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.

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

* The final outline may be subject to subtle revision.

Schedule

Irene Djalim

Irene Djalim is the manager of the regulatory affairs department in Tilleke & Gibbins’ Jakarta office. With a strong technical background and detailed knowledge of Indonesian intellectual property law, Irene handles the prosecution of patent applications in mechanical, chemical, and pharmaceutical fields, in which she helps inventors protect their innovations. She prepares and files applications for patents, petty patents, and industrial design patents, prosecutes the patents until they are granted, and maintains the patents after they are granted. Irene also regularly performs patent searches as well as freedom-to-operate analyses and infringement assessments. Irene has provided regulatory advice on product registration of traditional medicine in Indonesia with the Indonesian FDA (BPOM). She graduated with a degree in chemical engineering from the Georgia Institute of Technology and obtained a Magister Akuntansi from Institut Bisnis dan Informatika Indonesia. Prior to specializing in patent work, she had experience working in a United States government agency and an automotive manufacturing facility in Indonesia. Irene is a registered IP consultant in Indonesia.