Pro inspectors to guard drug safety

China's National Medical Products Administration will set up inspection teams to strengthen the supervision and regulation on the safety of drugs, as well as medical equipment, cosmetics and vaccines.

The inspection teams, which will include pharmaceutical professionals, will check whether sites and activities related to the research and manufacturing of drugs are up to standards while evaluating their risks.

The General Office of the State Council said recently that a system of inspection teams at central and provincial levels will be established by the end of next year.

The system will divide team members into four levels, from junior inspector to expert inspector, based on their professional skills and background, the office said in a statement.

In the three to five years from 2020, the system will be able to basically support the country's drug regulation demands, with full-time inspectors as the primary forces and trained part-time inspectors as supplementary forces.

The inspections conducted at the central level will cover clinical and nonclinical research procedures regarding drugs, medical equipment and cosmetics for special use. The provincial level inspections will focus on the production of drugs, medical equipment and cosmetics, as well as their sale at the wholesale and retail levels, including online sales.

Inspections of the usage of drugs, medical equipment and cosmetics will be handled by town-and county-level departments, according to the statement.

The inspections will also be under public supervision. Those found to have acted irresponsibly or illegally will be punished.

The statement emphasized that the efforts will further tighten safety inspections on drugs with high public health risks, especially vaccines.

The central team will conduct unscheduled inspections of vaccine research and production. Provincial drug regulatory authorities should be responsible for regular safety checks on vaccine production, usage and adverse effects.

More efforts should be put into the establishment of inspection teams for vaccines and other drugs that are apt to pose risks, and inspections in this field should be further intensified, according to the statement.

China's top legislature passed a law on vaccine administration in June, requiring a whole process supervision system and strengthening penalties on related violations. The law will go into effect on Dec 1.

In 2016, officials from state drug regulatory authorities had revealed that professional inspection teams on drug and food safety will be formed, expecting to train 300 full-time inspectors at the state level by 2020.

During this year’s "two sessions" meetings in March, Jiao Hong, head of the National Medical Products Administration, said the inspection teams are built to better detect problems and possible loopholes in the related industries and further guarantee public health.