China relaxed regulations on imports of unapproved drugs via the revised drug administration law, which takes effect Dec. 1.
Lawmakers in the country voted to adopt the amended drug administration law on Aug. 26, according to the National People's Congress. One of the changes involves regulations on unapproved and substandard drugs.
Although overall regulations were tightened, lawmakers gave some leeway to drugs that have been approved overseas but have not yet gained regulatory approval in China. With the revision, importing a small amount of these drugs could be subject to a lesser charge than before, or could even be exempt from penalty.
This type of import has attracted the attention of lawmakers and the public in recent years as more Chinese patients attempt to access advanced treatments or cheaper generics from overseas which have not been approved in the country.
However, developing and selling fake drugs could bring fines of up to 30x the goods' value, or at least 1.5 million yuan, compared to the previous punishment of 2x to 5x the goods' value. Manufacturers and sellers of substandard drugs will also face a higher fine, equivalent to 10x to 20x the goods' value, compared to 1x to 3x before.
On top of fines, makers of fake drugs will also have their license revoked and will not be allowed to apply for a new license within 10 years.
Industry players are also watching regulations on online drug sales — it is uncertain whether China will allow the sale of prescription drugs via online platforms such as Alibaba Group Holding Ltd.
The second draft of the drug administration law released in 2018 had been geared toward a complete ban on online sales of prescription drugs. However, some lawmakers and experts, hoping to leave some rooms for selective prescription drugs, said a complete ban may not be appropriate.
Yuan Jie, a director of the Legislative Affairs Commission for the Standing Committee of the National People's Congress, said the amended drug administration law gives basic guidelines on online drug sales, but will let regulators come up with more detailed rules.
The drug administration law only states that online sellers are not allowed to distribute vaccines, plasma and other regulated medical products.
The revised law also encourages development of drugs for children. There are fewer studies in that field and demand is smaller compared to therapies for adults, said Liu Pei, a senior official with the National Medical Products Administration.
Liu said as a next step, regulators will come up with supportive policy to encourage development and innovation of medicines for children.
As of Aug. 26, US$1 was equivalent to 7.15 Chinese yuan.
