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In response to the pandemic, every country and region is placing greater importance on preparedness, including by building vaccine development and production capacity. Efforts to provide protection for Indonesia’s large population make vaccines an important product in the health system and national resilience. The availability of sustainable and public health-based vaccine development and manufacture needs to be supported by a good ecosystem. These efforts must be carried out through a policy and regulatory framework that is oriented towards aspects of safety, quality and efficacy for public health.
In line with these efforts, the Ministry of Health together with the Duke-NUS Center of Regulatory Excellence (CoRE) collaborated with the Health Sector Group of the Asian Development Bank (ADB) to hold a meeting with domestic vaccine industry stakeholders to discuss vaccine regulations in Indonesia. Since 2023, Duke-NUS CoRE has collaborated with ADB to implement the ADB Vaccine Regulation Project with the aim of strengthening systems and analyzing the regulatory landscape in the Asia Pacific region, especially in developing countries such as Indonesia regarding handling pandemics/public health emergencies and treatment for other infectious diseases which also encourage access to innovative products, attract investment in production, and improve public health surveillance systems. The main purpose of this collaboration is to enable access to safe, efficacious and quality products through a range of scientific and regulatory activities deployed across the entire product life cycle. Countries covered in this collaborative project include Bangladesh, Cambodia, Laos, Indonesia, Myanmar, Thailand and Vietnam.
As a first step, Duke-NUS CoRE-ADB conveyed the aspects that will be analyzed in this project, including perspectives on the role of regulations on the vaccine ecosystem, national governance, regulatory capacity building, regulation of the vaccine life cycle, regional and global perspectives, as well as a roadmap for regulatory system strengthening. Also present in the event the Executive Director of the Center of Regulatory Excellence Duke-NUS Medical School, Professor John CW Lim and the Director of the Human and Social Development Office Sector Group Asian Development Bank Dr. Patrick L. Osewe to address remarks in the meeting.
Minister of Health Budi G. Sadikin appreciated and welcomed the collaboration between Duke-NUS CoRE and ADB. Minister of Health Budi conveyed the importance of strengthening the regulatory system in the Asia Pacific region, and hoped that this collaboration could have a positive impact in building a vaccine development ecosystem in the Asia Pacific, especially in Indonesia.
“We realize that the regulatory system plays an important role in providing faster services to the public. Reviewing, licensing, controlling and supervising pharmaceuticals and vaccines is a major challenge for national governance, in this case the national regulatory authority which is currently under government supervision faced with an increasing number of new products, complex quality problems and new technical problems arising from the rapid development of the pharmaceutical industry and advances in science. There is a need to strengthen national policies and regulatory authorities that are recognized worldwide,” said Minister Budi.
Furthermore, Director General of Pharmaceuticals and Medical Devices L. Rizka Andalusia explained that the availability of sustainable vaccine production needs to be supported by a good ecosystem so that national vaccine independence and resilience can be achieved.
“The Economist states there are 5 (five) pillars that form the basis of a vaccine development ecosystem to achieve vaccine resilience, namely Research and Development; Manufacturing; Procurement, Pricing and Finance; Distribution, Logistic and Supply Chain Management, and User Acceptance and Uptake. All of this should be supported by robust and agile regulatory action”, said Director General Rizka.
In line with the intention to realize health resilience in the field of vaccines, the Ministry of Health launched the Vaccine Collaborating Center (VOLARE) initiative which aims to strengthen national and global collaboration to achieve vaccine independence and resilience and increase access to quality health products for the community. This initiative combines the potential and existing innovation ecosystem, involving the participation of various stakeholders to work more synergistically.
The VOLARE initiative launched by the Indonesian Minister of Health aims to master the latest vaccine technology, development capacity of national program vaccine and vaccine for pandemic response with 4 scopes, including:
“I hope that this initiative can help us increase the research, production and delivery capacity of vaccines in Indonesia, which will bring more preparedness in handling the next pandemic, and have a significant impact on a better health system in Indonesia,” concluded the Minister.
