Finally, I'll be discussing the approval process for new drugs and how their safety is monitored

after they enter the market.

First, the approval decision is made by the national regulatory authority, which in Vietnam is the
Drug Administration of Vietnam. The manufacturer must provide data from preclinical and
clinical trials demonstrating that the drug meets criteria for efficacy and safety, and that the
dosage forms comply with quality standards.

Then the manufacturer submits a registration dossier containing:

1 The drug discovery and development process

2 Scientific evidence of efficacy and safety from preclinical and clinical studies
3 Information on the dosage form
4 Manufacturing processes
5 Proposed product labeling

An authority committee from the regulatory agency then reviews the dossier and decides whether
to grant marketing approval.

Once approved, the new drug can be sold under a trade name. At this stage, in addition to the
required Phase IV clinical studies, pharmacovigilance activities are crucial to identify and
manage( me nịt) risks from real-world use:

1 Suspected( sựt pếch tịt) adverse reactions must be reported to the national regulator
2 If the new drug has a similar safety profile and efficacy to existing treatments, the cost-
benefit ratio needs to be evaluated) I va liu ệt

Robust pharmacovigilance allows timely detection of rare or long-term adverse effects. This
ensures drugs remain safe for patients throughout their lifecycle after approval.

Manufacturers have a legal obligation to continually monitor and periodically reassess the risk-
benefit profile based on the latest data. In some cases, regulatory actions like label changes or
drug withdrawals may be necessary to protect public health.

In summary, while the approval pro cess aims to ensure new drugs are safe and effective before
reaching the market, proactive safety monitoring remains essential due to the limitations of pre-
approval trials. A collaborative effort between manufacturers, regulators, and healthcare
providers is key to fully characterizing the real-world effects of new drugs.

Thank you for your attention. I'm happy to take any comment and questions.