This amendment was due to the increasing demand for narcotic drugs for pain management and the innovation of pharmaceutical technology. The TFDA pharmaceutical plant for controlled drugs must cooperate with other private pharmaceutical industries in order to reach the goal of steady supply of the schedule I and II controlled drugs to meet the domestic medical demand.

The major issues of the amendment are as below:

When necessary, MOHW can contract out making schedule I or II controlled drugs to a third party manufacturer. The amendment authorizes MOHW to set regulations to determine the qualifications and management of the contract manufacturing plant, and to revise the relevant penalties.

Secondly, The TFDA may use the schedule I and II drugs that have not yet been approved by the authorities for medical and scientific research.

Third, in practical terms, the TFDA pre-estimated demand of schedule I and II drugs have to be reported to the MOHW, instead of reporting to the Executive Yuan for approved.

Fourth, with the government reorganization, the authority names have been revised.

After the amendments, the government will have a clear authority by law to commission the private pharmaceutical industry to produce schedule I and II controlled drugs. The government can also regulate  management and security of all manufacturing facilities and products. It is effective and advantageous for controlled drug supply.