Drug administration to be established in 2022

A public drug administration entity will be established in 2022 alongside the promulgation of the bill governing the regulation of traditional Chinese medicine, which is currently under discussion at a parliamentary committee.
The committee held a discussion on the bill Tuesday. Bringing the future law into effect will require a public drug administrative body. Government representatives told the committee that it aims for the law to take effect in 2022.
With regard to patents issued for medications, lawmaker Ho Ion Sang, president of the committee, revealed that only self-researched data will be protected. The bill proposes that new medicines will have six years of patent protection covering data from pharmacology, toxicology research and clinical trials. Upgraded medications will have four years of patent protection covering self-researched data generated from pharmacology, toxicology research and clinical trials.
Ho disclosed that the Health Bureau has consulted experts and scholars from mainland China to update certain definitions within the bill. For example, the term “Chinese medical extracts” refers to products used as mediums that have been manufactured from plants, animals or minerals, or their by-products. “Natural medicines,” meanwhile, refers to medicinal products that are derived from nature.
Ho further disclosed that the bill proposes more lenient punitive measures for first-time violations. If the violator is a first-time offender who has not committed a breach in the previous two years and did not create serious public risks with the violation, the “highest leader of the supervisory entity” has the power to reprimand the violator.
Ho did not say whether the Health Bureau or the proposed drug administration body will be the supervisory entity. AL