China revises law to ensure drug safety

China's top legislature on Monday voted to adopt the revision to the drug administration law as part of the country's efforts to ensure drug safety and meet people's health demands.

Lawmakers approved the revision at the closing meeting of a five-day bimonthly session of the National People's Congress (NPC) Standing Committee.

Aimed at addressing prominent problems of the pharmaceutical industry, such as counterfeit and substandard drugs and high drug prices, the revised law stipulates the strictest standards and toughest measures in supervision over the whole process of the industry chain.

The drug administration law was first promulgated in 1984. Monday's revision is the first overhaul since a 2001 revision.

The newly revised law will go into effect on Dec. 1, 2019.

All-round supervision

According to the law, supervision of drugs will be further tightened and expanded to cover the whole process, including the research and development, production, sale, use and management of drugs.

An entire chapter is dedicated to a new "medicine marketing authorization holders (MAHs)" system.

Individuals and entities who have become the medicine MAHs shall be responsible for the full "life cycle" of drugs, including clinical and non-clinical trials, manufacturing, selling, and the analysis, report, and response of adverse reactions.

A "full traceability" mechanism and a drug recall system will also be introduced.

The law covers online drug sales, a new area in need of better supervision.
The online sale of drugs shall abide by relevant stipulations on the sale of drugs proposed in the law, it says, adding that vaccines, blood products, anaesthetic and radioactive drugs and other drugs under special administration shall not be sold online.

Tough measures

The law has stipulated the toughest punishment to protect the rights and interests of the people, said Yuan Jie with the Legislative Affairs Commission of the NPC Standing Committee, at a press conference held after the legislative session.

The revision has increased both the lower and upper limits of the penalties in the law. For instance, those who produce counterfeit drugs will be fined 15 to 30 times their earnings, as opposed to two to five times before the revision.

Several occasions are also stipulated in the law where heavier punishment is applicable, including producing and selling counterfeit or substandard drugs for pregnant women and children.

Drug watchdogs will be hit with heavy punishment if they are found guilty of dereliction of duty when handling counterfeit or substandard drug cases.

Innovation encouraged

In addition to tightening supervision to ensure drug safety, the newly revised law also encourages innovation in the research and development of new drugs.

"The law underscored China's commitment to pharmaceutical research and development in the general rules section, and added or improved over 10 clauses to encourage innovation," said Liu Pei, a senior official with the National Medical Products Administration.

Innovation will be encouraged in developing drugs that have confirmed or special curative effects or a new mechanism of action, and drugs that can cure life-threatening or rare diseases, the law stipulates.

The development of new types of pediatric medications will also be supported, according to the law.

Drugs of clinical urgency and new drugs or pediatric drugs that can prevent and cure serious infectious or rare diseases will be first greenlighted for the market.

Editor: John Li