CFDA strict drug review policy next year to market new drugs or significantly reduced


Release time:

2015-12-17


Due to the official release of the most stringent drug data verification requirements, the rejection of some drug registration applications, and the approaching deadline for the new version of GMP (Good Manufacturing Practice for Drugs) certification, not only will the production licenses of some pharmaceutical companies be canceled next year, even those that meet the new version of GMP requirements, the speed of new drugs to market will also be affected under the strict new drug review policy.
The State Food and Drug Administration issued the "Announcement on Carrying out Self-examination and Verification of Drug Clinical Trial Data" in July this year, and announced 1622 acceptance numbers (that is, 1622 drugs) that require self-examination. Data show that these acceptance numbers involve more than 800 companies, 103 of which are listed companies. This self-inspection announcement is also known as "the most stringent data verification requirements in history".
The Announcement requires that if companies that need to conduct self-examination fail to withdraw their registration applications for drugs with untrue and incomplete clinical trial data before August 25, they will face new drug registration within three years after the problems are found. Severe punishment for not accepting declarations. For listed pharmaceutical companies, the "three-year ban" means that they cannot declare new drugs, which will cause a huge blow to their performance and future development.
With the withdrawal of a new batch of 82 enterprises and 131 drug registration applications on December 14, 674 out of 1622 clinical self-examination acceptance numbers have been withdrawn or rejected, accounting for 47%. Among them, a large proportion of those who voluntarily withdraw account for a large proportion, which means that pharmaceutical companies have spent money on applications and time on research, but now they have to "kill" their unborn children.
Qilu Securities Research Report believes that the implementation of a series of new policies in the country will definitely reshuffle the industry. With the introduction of self-examination and a series of policies to encourage innovation, many enterprises will suffer in the short term, but at the same time, some high-quality pharmaceutical enterprises will benefit from this process.