The state drug administration bureau promulgated the technical guiding principles for the revision of the processing specifications of the provincial traditional Chinese medicine

Enhance the quality controllability of Chinese herbal medicine

Time: 2018-04-23 source: Chinese traditional Chinese medicine report 1 edition author: chestnut sign

Report from our correspondent (reporter chestnut) in order to strengthen the management of the Chinese medicine yinpian, standardize the provincial Chinese medicine yinpian process for revision of the work, enhance the quality of Chinese medicine yinpian controllability, the state drug administration (fda) has issued the provincial Chinese medicine yinpian process for revision of the technical guiding principles, points out that the local pharmaceutical supervisory and administrative departments should be organized set up provincial yinpian processing standard revision work committee, responsible for the design and technical review.

"Guiding principles", stressed that the provincial yinpian processing should insist on the guidance of TCM theory, adhere to the revision of the norm in accordance with the standard revision, insist on the inheritance and protection of local characteristics, study the scientific and rigour, adhere to scientific and technological innovation and development.

The guidelines set out six basic requirements. One is revised provincial yinpian processing specification, deal with slices of medicinal plant, animal, mineral) varieties, character, origin, resources situation, the origin of processing methods, processing history, processing technology and its research progress, and quality control, clinical application and so on to conduct a comprehensive investigation and research; In addition to the requirements of the normal slices, the effect of the processing technology on the safety of the tablets should be investigated.

Second, the provincial yinpian processing specification should be in strict accordance with the relevant provisions of the pharmaceutical administration law and its implementing regulations, it contains only with local feature and history of clinic conventional varieties; It is not allowed to collect the scientific research products that are not in the scientific research stage without the recognized safety and effectiveness data, as well as the products controlled by tablets and granules, etc.; It should not be accepted as a specification for the consumption of the powder, except for the actual history of clinical practice.

Third, the content of the processing standard of the provincial drinking chip should be made according to the relevant requirements of the province and the quality control. The layout and body parts can be generally referred to the standard items and formats of the drinks in the current Chinese pharmacopoeia.

Fourth, the writing specification for the processing standard of provincial drinking chip can be carried out in reference to the current version of the technical specification of national drug standards. The terms, symbols, units of measurement, general codes, inspection methods and related requirements shall be carried out in accordance with the provisions of the Chinese pharmacopoeia.

5. All sample information, original records, pictures and other documents, samples and samples should be kept for archival purposes.

Six is released to the country "prohibited export restrictions on technology export management method" and the catalog of varieties of national science and technology secret contains yinpian processing technology or key varieties, shall comply with the relevant state confidentiality system, and the key processing technology and technological parameters in the release of the specification shall be reserved.

"Guiding principles", according to local pharmaceutical supervisory and administrative departments should be organized yinpian processing production, within their respective administrative areas, clinical application, analysis and inspection, drug supervision, and relevant experts, set up provincial yinpian processing standard revision work committee, responsible for provincial yinpian process for the project design and technical audit work. In general, the revision of the processing specifications of provincial slices should be carried out in an orderly manner according to the selection of varieties, collection of samples, research and development, technical review, consultation and release.

The guiding principles also put forward the requirements for the research work and technical examination of the processing standard of the provincial drinking chip. This guideline can be referred to in the revision of the processing standard of ethnic minority medicines.