home > ict > spring 2016 > indonesia
International Clinical Trials


As the pharma hub of the Association of Southeast Asian Nations (ASEAN) region, Indonesia has recently seen great progression and rapid advancement of technologies and service offerings. It has taken centre stage in terms of clinical trials, with 49 currently underway (1).

The Asia-Pacific region is known for having a comparatively shorter timeframe for clinical trial duration, as well as being relatively less expensive – with a population of almost 256 million people (2) and a high incidence of diseases, ranging from tropical diseases to diabetes, asthma and malaria (3). These factors, combined with Indonesia’s current surge in research activity, have opened the door for an increasing amount of clinical trials to take place in the country. Although clinical trial expertise have been brought from more mature research countries such as India, China and Taiwan in the past, local expertise is now essential for success.

Trial management has always been reliant on local knowledge in order to successfully carry out a clinical trial – it is vital to the entire process. Factors such as cultural sensitivity, patient adherence and communication are heavily dependent on local insight, which help provide a bigger pool of patients and usable data in a shorter time. The question of how to contact patients, as well as the best way of managing adherence in terms of communication methods, relies on the local expertise of researchers. For example, information on how the internet has penetrated the population, and what the patient’s preferences in communicating are, prove to be of great importance. Their habits and uses of technology are significantly beneficial in how to best interact with patients, and therefore how to best manage the trial.

In fact, Indonesia is one of the most ethnically diverse countries in the world, and while Malay is the main language, there are still over 700 indigenous languages spoken in the territory – making speaking skills all the more important. Throughout the trial, doctors need to be able to communicate with the patient so they can see how effective the drug is, what side effects might be occurring, and any other factor relating to their care.

Moreover, Indonesia also presents major distribution challenges for both healthcare providers and clinical trials. The country comprises 17,000 volcanic islands, and local knowledge will be central in identifying the best and most viable transport routes, distribution centres and companies.

Finally, the gentrification of the country provides ongoing challenges for clinical studies in the region, as it is a rapidly evolving healthcare structure. Thus, local expertise is vital in understanding the current practices in the country. The ASEAN region also holds the world’s largest population of people that have never undergone treatment or a clinical trial, which means that they need a more prescriptive approach in terms of educating and walking them through trials.

Regulatory Approval

The ongoing harmonisation across the ASEAN region is expected to accelerate growth and foreign investment; without local knowledge, however, companies looking to attain regulatory approval will find the process challenging. For example, in Indonesia – as in other Southeast Asian countries – the Ethics Committee (EC) approval letter needs to be enclosed within the regulatory submission package. Therefore, submission can only be made after EC approval, and this in itself can take between four and seven months. In a process where each day of delay means a reduction on their budget, having the upper hand in the bureaucratic and regulatory processes is critical.


1. CenterWatch, Indonesia Clinical Trials, 2016. Visit: Indonesia
2. The World Factbook, East and South East Asia: Indonesia, CIA, 2016. Visit: id.html
3. Ministry of Health, Republic of Indonesia. Indonesia Health Profile 2013. Visit: indonesia/Indonesia%20Health%20Profile%202013%20 -%20v2%20untuk%20web.pdf

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:

There are no comments in regards to this article.

Rutger Oudejans has been Brand Director Pharma at UBM EMEA since April 2014. He is a creative, strategic and highly experienced business leader, with handson pharmaceutical industry knowledge and a long track record in previous roles across Asia, focusing on functional excipients as well as formerly representing UBM's pharma division for several years. A core part of his responsibilities is to drive forward the CPhI Worldwide and CPhI India brands and co-located events.
Rutger Oudejans
Print this page
Send to a friend
Privacy statement
News and Press Releases

CPhI MEA expert:growing domestic manufacturing is creating new opportunities for international Pharma in the Middle East

Abu Dhabi, 5th August 2019: CPhI Middle East expert Emad Shabbir, Director at EMAD Trade House, states favorable conditions and legislative regulations in Saudi Arabia are resulting in a boom of manufacturers and CMOs partnerships with international pharma companies. With the strategic cooperation between regional generic companies and multinational pharma companies, driving increased local production.
More info >>

White Papers

Delivering Fit For Purpose Biomanufacturing CHO Cell Lines

Fujifilm Diosynth Biotechnologies

The challenge during mammalian cell line development is to identify and isolate stable, high expressing cell lines producing product with the appropriate critical product quality attributes rapidly, reproducibly and with relative ease. Obtaining a host cell line that inherently exhibits desirable biomanufacturing attributes can therefore have a significantly positive effect on the identification of recombinant cell lines with desired traits during cell line development screens. In this study, we demonstrate that it is possible to exploit intrinsic heterogeneity within host cell populations and identify host cell lines which are more “fit for purpose”.
More info >>

Industry Events

Nordic Life Science Days 10/12 September 2019

10-12 September 2019, Malmo Sweden

Nordic Life Science Days is the largest Nordic partnering conference for the global Life Science industry. Bringing together the best talents in Life Science, offering amazing networking and partnering opportunities, providing inputs and content on the most recent trends. Nordic Life Science Days attracts leading decision makers from the Life Science sector, not only from biotech, pharma and medtech but also from finances, research, policy and regulatory authorities.
More info >>



©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement