Major Reforms of the Review for Registration and Market Approval of Drugs

Reference: http://www.fda.gov.tw/eng/news.aspx?newssn=8817&key_year=2012&keyword=

—

The Department of Health of Executive Yuan promulgated the partial amendment of the “Criteria Governing the Review for Registration and Market Approval of Drugs” on May 8, 2012. The original criteria required that the application of the review for registration and market approval of new drugs should be submitted along with the Permit for Manufacturing and Sales from Country of Origin/Certificate of Pharmaceutical Product in addition to relevant administrative and technical data. This provision was set because there were no legal as well as scientific standards in compliance with the then international requirements in the domestic pharmaceutical industry in the past, and regarding the nature of the aforementioned provision, the aforementioned permit/certificate issued by the then ten most medically advanced countries was expected to prove that the quality, safety and effectiveness of the said new drug had been approved in those countries and serve as reference during the review for registration and market approval of the new drugs in Taiwan.

Nowadays, the review and administration for registration and market approval of new drugs have reached the level equal to that of medically advanced countries, and the Center for Drug Evaluation (CDE) has been established to offer professional reviews on the technical data provided by the application of the review for registration and market approval of new drugs. Therefore, the review on the new ingredients of the imported new drugs is conducted only on the scientific basis and non-scientific factors (the requirement for the Permit for Manufacturing and Sales from Country of Origin/Certificate of Pharmaceutical Product) are discarded. However, the Permit for Manufacturing and Sales from Country of Origin/Certificate of Pharmaceutical Product (CPP) is considered as an auxiliary document now. Besides, in accordance with the risk level of drugs, the corresponding risk management system and review requirements are established. Hence, the “Criteria Governing the Review for Registration and Market Approval of Drugs” are amended and the major amendment is listed as follows:

1. The provision stipulating that the application of the review for registration and market approval of the new ingredients of new drugs should be submitted with the CPPs issued by more than two countries can be relaxed on condition that the said application should provide information regarding the domestic clinical trials or the multinational and multicenter trials with the involvement of Taiwanese people.
2. A drug policy management system based on risk classification is established, and the aftermarket risk management of drugs is reinforced by actions such as requiring the pharmaceutical factory to submit a drug risk management plan.
With the aforementioned amendment, it is expected that the public can take advantage of the safe and effective new drugs developed abroad earlier and the public interests and health, therefore, are enhanced.