In recent ten years (especially in the years before 20 15), the supervision of clinical application of stem cells in China has been in a multidisciplinary situation. SFDA and the Health Planning Commission issued relevant regulations respectively, and the industry's response unexpectedly chose a simple and easy way.
As early as1May 26, 1999, SFDA promulgated the Measures for the Examination and Approval of New Biological Products, and in the Measures for the Administration of Drug Registration (Trial) (Order No.35) promulgated on October 30, 2002, somatic cells were officially listed as three new biological products. This provision has been followed in all previous revisions of the Measures for the Administration of Drug Registration. Therefore, SFDA's attitude towards the listing of stem cells has not changed, that is, it is declared according to three types of new drugs of biological products.
Official website search results of SFDA Drug Evaluation Center show that up to now * * * has accepted 1 1 stem cell drug declaration (excluding cancellation after declaration), mainly mesenchymal stem cell injection from umbilical cord and bone marrow, and its indications include liver fibrosis, myocardial infarction and so on. The earliest declaration can be traced back to "Bone Marrow Primitive Mesenchymal Cells" declared by the Institute of Basic Medicine of China Academy of Medical Sciences on June, 2004. In addition, according to the retrieval results of drug clinical trial registration and information publicity platform of SFDA Drug Approval Center, bone marrow mesenchymal cells * * * have carried out three drug clinical trials (CTR20 132003, CTR20 132698, CTR20 13202), and the indications include graft-versus-host disease. However, the above-mentioned 1 1 stem cell drug application has not entered the approval process, which makes people wonder what will happen in the next decade.
As for the Health Planning Commission, CIK immune cell therapy was included in the 200 1 version of the national medical service price project specification (for trial implementation) promulgated on June 24, 2000, which provided a legal basis for charging. Autoimmune cells and stem cells were listed in the Catalogue of Clinical Application of the First Class Medical Technology released on June 1 1 2009, and stem cells actually obtained legal listing status. Related enterprises naturally have no motivation to invest in the research and development of stem cell drugs, which has laid a hidden danger for the chaos of stem cell clinical application, so that on February 26, 201kloc-0/65438, the Notice on Self-examination and Self-correction of Stem Cell Clinical Research and Application was issued, and the stem cell clinical research was urgently stopped. 2065438+On June 29th, 2005, the Health Planning Commission issued the Notice on Canceling the Examination and Approval of Clinical Application of Class III Medical Technology, and devolved the main responsibility to medical institutions. Without the endorsement of government departments and the "Wei Zexi" incident exposed on 20 16, the era of charging for cell therapy is over. Everything is back to the starting point.
After learning the previous painful lessons, SFDA and the Health Planning Commission jointly promulgated the Administrative Measures for Stem Cell Clinical Trial Research (Trial), the Administrative Measures for Stem Cell Clinical Trial Base (Trial) and the Guiding Principles for Quality Control and Preclinical Research of Stem Cell Preparations (Trial) on March 7, 2005.
In addition, the Health Planning Commission issued the Notice on the Filing Work of Stem Cell Clinical Research Institutions on February 20 1 May, which opened the door to drug declaration and allowed some institutions with relevant qualifications to carry out stem cell clinical research without charge. The research results can be used as information for drug declaration, simplifying the procedures for carrying out stem cell clinical research. The first batch of 42 hospitals were approved, including 30 hospitals approved by the two committees, 2 hospitals approved by the Health Bureau of the Military Commission, and 6 clinical research projects were put on record.
Joining talents from many fields is the solution.
In the movie world without thieves, the role played by Ge You has a classic line: "What is the most precious in 2 1 century? Talent! " . So is the research and development of stem cell drugs. At present, the leading force in the field of stem cell research is scientific research units. Among the 68 major stem cell projects approved in 20 16 and 20 17, none was led by the company, which highlighted the shortcomings of industrialization.
Compared with basic and clinical research, stem cell drug development is a huge systematic project, involving cell culture, identification, preparation, quality control, preclinical research (pharmacology, toxicology, pharmacokinetics, etc. ), clinical trials and other links. In addition to scientists, there is a shortage of talents with engineer and pharmaceutical background. The participation of talents in many fields will have a synergistic effect and promote the research and development process of stem cell drugs.
We guess that the first stem cell drug in China is expected to be approved in five years.