China's generic drug development has changed dramatically in the past 6 years

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.

According to the data of PharmaGo, CDE solved the problem of the backlog of applications at the end of 2017

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

Consistency evaluation gradually withdrew

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.

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 applications

From the perspective of variety competition, there have always been two extreme phenomena in the development of generic drugs in China.

Source: 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