The CEPI Board Member’s and Investor Council’s Meeting will be held on March 9-13 2024 at the NH Collection Brussels Grand Sablon, Belgium. The meeting of Board members and investors included a series of visitation activities to Vaccinopolis, University Antwerp. Vaccinopolis is part of the University of Antwerp Belgium, led by Prof. Van Damme and operated by the Center for the Evaluation of Vaccination (CEV) which can be a reference in increasing national vaccine research and development capacity.
Vaccinopolis has infrastructure that plays an important role in building a novel product ecosystem in pandemic preparation in the form of a Control Human Infection Model (CHIM) Studies unit, a unit for outpatient clinical study, and L2 and L3 biosafety laboratories.
By the end of 2023, CEPI is committed to increasing PT Bio Farma’s capacity in mRNA and viral vector technology (together with MPP and WHO) by providing financial support of 15 million dollars. One use of these funds is to purchase mRNA technology for the Quantoom Ntensify mini and midi.
Quantoom Biosciences is a biotechnology company that creates mRNA production technology from the DNA sequencing stage/Down Stream Process to the formulation of mRNA (Drug Product)/Up Stream Process using a simple, scalable and effective method. Quantoom Biosciences’ products are Nplify (targeted synthetic DNA production), Ntensify (RNA production), and Encapsulate (lipid nanoparticle/LNP formulation).
Becton Dickinson invited the Deputy Minister of Health and officials from the Ministry of Health to attend the EUROGIN Conference and visit the HPV screening testing laboratory at Karolinska Institutet and Hvidovre Hospital, Denmark.
The EUROGIN Conference 2024 with the theme Innovations in HPV Research and Global Cancer Solution was held from 13-16 March 2024 and continued with visits to the Karolinska Institute Center for Cervical Cancer Elimination, Sweden and the Hvidovre Government Hospital in Copenhagen, Denmark.
The purpose of this study trip is related to sharing best practices:
The results achieved along with indicator achievements are mastery of the new mRNA and viral vector vaccine technology because Exothera, which is a Quantoom group company which also has viral vector technology, programs/modules to accelerate the development of new vaccines, one of which is through the CHIM guidelines, benchmarks in Sweden and Denmark can be used as a model to accelerate the achievement of indicators in the RAN for cervical cancer.
Workshop will explore the critical issues at the various stages of vaccine development including new technology. International experts will lead delegates in developing their understanding in the research, operational, and regulatory challenges of the vaccine market. One of the aims of holding the workshop is to share best-practices and collaborate on projects of common interest for improving vaccine manufacturing.
This workshop is suitable for:
Collaboration between the Ministry of Health, Indonesia and the Ministry of Health, Welfare, and Sport, Netherlands to increase human resource capabilities in Indonesia, especially in the field of biopharmaceutical production in the form of biomanufacturing training.
Leiden Bio Science Park (LBSP) is the largest Life Science Park in the Netherlands with a total of 215 organizations including 150 Life Science & Health companies (startups and multinational companies). LBSP is dedicated as a facility for drug development, biopharmaceutical training, professional training, AI & Data Science, business services, etc.
In the professional training program, LBSP provides training facilities, namely the Biotech Training Facility (BTF), which is a biomanufacturing training program with biosafety facilities that are GMP certified and equipped with production equipment that is appropriate to actual conditions and can be used for pilot plant testing of tools and processes.
The training program at the Leiden Biotech Training Facility (BTF), Netherlands is one of Indonesia’s opportunities to improve competence as a regulator/policy maker, build networks in partnerships and explore information in the field of research and development, mastery of technology and expand access to vaccines and biological products to support achieving vaccine resilience.
Directorate General of Pharmaceutical
and Medical Devices
Ministry of Health of The Republic of Indonesia
Dr. Adhyatma, MPH Building, 8th Floor R.817
Jalan H.R. Rasuna Said Blok X-5 Kav. 4-9
South Jakarta 12950
Hello Kemkes ✆ 1500567
