Problems and Suggestions in the Registration and Approval of Chemical Preparations in Medical Institutions of Guangdong Province
- VernacularTitle:广东省医疗机构化学药制剂注册申报存在的问题及建议
- Author:
Jiarun CHEN
1
;
Xiaoli SHEN
2
;
Xiaoying WANG
1
;
Yingzhu JIANG
1
Author Information
1. Center for Evaluation and Certification，Guangdong Drug Administration，Guangzhou 510080，China
2. Guangdong Food and Drug Vocational College，Guangzhou 510520，China
- Publication Type:Journal Article
- Keywords:
Chemical preparations in medical institutions;
Registration;
Problems;
Suggestions
- From:
China Pharmacy
2019;30(22):3030-3034
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE： To provide reference for ensuring clinical drug safety and promoting the development of characteristic chemical preparations in medical institutions. METHODS： From three aspects such as registration declaration of new preparations， supplementary application declaration and re-registration declaration， the problems found during the technical review of registration of chemical preparation in medical institutions of Guangdong province have been summed up， the causes of above problems also have been analyzed， and the relevant suggestions have been given at the same time. RESULTS & CONCLUSIONS： There were deficiencies in the registration declaration of new preparations， such as insufficient basis for the title， the lack of key process parameters in the study of preparation process and the failure of stability test conditions to meet the requirements of the Pharmacopoeia， etc. There were deficiencies in the supplementary application declaration， such as the unreasonable formulation of drug， the interaction between the drugs packing material and the drug， and unreasonable setting of storage conditions. There were deficiencies in the re-registration declaration， such as the supply of existing drugs on the market， the lack of production conditions for the formulation unit， the inability to purchase the original excipient materials， and the incomplete attention items. The main reasons were that the lack of technical guidelines for the research of chemical preparations， imperfection of the Standards for the Quality Management of Pharmaceutical Preparation in Medical Institutions and authorized preparation of chemical agents not allowed in Measures for the Registration and Administration of Pharmaceutical Preparation in Medical Institutions， and some kinds of chemical preparations could not adapt to the development of the new situation. The solutions are to improve the regulations of medicinal preparation in medical institutions and develop chemical preparations selectively based on safety and efficiency. In the future， the problems can be solved by formulating the technical guidelines for the research of chemical preparations in medical institutions， refining the rules for the retention of samples in finished products， increasing the requirements for continuous stability inspections， allowing authorized chemical preparations to be commissioned and prepared， phasing out the chemical preparations that do not adapt to the new situation， and developing valuable chemical preparations， to provide safe and effective chemical preparations for clinical use.
