or among others, to the outer packing, instruction placement and label pasting of drugs which complete inner packing and the drugs manufactured abroad applying for sub-packaging which has obtained drug registration certificate. The document shall be implemented as of the promulgation date.
Before the implementation of Provisions for Drug Registration (SAMR Order No.27), the sub-packaging of imported drugs has obtained the supplementary application approval of drugs and the approval number shall remain valid within the validity period. After the implementation of Provisions for Drug Registration, if the packaging specifications of the outer packing used for drug sub-packaging have obtained Import Drug License (CFDA Approval Certificate) and are within the validity period, the sub-packaging of drugs manufactured abroad may be filed with directly. The drug approval number shall not be approved or issued for the sub-packaging of drugs manufactured abroad in accordance with the filing procedures and requirements.
D． The National Healthcare Security Administration of The People's Republic of China (the NHSA) issued Work Plan for the Adjustment of Drugs Catalogue for National Medical Insurance 2020 (Draft for Comments).
D． The National Healthcare Security Administration of The People's Republic of China (the NHSA) issued Work Plan for the Adjustment of Drugs Catalogue for National Medical Insurance 2020 (Draft for Comments).
In accordance with the Interim Measures for the Administration of Use of Drugs Covered by the Basic Medical Insurance and in combination with the priorities of the administration of drugs catalogue for national medical insurance, the NHSA has studied and drafted Work Plan for the Adjustment of Drugs Catalogue for National Medical Insurance 2020 (Draft for Comments) , and solicited public opinions. According to the draft for solicitation of comments, the scope of the adjustment for drug catalogues in 2020 includes: western medicines and Chinese patent medicines outside the catalogue, covering seven cases of drugs to be added including the drugs used for treatment of COVID-19 related respiratory diseases; western medicine and Chinese patent medicine inside the catalogue, covering the scope of drugs out of the catalogue and drugs in the adjustment for standard of payment; others include inclusion of qualified TCM readymade slices in the adjustment scope according to regulations, improvement in the notes on the drug catalogues, standardization of drug name and dosage forms, and appropriate adjustment of the classification of drug category A and B, classification structure of the catalogues, remarks and other contents. The working procedure for drugs catalogue for national medical insurance 2020 is divided into five stages: preparation (July to August 2020), enterprise applications (August to September 2020), expert review (September to October 2020), negotiated bidding (October to November 2020), and results announcement (November to December 2020).
