Medical Policies Weekly (Issue 25,2020)
The Department of Comprehensive Affairs, Planning, and Finance Affairs of the NMPA and the General Office of the National Intellectual Property Administration issued Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial) (Draft for Comment).
In order to protect the legitimate rights and interests of the patentee, reduce the risk of patent infringement of generic drugs, encourage innovation in drug development and promote high-quality development of generic drugs, the Comprehensive Department of the NMPA and the General Office of the National Intellectual Property Administration jointly studied and drafted Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial) (Draft for Comment). The main contents of the implementation measures include: establishment of patent information registration platform for listed drugs in China, clarification of the scope of patent information registration platform for drugs, stipulation of the declaration system of patent application status for generic drug applicants, clarification of the time limit for the patentees or interested parties to raise an objection, establishment of a waiting period for the review and approval of chemical drugs, implementation of the classification for drug review and approval and greater incentives for patent challenges of generic drugs.
The CDE issued Announcement on Procedures for Re-registration Application for Drugs Manufactured Abroad, Requirements of Application Materials and Contents of Formal Examination.
The CDE issued Announcement on Procedures for Re-registration Application for Drugs Manufactured Abroad, Requirements of Application Materials and Contents of Formal Examination.
In accordance with the NMPA Announcement on Issues Pertaining to the Implementation of the Provisions for Drug Registration (No. 46 of 2020), and to promote the drafting and formulation of relevant supporting normative documents and technical guidelines, the CDE issued Procedures for Re-registration Application for Drugs Manufactured Abroad, Requirements of Application Materials and Contents of Formal Examination according to the deployment of the NMPA, released the announcement with the approval of the NMPA and the document shall enter into force as of October 1st,2020.
The CDE issued Technical Guidelines for Drug Interaction Studies (Draft for Comments).
The CDE issued Technical Guidelines for Drug Interaction Studies (Draft for Comments).
In order to encourage and guide enterprises to make rational R&D strategies in drug R&D, improve efficiency, avoid risks, and carry out timely and standardized drug interaction studies, the CDE issued Technical Guidelines for Drug Interaction Studies (Draft for Comments) and solicited public opinions. The guidelines aim to provide recommendations for the design and implementation of drug interaction studies. The main contents include overview, technical points of in vitro DDI studies, technical points of DDI clinical studies, requirements for report submission and recommendations for DDI information elaborated in the package insert, et., which are mainly applicable to chemical medicines and biological products as well as TCMs can be implemented by reference.
The CDE issued Technical Guidelines for Pharmaceutical Research and Evaluation of Gene Therapy Medicinal Products (GTMPs) (Draft for Comments).
The CDE issued Technical Guidelines for Pharmaceutical Research and Evaluation of Gene Therapy Medicinal Products (GTMPs) (Draft for Comments).
To regulate the development and pharmaceutical research of GTMPs, better guide the development of the industry and to meet the clinical demand for new treatment methods for rare and refractory diseases, the CDE drafted Technical Guidelines for Pharmaceutical Research and Evaluation of Gene Therapy Medicinal Products (GTMPs) (Draft for Comments). The main contents of the guidelines include nine parts: the first part mainly clarifies the background and preconditions of the formulation of the guidelines; the second and the third part clarify the scope of application and consideration of general principles of the guiding principles; from the fourth part to the eighth part, the pharmaceutical research requirements are put forward from such aspects as raw materials for production, manufacturing techniques, quality control, stability study and packaging system; the ninth part proposes general considerations of environmental safety for the particularity of GTMPs.
The CDE issued Basic Technical Requirements for Immunogenicity of Low-molecular-weight-heparin (LMWH) Generic Drugs (Draft for Comments).
The CDE issued Basic Technical Requirements for Immunogenicity of Low-molecular-weight-heparin (LMWH) Generic Drugs (Draft for Comments).
To improve technical standards for generic drug registration applications, the CDE organized the drafting of Basic Technical Requirements for Immunogenicity of Low-molecular-weight-heparin (LMWH) Generic Drugs (Draft for Comments). On the basis of domestic and foreign guidelines and technical literature, the technical requirements emphasize on discussing the main contents to be considered for immunogenicity assessment of low-molecular-weight heparins (LMWHs) and recommend some research methods; with the purpose of providing technical references for R&D of LMWHs generic products and research on post-marketing changes which may be affected by immunogenicity of the products, and promoting the current research and evaluation of generic products.
