2017 is so extraordinary
For the research and development industry of drugs and medical devices, 2017 is destined to be an extraordinary year. For clinical researchers, this “extraordinary” year is mainly reflected in the following five aspects:
More in-depth self-examination
After the self-inspection verification announcement was issued on July 22, 2015, regardless of the sponsor, CRO or clinical research institution, the importance of clinical research quality has risen to unprecedented heights. By the end of 2016, with the launch of ICH E6 R2 in the United States, risk-based clinical research quality management has also received increasing attention. In 2017, the momentum of strengthening quality management is still in the ascendant, and self-inspection and verification work has been carried out in more depth.
Consistency evaluation has reached a climax
Following the “Opinions on Reforming the Review and Approval System of Drugs and Medical Devices” promulgated by the State Council on August 18, 2015, the CFDA issued the “Announcement on Several Policies on Drug Registration Review and Approval” on November 11, 2015. On March 5, 2016, the “Opinions of the General Office of the State Council on Carrying out the Quality and Efficacy Consistency Evaluation of Generic Drugs” was launched, pushing the consistency evaluation of generic drugs to a climax. At the beginning of 2017, CFDA promulgated a series of documents that provide specific guidance for consistency evaluation, such as the General Considerations for Clinical Effectiveness Trials of Generic Drug Quality and Efficacy Consistency Evaluation, so that the development of consistency evaluation work can be followed by law.
Medical device regulations are advancing by leaps and bounds
Compared with the research and development of new drugs, the laws, regulations and guiding principles related to the clinical research of medical devices were not mature before, which once caused difficulties in the research and development of medical devices. At the beginning of 2017, the “Medical Device Evaluation Communication Management Measures” was promulgated, which facilitated medical device sponsors to consult directly with the drug regulatory authority. In addition, in 2017, about 50 medical device registration technical review guidelines were announced, providing technical support for the registration of medical devices.
Cell therapy has guiding principles
In terms of cell therapy, after launching the first batch of stem cell clinical research institutions in 2016, the second batch of stem cell clinical research institutions was launched in November 2017. At the end of 2017, the “Technical Guidelines for Research and Evaluation of Cell Therapy Products” was promulgated to provide a theoretical basis for clinical research on cell therapy. The first clinical study of CAR-T cells in China has also been approved by CFDA. This also shows that the management of biotechnology such as cell therapy is gradually being transferred from the former Health and Family Planning Commission to CFDA. This is undoubtedly beneficial to the sponsor, because the Food and Drug Administration is more mature in terms of clinical research management.
New drug research is fully in line with international standards
The most important announcement in 2017 was the “Opinions on Deepening the Reform of the Review and Approval System and Encouraging Innovation in Drugs and Medical Devices” issued by the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council on October 8, 2017. Research and development are fully in line with international standards. Two days later, CFDA promulgated the “Decision on Adjusting Related Matters Regarding the Registration and Administration of Imported Drugs”, announcing that for those international multi-center drug clinical trials conducted in China, phase I clinical trials are allowed to be carried out simultaneously, and the drugs used for canceling clinical trials should have been registered overseas , Or have entered the requirements of phase II or phase III clinical trials, except for preventive biological products. It shows that CFDA is keeping up with the steps of the General Office of the CPC Central Committee and implementing the spirit of the Central Committee. In addition, China announced its accession to ICH, which is also a historic event in China’s new drug development field.
The future has come, whose opportunity and challenge?
The overall good situation of the clinical research industry is not necessarily beneficial to all CROs. Some small domestic CROs may encounter difficulties; the overcrowding of clinical research in large hospitals will not be immediately changed
2017 is a year of inheriting the past and the future, and we can foresee the rapid development of clinical research in China in the next few years.
For large international CRO companies, there will undoubtedly be major benefits. More and more clinical research, especially early clinical research will be introduced into China, more hospitals will join the ranks of clinical research, more doctors and patients will participate in clinical research. China’s pharmacological institutions will be more mature and will be more conducive to the research and development of new drugs.
However, the overall good situation in the clinical research industry is not necessarily beneficial to all CROs. For some small domestic CROs, they may encounter difficulties. Because the quality standards and professional capabilities of small domestic CROs may not necessarily be recognized by large international pharmaceutical companies. Although more international multi-center clinical research will flood into China, it may not necessarily bring business growth to small CROs. On the contrary, due to the expansion of large CRO companies, it will also increase the pressure on talents of small CRO companies. Therefore, for the CRO industry, there will be a few happy and sad. Small CRO companies should expand new businesses in a timely manner and carry out appropriate transformations.
Institutional liberalization is both an opportunity and a challenge. Some inexperienced researchers join the clinical research, which brings risks to the quality of clinical research. In addition, despite the liberalization of institutions, many sponsors or CROs will still give preference to investigators with more experience or cooperation. The overcrowding of clinical research in large hospitals will not be immediately changed. In this case, it is like a large hospital with many patients, but most patients are still willing to squeeze into a large hospital. Therefore, it has become very important to train newly joined research institutions and educate newly joined researchers, and a training market is also formed. In fact, doctors with medical qualifications should have the ability to do clinical research, but most clinicians do not understand and pay little attention to clinical research, and do not develop good operating habits. This is the problem that sponsors and CRO companies have been facing.
In short, 2017 is a year of hope for the new drug research and development industry, and we believe that the future will be better.