The Party Central Committee of CPC and the State Council attach great importance to the regulation of drug safety. Therefore, in recent years, they have imposed a series of measures, striving to improve and strengthen authoritative organizations for food and drug safety supervision, establish the most rigorous regulatory system of the whole process, intensify the reform of drug evaluation and approval system, improve drug quality and safety and accelerate the sustainable and healthy development of medical industry, thus laying a solid foundation for ensuring and promoting public health. In the long run, these reforms aim to make drug regulation comply with related laws and make drug research, development and production more scientific. The food and drug administrations must implement the decisions and arrangements of the central government, continuously improve scientific regulation and spare no effort to ensure drug safety and efficacy.

To ensure drug safety and efficacy is the core content of scientific drug regulation.

As a special commodity for disease treatment and prevention, drugs must be safe and effective. Either manufacturers or regulators should always remember the goal of maintaining its safety and efficacy.

Strict adherance to the standards is the basic requirement of scientific drug regulation.

Because of its particularity, the drug has to be subject to the most rigorous commodity regulation by national governments. Accordingly, there are strict standards in research and development, production, circulation and use of drugs. For drug clinical trials, every single item of data must be recorded faithfully and timely to ensure its integrity and traceability.

Consistency evaluation of generic drugs is an inevitable choice of scientific drug regulation.

New drugs must be “NEW” and generic drugs must be “CONSISTENT”, which requires an indistinct substitution between generic drugs and original ground drugs. It is prohibited to release generic drugs that fail to meet the quality and efficacy requirement of original ground drugs.

The reform of drug evaluation and approval system is to realize more scientific drug regulation.

According to the requirements of the Party Central Committee and the State Council, we have taken a host of reform measures aiming at drug regulation, including simplified approval procedure for new drug clinical trials, records management of generic dugs clinical trials, data self-inspection of drug clinical trials and accelerated approval of urgently needed drugs.

Strengthening service awareness is an important manifestation of scientific drug regulation.

For regulatory authorities, enterprises are not only the supervision target but also the service target.