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Six years ago, on July 22, the State Food and Drug Administration issued the "Announcement on Carrying out Self-examination and Verification of Drug Clinical Trial Data" (2015 No.
Six years are fleeting, with joy, pain, confusion, and determination.
Accelerated review and approval of generic drugs
The review and approval system reform opinions put forward 5 goals and 12 measures.Source: PharmaGO
At the same time, it can be seen that the speed of CDE's review and approval has been greatly improved
Source: PharmaGo
The consistency evaluation of stock generic drugs is gradually withdrawn
At the end of 2018 , the "Announcement on Matters Concerning the Quality and Efficacy Consistency Evaluation of Generic Drugs" issued by the National Medical Products Administration pointed out that the varieties that passed the quality and efficacy consistency evaluation of generic drugs were given priority to be included in the catalog, and the varieties that did not pass the consistency evaluation Will be gradually transferred out of the catalog, and fully consider the importance of essential medicines to ensure clinical needs.
This action shows that the National Medical Products Administration no longer uniformly requires that the consistency evaluation of essential drugs be completed before the end of 2018
Source: PharmaGo
The huge market sales have become a driving force for companies to accelerate the completion of the consistency evaluation of generic drugs
Source: PharmaGo
Correspondingly, the number of products approved to pass the consistency evaluation of generic drugs is also increasing
Source: PharmaGo
Future Trends of Generic Drugs: Seize the Opportunity
The above is an overview of the development and changes of China's generic drugs in the past 6 years based on the historical data of drug registration, as well as a deduction of the trend of future generic drug registration applicationsSource: PharmaGo
On the other hand, contrary to excessive repeated declarations, the exclusive varieties of generic drugs in China still account for an excessively high proportion.
Source: PharmaGo
Whether it is excessive repetition or a dominant one, one of the main reasons for this polarization of declarations is information asymmetry
In short, the development of generic drugs must be comprehensively considered market expectations, corporate strategic planning, production lines, business advantages, external competitive environment and other factors
.
In the current competitive environment of the generic drug market, especially after the state's centralized procurement has become regular, the market competition situation has undergone profound changes
.
The sooner you learn about the trends of competing products, the more likely it is to avoid getting together, reduce R&D waste, and help invest resources in R&D activities with a higher rate of return
.
