Pharmaceutical News
Drug guardian policy in place to usher in a new era of Al-powered drug lifecycle management
2019/04/19

The Taiwan Food and Drug Administration introduced a new “Good Drugs in the Artificial Intelligence Era” pharmaceutical monitoring policy that leverages new technologies to protect public health and safety.

To improve pharmaceutical lifecycle management, the policy is listed as follows

 

1.     (Good Registration Management, GRM): Improve efficiency of evaluation and regulatory approval processes to match global standards.

2.     (Good Laboratory Practice, GLP): Improve toxicology studies in clinical trials and to ensure the integrity of data collected. 

3.     (Good Clinical Practice, GCP): Improve the quality of clinical trials and safeguard the wellbeing of clinical trial participants.

4.     (Good Manufacturing Practice, GMP): Bolster management of ingredient sources and ensure manufacturing quality control.

5.     (Good Distribution Practice, GDP): Improve sales and distribution and tracking and traceability.

6.     (Good Pharmacovigilance Practice, GPvP): Improve drug safety monitoring after new products are launched as well as ensuring timely communication regarding potential risks.

7.     (Accessibility): Accelerate new drug approvals and prevent drug shortages.

8.     (Intelligence): Deploy electronic smart management solutions to set a new standard for the pharmaceutical industry.

 

【2019-4-17 TFDA】