Good morning.
I am pleased to join you today at the one-day open symposium on marketing authorization and post-approval changes of vaccine.
We are working to achieve better health for everyone, everywhere. We call this universal health coverage, UHC. Everyone should obtain the quality health care service they need, when they need it, right in the heart of the community, without any financial hardship. It is a fundamental human right and mandate of the Government.
It is the objective of the World Health Organization. The article 1 of the WHO constitution clearly states that the objectives of the World Health Organization shall be the attainment by all peoples of the highest possible level of health.
It is also the foundation of health-related Sustainable Development Goal. The Goal 3 is to ensure healthy lives and promote well-being for all at all ages.
It is also clearly the top priority of Viet Nam as cleared mentioned by the Resolution No 20 of the 12th Central Committee of the Communist Part of Viet Nam which was adopted in October 2017.
In order to achieve UHC, people should have access to quality, safe, efficacious and affordable medicine and vaccines.
Today, we will discuss with you on the topic related to universal access to quality and safe vaccines.
The National regulatory authorities (NRA) play a vital role in achieving UHC by providing regulatory oversight of all medical products such as medicines, vaccines, blood products, traditional or herbal medicines and medical devices.
Among others, a key function of WHO is to develop, establish and promote international standards with respect to food, biological, pharmaceutical and similar product. Another key function of WHO is to assist Government of Member States in strengthening health services.
About 80% of global vaccine sales come from five large multi-national corporations. Since 2000, WHO has promoted strengthening vaccine production capacity in developing countries. As of now, about 50 vaccine manufacturers in 17 developing countries are producing and supplying over 40 different types of vaccines to the immunization programme. Viet Nam is one of a few developing countries which produce vaccine within their soil. Looking at the Western Pacific region, there are five vaccine manufacturing countries; Australia, China, Japan, the Republic of Korea, and Viet Nam.
Capacity required to NRAs of vaccine producing countries are different of capacity required to NRAs of vaccine importation only countries. More capacities are required to NRAs of vaccine exporting countries.
Viet Nam has a clear government policy to develop its vaccine industry from importation to self-sufficient and then toward exportation.
Since 2011, WHO has supported regulatory systems strengthening in Vietnam. Viet Nam’s NRA was declared as being “functional” for vaccines in 2015.
WHO’s support to further strengthen capacity of the NRA continued since then. And in November 2018, WHO team visited Viet Nam again to re-benchmark and document the latest vaccine regulatory system in the country. It is expected that the final result will be announced before the end of the year.
As part of WHO’s continued support to regulatory systems strengthening in Vietnam, we have invited an expert from WHO Western Pacific Region in Manila, Dr Jinho Shin, and two experts from WHO headquarters in Geneva, Drs Dianliang Lei and Heidi Meyer, who will facilitate an open symposium with you – marketing authorization holders and manufacturers in Vietnam to exchange of views regarding the pathways, procedures, and data requirements for marketing authorization and post-approval changes of vaccines.
I am very grateful for the leadership and the efforts of the DAV to organise this international symposium and leading discussions, which will help to have better understanding of the latest developments in regulatory procedures, of the current best practices and lessons from case presentations in marketing authorization and changes.
I appreciated your participation today during your busy schedule.
The discussion on evidence of these Good Regulatory Practice will certainly help advance maturity level of the NRA and for developing strategy and actions to better prepare and cope with future changes.
I wish you all a good health and a very fruitful discussion today.
Thank you (Xin cam on).