Medical Policies Weekly (Issue 24,2020)
1、The CDE issued a statement on the acceptance requirements for clinical study report (CSR).
On November 12th, 2019, the NMPA issued Announcement on the Application of 15 ICH Guidelines Including E1: Extent of Population Exposure to Assess Clinical Safety: For Drugs Intended for Long-term Treatment of Non-Life-Threatening Conditions (No. 88 of 2019), and for new drug marketing applications accepted 6 months after the date of this Announcement, E3: Structure and Content of Clinical Study Reports and E3 Q & A (R1) are applicable.
On July 3rd, 2020, Guidelines for Acceptance and Reviews of Chemical Drug Registration (Trial) and Guidelines for Acceptance and Reviews of Biological Products Registration (Trial) were issued by the CDE as well as Announcement on Guidelines for Acceptance and Reviews of Drug Registration (Trial) released by the CFDA was abolished simultaneously. Among them, requirements for clinical study report (CSR) data was revised, that is: clinical study report should conform to the requirements of the relevant guidelines, clinical study report title page should provide the applicant for drug registration (signature and stamp), principal or coordinating investigators (signature), responsible or coordinating investigating unit name, head of the statistics (signature) and statistical unit name and other information required by the ICH E3; the appendix II of the clinical study report shall be provided with the signature of the sponsor's responsible medical specialist. Submission of sub-center reports is not required as compared with the previous guidelines for acceptance & review.
2、The CDE issued Guidelines for Novel Coronavirus Neutralizing Antibody Drug Application for Clinical Pharmaceutical Research and Technical Data Requirements (Trial).
2、The CDE issued Guidelines for Novel Coronavirus Neutralizing Antibody Drug Application for Clinical Pharmaceutical Research and Technical Data Requirements (Trial).
To actively respond to COVID-19 outbreak and accelerate novel coronavirus neutralizing antibody drug research and development, on September 9th, the CDE issued Guidelines for Novel Coronavirus Neutralizing Antibody Drug Application for Clinical Pharmaceutical Research and Technical Data Requirements (Trial) and it will take effect as of the promulgation date. The guidelines mainly include basic considerations, study on the raw material for production, study on production technology, structure confirmation and quality research, draft regulations for quality inspection and record of manufacturing verification of samples used in clinical trials, preliminary stability study, packaging materials and containers in direct contact with products, considerations of transient transfection or non-monoclonal stable cell pool models, non-injectable dosage forms, changes in clinical trials, guidelines and so forth, which applies to pharmaceutical research in phases of clinical application for novel coronavirus neutralizing antibody drugs.
3、The CDE issued Technical Guidelines for Clinical Study on Therapeutic Drugs for Age-related Macular Degeneration.
3、The CDE issued Technical Guidelines for Clinical Study on Therapeutic Drugs for Age-related Macular Degeneration.
Age-related macular degeneration (AMD) is a major cause of severe irreversible visual impairment. AMD has a huge unmet need for clinical therapy, and the disease has become a hot field of drug research and development. To further guide industry, researchers and regulators in the scientific development and evaluation of new drugs in this field, the CDE issued Technical Guidelines for Clinical Study on Therapeutic Drugs for Age-related Macular Degeneration on September 9th and it will take effect as of the promulgation date. The guidelines are mainly applicable to clinical study on new chemical medicines and biological products for the treatment of AMD, focus on discussing drug research and development and the principle of experiment design for advanced AMD with damage to visual function (nAMD - nAMD and/or geographic atrophy) and also discuss the research and development ideas and clinical trial designs of therapeutic drugs for AMD at Middle Stage, and visual impairment caused by choroidal neovascularization due to other etiology can also refer to some recommendations in the guidelines.
4、The CDE issued Technical Guidelines for Pharmaceutical Research and Modification of Biological Products During the Period of Clinical Trials (Online Draft for Comments).
In order to standardize the pharmaceutical research and modifications of biological products during the period of clinical trials, meet the basic requirements of phased samples for clinical trial, and protect the health of clinical subjects, the CDE issued Technical Guidelines for Pharmaceutical Research and Modification of Biological Products During the Period of Clinical Trials (Online Draft for Comments). The guidelines are applicable to pharmaceutical research and modifications of common biological products during clinical trials of different types and registered classes and their general requirements are also available for reference for advanced therapeutic biological products such as gene therapy and cell therapy, etc. The main content of the guiding principles consists of eight parts. The first and second parts mainly define the objectives and scope of application of the guiding principles, the subject's responsibility during the clinical period, the basic consideration and the comparability study and risk assessment of pharmaceutical changes. The third part mainly defines the basic requirements of biological products different types and classes of at different stages during the clinical period. The fourth part mainly explains the pharmacy change management during clinical period and gives examples of changes affecting safety. The fifth part emphasizes that the guidelines cannot cover all changes during the clinical period and encourages communication. From the sixth part to the eighth part, key references, key nouns, concepts and abbreviations appearing in the paper used in drafting the guidelines are enumerated and explained.
