In Indonesia, Southeast Asia's largest consumer market, and Vietnam, a country which has seen a significant rise in rates of health insurance coverage, the pharmaceutical industry continues to grow apace. However, both countries are highly dependent on imported pharmaceutical products. While this provides valuable opportunities for drug importers, increasing regulatory requirements have made this process challenging.

In this webinar, Irene Djalim, Manager of Regulatory Affairs at Tilleke & Gibbins Indonesia, and Hien Thi Thu Vu, Head of Regulatory Affairs at Tilleke & Gibbins Vietnam, will provide an overview of the regulatory framework for the importation of pharmaceutical products in these two countries, including the requirements for obtaining marketing authorization.

Other Session

Marketing Authorization and Regulatory Requirements for Exporting Drugs to Thailand

Understanding Regulatory Requirements for Exporting Drugs to Cambodia, Laos, and Myanmar

INDONESIA

1. Indonesia Pharmaceutical Market Outlook

2. Regulatory Framework and Competent Authority

• 2.1 Legislation update

• 2.2 Competent authorities

3. Drug Product Requirements

• 3.1 Definitions and classifications

• 3.2 Good Manufacturing Practices (GMPs) and overseas manufacturing sites

• 3.3 Obtaining a marketing authorization license

VIETNAM

1. Vietnam Pharmaceutical Market Outlook

2. Regulatory Framework and Competent Authority

• 2.1 Legislation update

• 2.2 Competent authorities

3. Drug Product Requirements

• 3.1 Definitions and classifications

• 3.2 Good Manufacturing Practices (GMPs) and overseas manufacturing sites

• 3.3 Obtaining a marketing authorization license 

4. Regulatory Reforms

• 4.1 Draft Law Amending the Law on Pharmacy